If you or someone you love have textured breast implants and experienced unusual side effects, you may be at risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Read more to find out about recent breast implant recalls and why you should consider filing a breast implant lawsuit.
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a serious but rare form of non-Hodgkins lymphoma. This kind of cancer affects the immune system and originates in the lymph nodes. It’s important to note, BIA-ALCL is not breast cancer.
BIA-ALCL can appear between the capsule and the implant, in the fluid surrounding the implant. The symptoms include swelling years after the surgery, of which a healthy implant should never swell. It’s imperative you speak with your plastic surgeon or healthcare provider if you experience any unusual symptoms of breast swelling.
National Comprehensive Cancer Network is recognized for its sound research by the Food and Drug Administration, as well as a handful of other research cancer societies. In a recent study, the most common demonstration of BIA-ALCL was built-up fluid around the breast implant (also known as a large spontaneous periprosthetic fluid).
In the report issued by the NCCN, the symptoms occurred anywhere from one, to an average of seven to ten years following cosmetic or reconstructive implantation.
The FDA has issued safety warnings about the unusual cancer that’s popping up both in the United States, and around the globe. As of July 6, 2019, the FDA received 573 medical device reports (MDR) of BIA-ALCL worldwide. Of that total, there have been 33 deaths.
Additionally, 481 out of 573 reports indicated they had Allergan breast implants at the time of their diagnosis – and 12 out of 13 deaths (where the manufacturer was known) included Allergan breast implants. The other 20 deaths did not indicate who the manufacturer was.
“In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body,” the FDA announcement said.
Cases reported in the United States showed no difference in likelihood for BIA-ALCL to occur for those with reconstructive surgery or those who had cosmetic breast enhancement. Of those diagnosed with BIA-ALCL, 56% had them implanted for cosmetic purposed, and 44% had them implanted for reconstructive purposes.
FDA Biocell Breast Implant Update
Health Canada initially issued a recall in May 2019 of Allergan textured breast implants from the Canadian market due to the high incidence of lymphoma. The specific textured implant was once again reported in a high incidence of BIA-ALCL diagnoses.
The Health Canada statement read: “..because the potential risks associated with the implants outweigh their benefits, including the rare but serious risk of BIA-ALCL, Health Canada has suspended the licenses for Allergan’s Biocell breast implants (the only macro-textured implants available in Canada).”
In 2019, at the request of the FDA, the major breast implant manufacturer recalled its entire line of textured breast implants and tissue expanders from the US and worldwide markets. In a press release from July, Allergan announced its textured implants and tissue expanders would no longer be distributed or sold in any market where they’re currently available.
Additionally, healthcare providers should no longer be performing cosmetic or reconstructive surgery with the Biocell saline-filled and silicone-filled textured implants and tissue expanders.
“..at the present time, we believe all individuals who are considering a breast implant of any type be informed of the risk of developing BIA-ALCL.”
-FDA update, 07/25/19
Textured breast implants only account for roughly 10% of implants in the United States. However, the numbers indicate there is a high risk of developing BIA-ALCL.
One of the tests for BIA-ALCL is checking for a fluid collected around the breast implant called CD30. It is a type of protein in cell membranes that abnormally shows up in cases of the lymphoma. If the patient tests positive for CD30, they will need to undergo surgery to remove the ‘capsule’ (or scar tissue) around the implant, as well as the implant itself.
According to the FDA, this is a more extensive and time-consuming operation than a standard implant removal.
As with any cancer or serious ailment, the earlier the better when it comes to treating BIA-ALCL – but this also means coming up with the funds for surgery. Many people have to contend with their insurance companies to cover breast implant removal surgery, even when they are diagnosed with BIA-ALCL.
According to the American Society of Plastic Surgeons, the average out-of-pocket cost of breast removal is $2,566. This does not include anesthesia, operating room facilities, x-rays and medical tests, prescriptions for medication, and other expenses.
When filing a breast implant lawsuit, your attorney will take this into consideration for holding the manufacturer accountable for your BIA-ALCL diagnosis.
The following is a list of the Allergan breast implants and tissue expanders that have been recalled from the market.
Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant). Approved under P990074.
Style 163 – BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants
Style 168 – BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile)
Style 363 – BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, or 363 Low Height Full Projection
Style 468 – BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants
Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants) approved under P020056. The following are the textured styles:
Style 110 – BIOCELL Textured Round Moderate Projection Gel Filled Breast Implants
Style 115 – BIOCELL Textured Round Midrange Projection Gel Filled Breast Implants
Style 120 – BIOCELL Textured Round High Projection Gel Filled Breast Implants
Filled Breast Implants approved under P040046. The following are the textured styles:
Style 410 MF
Style 410 FL
Style 410 ML
Style 410 LL
Style 410 LM
Style 410 LF
Style 410 FX
Style 410 MX
Style 410 LX
Allergan tissue expanders for the breast that have BIOCELL texturing originally cleared as:
Natrelle 133 Plus Tissue Expander (K143354)
Natrelle 133 Tissue Expander with Suture Tabs (K102806)
Filing a Biocell Breast Implant Lawsuit
Any adverse health conditions or complications can be incredibly nerve-wracking. It’s important you find a lawyer who is skilled in compassion for your situation. When filing a Biocell breast implant lawsuit, your attorney will not only hold the manufacturer accountable for a defective and dangerous product– they will look for ways to win financial compensation for the emotional labor behind a BIA-ALCL diagnosis. This includes time spent away from work and family before, during, and after surgery, medical costs incurred, etc.
Uloric (febuxostat) is a medication used to treat gout in adults. Manufactured by Takeda Pharmaceuticals, it was first approved by the Food and Drug Administration in 2009.
Uloric was designed to lower uric acid levels, thus decreasing the likelihood of gout. It is in a class of medications called xanthine oxidase inhibitors. It’s important to note there are very few medicines to treat gout.
In 2019, only ten years after it was first approved, the FDA issued a Boxed Warning for Uloric because there is an increased risk of death while taking the medication.
The FDA said it would be limiting the approved use of Uloric only to patients who experience severe side effects to the alternative gout medication, allopurinol (Aloprim, Lopurin, Zyloprim).
Have you or someone you love experienced an adverse reaction to Uloric (febuxostat)? Read more to find out if a Uloric lawsuit is right for you.
Gout treatment and causes explained
Gout is a form of arthritis that affects nearly 8.3 adults in the United States. It is considered a gout “attack” when there are sudden, severe attacks of pain, redness, swelling and tenderness in the joints. It usually occurs in the the base of the big toe.
The body naturally produces uric acid when it breaks down natural substances found in the body. Uric acid dissolves into your blood, passes through the kidneys, and then into your urine to be eliminated.
However, a gout happens because urate crystals build up in the joints and cause inflammation. This is due to high levels of uric acid in your blood.
Therefore, it’s important to consider certain factors that may increase uric acid levels in your body:
Diet: Alcohol consumption (especially beer), a heavy rotation of meat and seafood, beverages sweetened with fructose (fruit sugar) all contribute to increasing uric acid levels. Medications: Those used to treat hypertension (thiazide diuretics) and low-dose aspring can increase uric acid levels. Anti-rejection drugs used for those who have had an organ transplant may also contribute to increased uric acid levels. Family history of gout: You’re more likely to develop gout if members of your family have been diagnosed. Age and sex: Women tend to have lower uric acid levels than men. However, after menopause, the levels start to compete with those found in men. Men are likely to develop gout earlier between the ages of 30 and 50. Recent surgery or trauma: These factors have been associated with an increased risk of a gout attack. Medical conditions: There are diseases and conditions that increase the risk of gout, those include diabetes, metabolic syndrome, heart, and kidney diseases. Obesity: Uric acid is produced more with those considered obese. Additionally, the kidneys have a harder time eliminating uric acid from the body.
Uloric test study reveals risk of death
When Uloric (febuxostat) was first approved by the FDA, it included a Warning and Precaution over possible cardiovascular events while taking the drug. The agency required Takeda Pharmaceuticals to conduct a postmarket safety clinical trial. Those details are outlined below.
This trial study included over 6,000 patients who were under treatment for gout with Uloric, or the alternative medication, allopurinol. The outcome of the trial concluded there was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and unstable angina in patients taking Uloric.
Compared to allopurinol, Uloric didn’t indicate any differences in an increased risk. However, it was when evaluating the outcomes separately that Uloric was found to increase the risk of heart-related deaths and death from all causes.
Side effects of Uloric
Below are a list of Uloric side effects that can indicate serious health risks and lead to complications if not attended to by a doctor.
Skin redness or pain
Blistering of the lips, eyes, mouth
Fever, or flu-like symptoms
Swollen face, lips, mouth, tongue or throat
Yellowing of the eyes or skin
Pain or discomfort in upper right stomach area
Consult your doctor IMMEDIATELY if you experience chest pain, rapid or irregular heartbeat, shortness of breath, numbness or weakness on one side of your body, dizziness, fainting, slurred speech, blurry vision, or sudden severe headaches.
Filing a Uloric lawsuit
If you or someone you love have experienced any of the devastating side effects of Uloric, including cardiovascular complications, it’s important to speak with a lawyer skilled in representing clients for drug injury lawsuits.
A law firm that has experience in this area can help determine the best course of action and protect your rights. They will make every attempt to make sure the drug manufacturer is held legally liable for your injuries, and that you receive financial compensation.
While you cannot go back in time and undo the devastating impact this medication has had on your life, you may be able to get compensation to help with medical bills and other expenses you incur as a result of the side effects associated with Uloric.
To contact a compassionate lawyer handling these lawsuits, please fill out the form below for a Free Case Evaluation.
Hernia mesh has been the source of controversy in recent years due to the severity of side effects and complications it can cause. Read more to find out if mesh has been causing trouble after surgery.
Hernia mesh goes by a variety of names, such as plugs or patches. It is oftentimes called surgical mesh as well. It is a small, woven “sheet” used in surgical procedures. It helps by providing support to tissue or organs– working as a sort of “sling” to keep the compromised site stable and in place.
Types of hernia mesh
Mesh can be made out of inorganic or organic materials, depending on the reason for its use. Biological and organic materials are meant to be absorbed by the body over time, stimulating new tissue growth intended to support the repair. Inorganic mesh is a more permanent and stable remedy.
There are some animal-derived mesh products, which are constructed out of animal tissue (such as intestine or skin). It has been sterilized and disinfected for use in the human body. This type of mesh is considered absorbable and will degrade over time.
Non-absorbable mesh is intended to stay in the body indefinitely. Medically, it is considered a permanent implant and hernia reinforcement.
As simple as hernia mesh sounds, it is actually quite dangerous. Read more to find out some of the devastating complications mesh can cause, and if a hernia mesh lawsuit is right for you.
What causes a hernia in the first place?
To understand the need for mesh, you have to understand the health conditions that may prompt the use of it in the first place. A hernia is the medical terminology for an organ or tissue that protrudes or exits from its intended place in the body. The hernia usually happens due to straining, pulling, coughing, exercise, or strain from using the toilet.
According to the FDA, the most common types of hernias are:
Inguinal: occurs in the inner groin
Femoral: occurs in the upper thigh/outer groin
Incisional: occurs through an incision or scar in the abdomen
Ventral: occurs in the general abdominal/ventral wall
Umbilical: occurs at the belly button
Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm
A hernia can flare up throughout the day and is sometimes visible from outside of the skin. It may look like a reddened, bulging protrusion that increases in size when strained. The purpose of hernia mesh is to hold the protruding organ or tissue back in its original place; thus eliminating the strain.
Symptoms of a hernia vary depending on the severity, but remember that only a doctor can diagnose.
The symptoms of a hernia include pain that intensifies with movement, bulging red or purple protrusion, inability to have a BM or pass gas, nausea and/or vomiting, of fever. A health care provider is usually detected by an ultrasound or a CT scan, and sometimes an x-ray is needed if there is blockage in the bowel.
Some people have certain medical or health conditions that make it easier for a hernia to occur. There are also activities that increase the likelihood of getting a hernia. Such problems include:
Increased pressure in the abdominal area
A pre-existing weak spot in the abdominal wall
Straining during bowel movements or urination
Strenuous activity such as exercise or lifting weights
Chronic coughing or sneezing
Fluid in the abdomen (ascites)
A combination of any of the above
Hernia Mesh Complications and Symptoms
It’s important to understand the anatomical context of a hernia to better understand the risk of hernia mesh and its associated complications. Though you can take preventative measures to stop a hernia from happening, surgery is really the only remedy to permanently fix a hernia. But what happens if the device used in surgery is unreliable?
The FDA has long been concerned about the effectiveness and safety of hernia mesh. According to the agency, “Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh.”
Furthermore, the most common adverse events reported to the FDA which have prompted recalls of certain mesh were due to bowel perforation and obstructions complications.
There are more complications (outlined below) and conditions that may occur after surgery that involves mesh.
Localized or general pain
Scar-like tissue that sticks tissues together (adhesion)
Blockage of the intestines
Abnormal connection between organs
Mesh migration or erosion
Mesh shrinkage (contraction)
Fluid build-up at the surgical site (seroma)
Many people who have experienced the devastating and painful complications from hernia mesh have had to undergo follow-up surgery to repair or remove the mesh. Sometimes the mesh has become so engrained in the surrounding tissue, that the process of removing the mesh is even more painful than the hernia before.
Hernia mesh removal surgery can be the cause of many problems, some of them include sexual dysfunction in both men and women. This may result in a lack of arousal, issues with pregnancy, pain during intercourse, lack of sexual desire, inability to maintain an erection and/or orgasm.
One of the side effects of defective hernia mesh is organ perforation and damage. Depending on the severity of the situation, some organs may even have to be removed during the mesh removal surgery. That’s because the mesh adheres itself to the tissue lining the hernia repair site.
There is also a risk that comes after hernia repair surgery: painkillers. Many doctors prescribe their patient’s medications such as Oxycontin (oxycodone), Vicodin (hydrocodone), Fentanyl, Carfentanil, Morphine, and others. While this seems like an easy way to control the pain, opioid painkillers are also a nationwide epidemic, as outlined by the Centers for Disease Control. These drugs are addictive and dangerous, and many doctors have overprescribed these medications to their patients.
Contact a Lawyer Handling Hernia Mesh Lawsuits
The pain from hernia mesh failure is debilitating and can severely alter your quality of life. If you or somebody you know has suffered from hernia mesh complications, you should contact a lawyer handling hernia mesh lawsuits.
Xeljanz (tofacitinib) is a medication used to treat certain types of arthritis or ulcerative colitis. It was issued the serious Boxed Warning by the Food and Drug Administration in 2019.
On July 26, 2019, the FDA updated and approved a Boxed Warning for the Xeljanz because it puts patients at risk of blood clots in the lungs and death. This information was gathered after a postmarketing study that monitored how the 10mg dosage interacts with those taking it.
Xeljanz was developed by Pfizer and approved in 2012 to treat adults with rheumatoid arthritis. Additionally, it is used to treat active psoriatic arthritis and ulcerative colitis.
Rheumatoid arthritis is a condition that causes the body to attack its own joints. This causes pain, swelling, and a loss of function in the affected areas.
In 2017, Xeljanz was approved to treat psoriatic arthritis (another condition that causes joint pain and swelling) as an alternative to using methotrexate and similar medications.
Finally, in 2018, Xeljanz was approved to treat ulcerative colitis. That is a condition which causes a chronic, inflammatory disease that affects the colon.
Xeljanz helps to decrease the immune systems activity which is what causes arthritic problems. It was mainly developed as an alternative medication for those who didn’t respond well to other immune system suppressants. Xeljanz is currently prescribed in 5mg doses (including extended release, “XR”), but once increased to 10mg has some very controversial side effects.
Xeljanz Post-Marketing Study and Side Effects
The FDA required the postmarketing study to be conducted by Pfizer, and evaluated patients with ulcerative colitis for a risk of cardiovascular events, cancer, and infections. This was to make sure it was safe to use in elevated doses.
The Data Safety Monitoring Board initially identified the dangerous side effects of an increased dosage of Xeljanz, including death and pulmonary embolism (blood clot in the lungs).
Xeljanz is linked to an increase in blood clots and death when used at 10mg compared to patients taking it at 5mg doses.
The symptoms of a blood clot from Xeljanz may include: If you or someone you love is experiencing any of these conditions, go to a doctor or emergency room immediately.
Sudden shortness of breath
Chest and back pain
Coughing up blood,
Swelling of the legs or arms
Leg pain or tenderness
Unusually red or discolored skin that is painful to the touch
Other Xeljanz (tofacitinib) side effects include:
Urinary tract infection (UTI)
The FDA warns healthcare providers to avoid prescribing Xeljanz to patients with a history of thrombosis. Additionally, it indicates heavily limiting Xeljanz at 10mg to the shortest duration needed.
Filing a Xeljanz Lawsuit
If you or somebody you know has suffered from a blood clot, other serious side effects, or even death from taking Xeljanz, you should contact a lawyer that handles Xeljanz lawsuits.
Health complications from medications can severely affect your quality of life, take time away from work and family, and contribute to other major health episodes later in life. A lawyer skilled in handling a Xeljanz lawsuit will do everything they can to hold the manufacturer accountable.
Fisher-Price Recalls 4.7 Million Units of Rock ‘n Play Sleeper After 32 Infant Deaths Reported
Fisher-Price has announced a product recall of all models of its China-made Rock ‘n Play Sleeper from the market, assuring consumers of a full refund.
The recall was announced on April 12th, 2019, after an extensive investigation by ConsumerReports.org exposed the life-threatening risks of the product for infants.
Nearly 4.7 million products have been recalled, and consumers can contact Fisher-Price for a voucher or cash refund.
The US Consumer Product Safety Commission (CPSC) has published the details of the recall on its website to inform consumers and help protect infants against the risk of death or injury associated with this faulty product.
The Consumer Reports (CR) investigation showed that Rock ‘n Play Sleeper (which sold at major retailers for a price of up to $149) was unsafe ever since it was introduced in the market in 2009. Over a period of nearly 10 years, at least 32 infant fatalities have taken place in Rock ‘n Play Sleepers.
The deaths occurred after the infants rolled over from their back to their side or stomach while unrestrained, or under various other circumstances.
Timeline of the Fisher-Price Product Recall
On April 8th, 2019, Consumer Reports published a detailed investigative report exposing the dangers to the lives of infants while using the Fisher-Price Rock ‘n Play Sleeper.
On April 9th, the AAP (American Academy of Pediatrics) issued a request to the CPSC to order an immediate recall of the product, citing the investigation by Consumer Reports.
On April 11, CR link four additional infant fatalities to inclined sleepers from another company called Kids II, and asked for their recall as well for the same reasons.
On April 12th, Fisher-Price announced a product recall of all 4.7m units sold in the market. The company cited infant deaths as the reason for this recall and asked parents to immediately stop the use of the Rock ‘n Play Sleeper for their babies.
On April 26th, following the action of Fisher-Price, the other company Kids II also announced a recall of 694,000 units of its product Rocking Sleeper, citing infant fatalities.
On May 15th, 2019, Health Canada ordered a separate recall of the same Fisher-Price product sold in Canada. Health Canada cited safety risks as the reason for the recall, and asked caregivers to stop the use of this product for the child’s overnight sleep or naptime.
CR Investigation which led to the Fisher-Price Recall
An investigation by Consumer Reports (CR) into the safety of ‘Rock ‘n Play Sleeper’ from Fisher-Price found it to be linked to at least 32 infant deaths. The product is designed and marketed to help babies sleep better on an incline.
On April 5th, 2019, days after CR completed their investigation and were asked to comment on it, Fisher-Price and the federal government issued a product warning for Rock ‘n Play Sleeper. However, the warning was not deemed to go far enough in the opinion of safety advocates.
CR was informed by multiple medical experts that in order to minimize the risk of accidental suffocation, babies should not be placed at an incline, but flat on their backs on a surface without any soft padding. Fisher-Price Rock ‘n Play Sleeper was not found to adhere to these recommendations.
The safety alert issued by Fisher-Price and the CPSC includes a warning from the CPSC. It asks consumers to stop using Rock ‘n Play Sleeper as soon as an infant is 3 months old or begins to show capabilities of rolling over.
The alert reported 10 infant death incidences since 2015 that were tied to the product. Infants lying on the sleeper were unrestrained and managed to roll from their back to their sides or stomach.
Fisher-Price Refused to Recall the Product despite Reports of Infant Deaths
In spite of these staggering numbers ‘Fisher-Price Rock ‘n Play Sleeper’ was not recalled. Fisher-Price is a part of the Mattel group (children’s products manufacturing giant) who earned $4.5 billion in sales in 2018.
The deaths have only resulted in empty warnings by CPSC and the company. In fact, CPSC still doesn’t have a mandatory safety standard for inclined sleep products targeted at infants.
An emailed statement from Fisher-Price to CR claimed that they would do everything possible to impart the necessary information to parents and caregivers for creating an infant sleep environment which was both safe and sound. They also expressed the loss of a child as being a devastating tragedy.
But, when CR pushed on with its investigation relentlessly, they found that babies much younger than the stipulated 3-month threshold (as stated in the April 5th warning) had died.
Fisher-Price confirmed that in addition to the 10 infant fatalities noted in the CPSC joint release, the company was aware of approximately 22 other deaths since the introduction of Fisher-Price Rock ‘n Play Sleeper in 2009.
However, the company reportedly told CR that they did not believe these deaths to be caused because of the correct usage of the product, citing various situations where the sleeper was clearly used in the wrong manner contrary to instructions and safety warning.
They also stated that there were many instances where an actual health or medical condition was identified as the primary cause of death.
While certain cases were found to be the result of contributing illness and additional bedding, as per data reviewed by CR, there were a number of incidents that were directly associated with using Rock ‘n Play Sleeper, raising concerns about the product’s safety.
Further, products that require restraining a baby (especially, if that product can also rock) is not recommended by the American Academy of Pediatrics (AAP).
Lori Feldman-Winter, M.D., a professor of pediatrics at Cooper Medical School of Rowan University in Camden, N.J. and also a member of the Sudden Infant Death Syndrome (SIDS) taskforce led by the AAP stated that fastening a baby down to a surface and then rocking the baby is not consistent with the SIDS recommendations.
William Wallace, a senior policy analyst at CR voiced that the Fisher-Price Rock ‘n Play was a serious threat to infant’s safety based on the past deaths and injuries, and that all products should be immediately recalled.
Wallace also said that all other inclined sleeper products targeted at infants should be investigated by the CPSC and they should be pulled off the market if they conflict with the safe sleep recommendations as stated by the American Academy of Pediatrics.
The alert issued by CPSC and Fisher-Price on April 8th, 2019 followed a previous similar alert issued by CPSC almost a year ago, where they warned consumers about inclined sleep products (without naming Rock ‘n Play Sleeper) and the risk to infants.
CR was told by CPSC in an emailed statement that they were aware of the other deaths occurred because of Rock ‘n Play and that they were currently focusing on the deaths linked to the rollover hazard.
The statement also claimed the agency to be evaluating Fisher-Price Rock ‘n Play and investigating it for defects, and that if they found evidence that warranted a recall, then they shall not hesitate to make that step.
But, CR’s investigation which was based in part on the CPSC data that was previously undisclosed, and in part on the numerous lawsuits and interviews with products engineers, medical experts, government officials, industry experts, and parents, raised strong concerns about how Fisher-Price developed and marketed Rock ‘n Play in the first place.
The investigation also raised questions about how the product was allowed to be sold in spite of all the deaths and incidents dating so many years back.
CR’s investigation highlighted a tremendous weakness and flaw in the regulatory system designed to protect consumers and children from hazardous products.
A Heart-Rending List of Infant Deaths
CR uncovered the earliest death to have occurred in 2011, with many more in the following years.
For instance, as per a lawsuit against Fisher-Price there is an incident of a mother from Hidalgo County, Texas, who placed her daughter in the Rock ‘n Play Sleeper on her back for the night on Oct. 19th, 2013.
All was well when the mother checked on her baby girl at 4 am, but when she checked again at 7 am, the baby had stopped breathing.
Her head was tilted on the side compressing her airway. She died because her chin was on her shoulder causing positional asphyxia.
CR found the most recent deaths to have occurred in spring 2018 involving a 9-day old baby boy in Copperas Cove, Texas and a month old infant girl in Knoxville, Tenn.
There have been a number of close shaves as well with one being on July 25th, 2014 where a 7-week-old boy placed in the Rock ‘n Play Sleeper was rescued by his grandmother who happened to be in the room.
Jan Hinson, the grandmother, from Greenville, S.C claims to have looked at her grandson and found his head to be cocked in the wrong way. He was lifeless and blue all over. She got the little boy to breathe again who was declared fine after a day’s stay at the hospital.
Hinson is also a lawyer and is currently representing Evan and Keenan Overton from Virginia, whose son died while taking a nap in the Rock ‘n Play Sleeper.
In 2017, just a few days before Christmas, Keenan was sleeping on the couch with 5-month-old Ezra asleep in the Rock ‘n Play Sleeper.
Keenan upon waking in the middle of the night found Ezra to be on his stomach, lifeless, and not breathing. Keenan yelled for Evan to call 911.
Evan sobbed that Ezra’s body was hard and blue all over. His son did not feel real in his arms. The baby was pronounced dead due to asphyxia at the hospital and while the Overtons say that Ezra was buckled, the death certificate says the baby was unrestrained.
As the Overtons came to grasp what had happened in the weeks and months following Ezra’s funeral, they came upon the controversy surrounding Fisher-Price Rock ‘n Play.
The new parents had trusted Fisher-Price and the product to be safe for their baby’s sleep time because that was the way it was marketed. The product is marketed ‘for naptime and nighttime’ and the package clearly refers to the product as an ‘inclined sleeper designed for all-night’s sleep.’
However, the internet search carried out by the couple revealed a whole different story. There were multiple posts by parents and doctors labeling the product as a safety hazard.
The Overtons learned that Fisher-Price Rock ‘n Play Sleeper due to its inclined position was a serious threat and increased the risk of infant fatality.
The product had been a hand-me-down from the Overtons neighbors who claimed it to be a lifesaver when their child was an infant. However, the Overtons after reading up about it became convinced that the opposite was true.
Evan posted a comment on Amazon on Jan. 6th, 2018 warning parents not to buy Fisher-Price Rock ‘n Play and labeled it as a horrible contraption that claimed the life of his son and should not be marketed as a sleeper.
When Fisher-Price was asked about the Overton incident by CR, they responded by saying that it is an unimaginable tragedy to lose a child. Fisher-Price also confirmed that this incident was part of the 10 incidents cited by the company in the April 5 joint CPSC alert.
A History of the Product’s Dangers
The website of Fisher-Price states that the company first got the idea for Rock ‘n Play Sleeper and commenced its development when one their designers had a baby boy who couldn’t sleep because of acid reflux troubles.
The designer’s pediatricians suggested keeping the infant’s head at an elevated angle, which prompted her and the company to build a sleeper that would keep a baby’s head at a 30 degree incline while sleeping.
CR was told by Fisher-Price that the company engaged a reputed engineering and scientific consulting firm that assessed the risk of Rock ‘n Play Sleeper to be lower than that of cribs, cradles and bassinets.
The medical consultant hired by Fisher-Price was found to be a physician from San Antonio called Gary Deegear, M.D., as per documents filed by the company in an Atlanta lawsuit. According to these documents, Deegear assured Fisher-Price about the safety of Rock ‘n Play Sleeper.
For instance, Kitty Pilarz who is Mattel’s vice president of product safety and regulatory compliance wrote in an email that Dr. Deegear claimed pediatricians from all over to recommend placing infants with acid reflux at an incline of 30 degrees or in a car seat.
However, there are several concerns about this advice given by Dr. Deegear.
For starters, according to the Texas Medical Board, Deegear is not a pediatrician or a sleep specialist. He is a family practice doctor and CR could not reach him for comment even after multiple attempts.
Another reason is that the National Institute of Child Health and Human Development along with the AAP have long counseled against keeping infants or allowing them to sleep unsupervised while in a reclining position.
Shortly after the joint alert issued by Fisher-Price and the CPSC, the AAP tweeted a warning about not using the Rock ‘n Play Sleeper for routine sleep. They advised to always strap the baby and never leave one unattended if the sleeper was used for soothing purposes.
Feldman-Winter stated that the AAP does not recommend babies to be placed with their heads in an elevated position while sleeping since that position can result in accidental strangulation and suffocation in bed.
Instead, babies should be placed on their backs, alone and unrestrained, on a flat and firm surface, such as a mattress with a fitted sheet in the play yard, crib or bassinet.
Experts advise parents not to use a stroller, car seat, sling, swing, wedge, or other similar products for unsupervised sleep.
This recommendation, as per Feldman-Winter, applies to all babies, including the ones with acid reflux. She understands the desperation parents feel when their babies are in pain or crying and can’t sleep, and recognizes that some parents have heard about putting a child at an incline to ease the problem.
However, there is no evidence that suggests acid reflux can be eased by placing the baby at an incline. She further stated that many parents think it is safe to keep babies in an elevated sleep position, but it is not.
The AAP doesn’t recommend using any sleeping device that requires a baby to be restrained during routine use because a baby may be incapable of moving after rolling into an unsafe position, causing strangulation or suffocation.
These products are deemed acceptable, as stated by Paul Gaudreau, a mechanical engineer who has experience in the car-seat industry and currently works for UPPAbaby, because that is the safest position in the event of a car crash.
Medical experts also warn that straps in car seats can cause strangulation which is the reason why Gaudreau always steered the company he worked for to not develop inclined sleepers.
The basic advice that recommends babies to be placed on a firm and level surface dates back to 1994, which is well before Rock ‘n Play Sleeper was developed by Fisher-Price.
In 1994, the AAP and other infant-safety related groups developed the “Back to Sleep” campaign aimed at reducing the risk of sleep-related deaths and SIDS. The campaign is now labeled as “Safe to Sleep” and has successfully helped bring down the rate of SIDS by 50%.
Roy Benaroch, M.D.is an associate adjunct professor of pediatrics at Emory University in Atlanta and has blogged about the potential safety risks of the Fisher-Price Rock ‘n Play Sleeper.
He told CR that parents are usually not able to make an enlightened decision because they are confused on account of sleepless nights, crying and cranky baby, and general exhaustion.
He said that parents are ready to grasp at any solution that comes their way, without really understanding the risk they assume by using inclined sleepers. Benaroch asserted that parents who use Rock ‘n Play Sleeper are putting their baby at the risk of infant fatality.
‘Rock ‘n Play Sleeper’ was marketed along with bassinets by Fisher-Price when it was first introduced. However, in 2010, less than a year later, the CPSC began to form drafts to revise infant sleep surface standards. This included bassinets.
They issued a proposed rule which would require all products to be flat and firm. The products could be at an angle below 5 degrees, though not while rocking or swinging.
Pilarz at Mattel, rather than adjusting the incline of their products reached out to CPSC for a revision of the proposed rule.
She claimed that not making the change on account of products like Rock ‘n Play Sleeper could potentially increase the risk of injury as exhausted parents looked elsewhere and substituted for products that could be more dangerous.
Ultimately, CPSC excluded products with an incline greater than 10 degrees from their mandatory standards for bassinets and cradles in October 2013.
Armed with this exclusion, Fisher-Price with other industry reps went to ASTM International. This organization includes representatives from public, government, and the industry in question to set voluntary safety standards of consumer products. They applied for voluntary standard for a new category – the inclined infant sleepers.
Some ASTM members had objected creating a new category and setting voluntary standards for these products.
The executive director of Kids in Danger, Nancy Cowles claimed that by setting a standard, parents would be coerced into believing that the products must be safe. Kids in Danger (KID) is a nonprofit organization focusing on reducing injuries in children and infants due to consumer products.
Cowles worried that the voluntary ASTM standard would create confusion and give parents a sense of false security about inclined sleepers which were anything but secure.
Nevertheless, ASTM went on ahead to develop a voluntary standard for the inclined sleeper category and appointed Michael Steinwachs as chairperson.
Steinwachs was employed by Fisher-Price at the time as one of the primary engineers of the Rock ‘n Play Sleeper. In 2015, the voluntary standard was established for infant inclined sleep products.
Even though Cowles at KID was disappointed, she wasn’t surprised because even with talks about safety issues, parents just keep buying products, and companies keep on selling them, justifying singular incidents as the parent’s fault.
Product Warnings from Other Parts of the World
According to documents filed in the Hidalgo County lawsuit, there were many health and regulatory agencies that did not trust the inclined sleeper.
For instance, in January 2011, Australian regulators wrote to Mattel explaining their reasons as to why the product should not be marketed as a sleep product.
They said that the Rock ‘n Play Sleeper was at odds with widely accepted infant regulations that state such products to not be used as an infant bedding alternative.
The Australian regulators also claimed that the product’s angles could make babies’ heads fall forward that could cause obstruction to airways. The sleeper is still not sold in Australia as confirmed by Fisher-Price.
In Canada, the product was reclassified as a ‘soother’ from a ‘sleeper’ and is now re-marketed as the Rock ‘n Play Soothing Seat.
This was after a Health Canada representative wrote to Mattel Canada in February 2011 about their concerns in light of recommendations by the Canadian Pediatric Society and the Public Health Agency of Canada.
Despite misgivings from various health organizations, Rock ‘n Play is still marketed as a ‘sleeper’ in the United Kingdom.
The Royal College of Midwives in the UK in February 2011 told Fisher-Price that they would not endorse Rock ‘n Play as a sleeper because they thought it was suitable for only short periods of supervised play.
A Fisher-Price employee, after receiving this news, wrote in an internal email that the findings from the testing of the product by the Royal College of Midwives did not have good implications for a UK launch.
What Should the Parents Do?
Safety experts now agree and suggest that people who may still be using Fisher-Price Rock ’n Play Sleepers should stop their use immediately for an infant’s routine sleep. They recommend that the best way to put the babies on their bed is alone.
The baby should be put on his or her back, over a flat, firm, flat mattress in a bassinet, play yard, or crib.
The product recall from Fisher-Price should be taken seriously by every parent to protect their infant against the risk of injury or death due to a faulty product.
Filing a Lawsuit Against Fisher-Price For Rock ‘N Play Recall
If you or a loved one has suffered from the death of a baby due to the defective design of the Fisher-Price Rock ‘N Play, you may be entitled to compensation by filing a lawsuit. To contact lawyers handling lawsuits against Fisher-Price, please use the form below.
Hundreds of army veterans all over the United States have filed defective combat ear plug lawsuits against 3M Company after whistleblower allegations that stated a defense contractor sold the military defective Combat Arms Earplugs, Version 2 (CAEv2) from 2003 to 2015.
Because the military earplugs failed to maintain a tight seal, dangerously loud sounds were able to slip through without the wearer’s knowledge.
The dual-ended 3M CAEv2 earplugs, which have now been discontinued, were reportedly standard issue for members of the military service from 2003 to 2015. The 3M ear plug lawsuits were filed in the United States District Court for the Western District of Texas- Waco Division.
According to a copy of one lawsuit that the Military Times received, the lawsuits allege that 3M Company, based in Minnesota, made earplugs with a defective design and failed to warn users of the defect or to provide proper instructions for their use.
It is alleged that the failure resulted in the loss of hearing, loss of balance and tinnitus in those who used the earplugs during their military service.
Over 100 lawsuits have been filed by multiple law firms. In a statement, one lawyer said that due to the widespread damage that veterans suffered as a result of the actions of 3M, the 100 cases so far are just the tip of the iceberg of lawsuits that will be filed so that 3M can be held accountable.
Department of Justice Helps Resolve 3M Earplug Lawsuit Against the Company
In a controversial whistleblower lawsuit that was filed on the behalf of the US government, a leading qui tam lawyer made allegations that 3M Company and Aearo Technologies, Inc. (which was the company’s predecessor), had knowledge of the defect in the earplug’s design since 2000, when the earplugs that were intended for use in combat failed to show any benefits in noise reduction.
Yet, the 3M whistleblower lawsuit alleged that 3M continued to sell the combat arms earplugs to the Defense Logistics Agency. This is the agency that supplies equipment to the US army, air force, as well as navy personnel.
3M Company, in its response to the whistleblower complaint, admitted that Aearo had conducted a test on the earplugs in 2000 and that the result of the test was a Noise Reduction Rating (NRR) of 0, which means that the combat earplugs had no benefits in noise reduction.
Later, the US government intervened with slightly different allegations in the whistleblower lawsuit.
The United States alleged that 3M and Aearo Technologies were fully aware that the Combat Arms Earplugs version 2, or CAEv2, was too short to be properly inserted into users’ ears. It also added that 3M failed to disclose this information to the US government and delivered the earplugs knowing full well that they were defective products.
In the settlement agreement for the whistleblower combat arms earplugs lawsuit, 3M agreed to make a $9.1 million payment to the United States government.
Allegations Made in the Lawsuits Against 3M
The US Government’s allegations against 3M were brought through the enforcement of the False Claims Act.
According to the Justice Department, the company previously agreed to make a payment of $9.1 million in an attempt to resolve the serious allegations that it purposely sold the defective earplugs to the Defense Logistics Agency without disclosing any information about the defects that reduced the hearing protection.
The Justice Department said that while that case has come to a resolution, all claims within the settlement were allegations only, and that liability had not been determined at that point.
According to the copy of the lawsuit, that has not prevented veterans from seeking punitive damages from 3M after the “gross negligence” of the company caused them to develop hearing issues.
The lawsuit reads that since late 2003, the Combat Arms earplugs were touted as having the capability to allow users to hear commands from friendly soldiers and approach enemy combatants, without any impairment, in the same way as if there was nothing in their ears.
It is alleged in the documents that the employees of 3M had knowledge of the earplug defects as early as 2000.
According to the lawsuit, although 3M conducted testing and found defects in the earplugs, they falsified certification and stated that the testing they conducted complied with military standards.
A lawyer involved in the lawsuit said that it was rather shameful that 3M would intentionally provide equipment with defects to service members of the U.S. Army, knowing full well that those service members would rely on that defective equipment while engaged in combat.
He added that their fraud caused America’s warriors’ life-long injuries and that the company’s actions cannot and should not be tolerated.
The US government entered into a contract with 3M in 2006. The company supplied the military an estimated quantity of 15,000 packages of earplugs per annum, with 50 pairs per package.
The supply earned the company a guaranteed price of a minimum of $9 million in sales for the year. 3M sold the earplugs to the military until 2015, when the product was discontinued.
However, the lawsuit says that the company did not recall the defective pairs and thus, it is likely that they are still used by soldiers as well as being sold by other vendors.
The defective earplugs may have resulted in significant loss of hearing in many military veterans, including many combat veterans who were deployed two tours in Iraq or Afghanistan, reserve members who were in the US, but fired weapons on a regular basis for training, as well as personnel of the Air Force and the Navy.
Current and former military service members who served at any time between 2003 and 2015 may be entitled to receive compensation from 3M for their loss of hearing or developing tinnitus.
According to a 2011 report by the Government Accountability Office, hearing impairments, including conditions such as constant ringing associated with tinnitus, can be debilitating as well as permanent and has been the No. 1 disability connected to military service that veterans have reported since 2005.
The complaint states that tinnitus and loss of hearing are top health conditions that are diagnosed and treated at medical centers for the veterans, costing the department billions of dollars in benefit claims.
Army Veteran from Maryland Sues 3M
There are a large number of law firms across the United States beginning to file lawsuits against 3M Company over earplugs supplied to the military that the US Justice Department alleged were defective.
Joshua M. Keiner, an army combat veteran, filed the first case against 3M in the US District Court in Maryland. He served two tours in Iraq and the earplugs were issued to him during those tours.
The lawsuits on behalf of service members came after 3M offered a $9.1 million settlement for a federal lawsuit. As mentioned earlier, the settlement was an attempt made to resolve allegations that the company knowingly supplied defective earplugs to the US military.
According to the Justice Department, 3M did not admit liability in the settlement, even though officials had alleged that the Combat Arms earplugs, or CAEv2, were too short to be properly inserted into users’ ears and the company did not disclose the defect.
The suit filed by the Justice Department and Mr. Keiner’s complaint alleged that the defect caused the earplugs to come loose in the ear of the wearer and this, in turn, allowed damaging noise through.
In his suit, Mr. Keiner said that he suffered from tinnitus in addition to other damages that resulted in medical care costs, loss of wages and pain and suffering.
With similar lawsuits being filed across the United States, some lawyers suspect that they will become part of a multidistrict litigation.
This type of litigation is a legal procedure for complex cases in federal court in which common cases are consolidated into one district for pretrial proceedings as well as discovery. One lawyer interviewed added that thousands of veterans have contacted the law firm and that the issue is expected to continue to grow.
The firm plans to file hundreds of more lawsuits in the weeks and months to come to make sure that each veteran that has suffered damage due to the defective ear plugs receives compensation.
Retired Marine Files Lawsuit Against 3M for Earplug Hearing Loss
A former Marine captain, Matt Morrison from New Jersey has filed a lawsuit against 3M, claiming that the company’s defective ear plugs caused hearing loss.
He said that he lost much of his hearing because of standard-issue earplugs that he wore during three combat deployments. He has filed a lawsuit against the company at the Federal Courthouse in Philadelphia.
Capt. Morrison claims that 3M’s defective combat earplugs directly caused him to lose his hearing completely in his right ear.
He said that the gear soldiers are issued is everything from a helmet, eye, and ear protection, to a flak jacket and that he never thought that the gear would be defective or faulty and result in this type of injury.
A former officer in the Navy and Capt. Morrison’s lawyer, said that service people deserved to be provided state-of-the-art equipment for the battlefield, yet 3M provided earplugs that they knew had defects.
He also said that the testing proved that what the company represented to the government and the US military was nothing but a lie.
Capt. Morrison’s tours of duty between 2007 and 2013 included two in Iraq and one in Afghanistan. This is when he was exposed to ground-deployed heavy machine guns, explosives, rockets, and small arms fire.
His lawyer said that 3M’s actions are a blatant example of fraudulent profiteering that is at the expense of the US military. A lawyer who specializes in product liability cases and workplace injuries, he also said that the CAEv2 were the most popular deployed earplugs in the military between 2005 and 2015.
According to the lawsuit, the combat earplugs allowed damaging sounds to enter the ear canal, around the outside of the earplug. Their flaps fold back, causing them to loosen up and expose the inner ear to extremely sharp noises that the earplugs are actually supposed to protect it from.
35-year-old Capt. Morrison said that he was devastated to learn that despite taking every precaution, his hearing loss is irreparable.
He said that he did have any signs or symptoms of hearing issues prior to joining the military. He was diagnosed with tinnitus and hearing impairment at his discharge medical physical.
Facts About the 3M Combat Arms Earplugs Lawsuits
Here is a look at some of the facts about the lawsuits involving 3M Combat Arms earplugs.
Affected Dates: Personnel of the US military that served between 2003 and 2015 experienced loss of hearing and other hearing impairments after they used standard issue 3M combat arms earplugs.
Allegations of the Lawsuit: According to the False Claims Act lawsuit, military contractor 3M Company allegedly knowingly sold 3M combat arms earplugs to the US military between 2003 and 2015.
In other words, the “known” defects did not meet the safety standards of the military as the company claimed and allegedly caused those who wore the earplugs to develop tinnitus/hearing loss.
Defective Dual-Ended Earplugs: 3M’s dual-ended combat earplugs listed in the lawsuit had yellow on one side and green on the other. Each color indicated a certain level of protection of noise for the soldier wearing them.
However, because they were too short, the earplugs’ basic function was faulty. The earplugs could also loosen in the wearer’s ear without them knowing it.
Both of these shortcomings in the product design exposed military personnel to noise levels that were damaging, and this, in turn, contributed to the loss of hearing and/or tinnitus.
The outcome of the Case of the Whistleblower False Claims Act: A lawsuit verdict in July 2018 found 3M guilty of selling a large number of defective earplugs meant for combat use to the US military without disclosing that wearers could develop hearing loss as well as tinnitus due to the faulty earplugs.
As a result, the US military received a settlement of $9.1 million from 3M.
$9.1 Million Settlement: Because the original whistleblower case was filed under the False Claims Act, the US military directly received the settlement funds.
This means that the compensation that was awarded goes straight to the government to cover the expenses on purchasing the allegedly defective combat arms earplugs from 3M. However, the settlement from 3M does directly benefit military personnel who were injured as a result of wearing the defective earplugs.
The settlement involved claims that 3M and Aearo Technologies Inc., its predecessor, became aware of the earplugs’ flaws back in 2000 and failed to disclose this information to the US military prior to finalizing the contract. 3M had also initiated lawsuits on patent infringement against competitors who were selling earplugs that reduced loud sounds effectively in military conditions.
New Lawsuits Involving Combat Arms Earplugs: In an effort to recover compensation on their behalf, individual 3M combat arms earplugs lawsuits are being formed by lawyers specific to personal experience and injuries.
Financial compensation recovered from the lawsuits can be used to cover not just medical bills, but also for your pain and suffering, and a wide range of other damages that result from the alleged defective combat arms earplugs.
FAQs about the 3M Combat Arms Earplugs
Here is a look at some of the most common questions asked about 3M combat arms earplugs (CAEv2).
Q. What was the intended purpose of the 3M combat arms earplugs?
A: 3M Company won an exclusive contract to sell earplugs to be worn in combat to the United States military, and sold millions of earplugs to the armed forces in the US between 2003 and 2015.
The dual-ended earplugs came with black and yellow ends and were intended to offer versatility in providing hearing protection while enabling service members to communicate when they needed to.
One side of the earplugs was intended to block all kinds of sound, including voices. The other side was designed to block any kind of loud impulses or sounds on the battlefield while at the same time allowing spoken commands and words to come through.
Q. What was the defect in the combat arms earplugs?
A. Instead of blocking sound as they were intended to, the design that 3M used in their combat arms earplugs allowed them to loosen in the wearer’s ear. According to the whistleblower, unless folded back, the earplug’s yellow fins prevented a tight seal to form in the ear canal of the wearer.
Testing that the company that invented the earplugs conducted showed that the earplugs had a Noise Reduction Rating (NRR) of zero – just as 3M admitted in a False Claims Act lawsuit. Service members, as a result of this defect, may have suffered the loss of hearing and tinnitus from combat noise, aircraft noise, or firing weapons in training.
Q. What are the whistleblower provisions of the False Claims Act?
A: Under the whistleblower provisions of the False Claims Act, private parties have the ability to bring legal action on behalf of the government against any party who submits claims that are fraudulent in an attempt to collect government funds.
Q. Can veterans be compensated beyond VA disability from a 3M combat arms earplugs lawsuit?
A: Through the investigation conducted by some law firms, it has been learned that a number of affected members of the military receive hearing aids and partial disability from the Department of Veteran Affairs (VA), but they may be eligible to be compensated by 3M Company for injuries that they battled including hearing loss, tinnitus, and any other serious health problems as a direct use of these defective earplugs.
Q. Are the 3M Combat Arms Earplugs Lawsuits a Class Action?
A: No, the 3M combat arms earplugs lawsuits appear as if they will be litigated as a mass tort, not a class action.
In a class action, a group of plaintiffs or single plaintiff seeks to represent all the other people who are in a similar situation – in most cases, people who have not filed their own individual lawsuits.
In a mass tort, every plaintiff files their own individual lawsuit, but the cases, more often than not, are consolidated in front of one judge.
Lawyers of Plaintiffs are Ready to Battle Over Allegedly Defective Combat Earplugs
Veterans from across the United States who suffered hearing loss, tinnitus, and other hearing impairments after wearing defective 3M combat arms earplugs are suing the company to recover compensation for damages.
In addition, lawyers are also all set to file several thousand lawsuits on behalf of members of the US military over the many defective earplugs that the multinational company sold to the United States government for more than 10 years.
So far, more than 100 lawsuits have been filed against 3M by individual service members, the majority of whom are veterans. They allege that the company’s dual-ended earplugs, used in combat as well as training, had a defective design that resulted in ringing in the ears, or tinnitus, and hearing loss.
3M was the exclusive supplier of earplugs to the military from 2003 to 2012. According to the lawsuits, over 800,000 former members of military service now suffer from hearing damage due to the defective earplugs.
The Department of Veteran Affairs now spends over $1 billion annually for treating hearing damage that service members suffer from.
Lawyers who are filing lawsuits against 3M say that there are people who served the United States with honor in highly dangerous conditions and are now suffering serious, life-altering injuries as a result of the misconduct of the company.
They say that all allegations made against the company are true and they have every intention to prove them at trial, whenever and wherever they are given the opportunity to do so.
The lawyers are working hard to make sure that 3M Company is held liable for causing injury to military personnel and that service members receive the compensation they deserve for their injuries and for the costs incurred for medical treatment as well as the pain and suffering they experienced.
Prilosec and Nexium lawsuits blame the makers of PPIs for having failed to warn patients about the risk of contracting chronic kidney disease, kidney/renal failure, acute kidney injury, or acute interstitial nephritis. These are kidney issues that can require dialysis or lead to the death of patients.
Recent news reports have been covering the many health risks that come with PPIs. A new study suggests that some heartburn drugs, called proton pump inhibitors, that are used by millions of people in the United States are linked to a higher risk of death.
These drugs are available by prescription and over the counter and are used to treat ulcers, heartburn, and a variety of other gastrointestinal problems. Other recent studies have also associated PPIs to a number of potential health risks, including kidney disease, heart disease, bone fractures, stomach infections, dementia, and pneumonia.
PPIs like Nexium and Prilosec suppress excess acid in the stomach. Prescription formulas are generally taken for long periods by patients with severe conditions while lower-dose OTC formulas are approved by the US Food and Drug Administration for short-term use only.
What are Nexium and Prilosec Used For?
As mentioned already, proton pump inhibitors, or PPIs, are used to reduce acid production in the stomach. When you ingest a PPI, it works to block a stomach enzyme that produces H+/K+ ATPase, a stomach acid. Ulcers in the stomach, small intestine, and esophagus are then able to heal, and new ulcers are prevented from forming by the PPIs.
Some of the gastrointestinal disorders that are associated with excessive secretion of acid are:
Gastroesophageal reflux disease (GERD)
Stomach or peptic ulcer
Stress Ulcer Prophylaxis
PPIs are also used in combination with antibiotics to eradicate a bacterium called Helicobacter pylori that together with acid causes stomach and duodenum ulcers.
List of PPIs
Generally, prescription PPIs are used to treat ulcers, GERD, and inflammation of the esophagus and are not supposed to be taken for longer than 2 weeks (14 days) or more than 3 times a year.
Some of the common PPIs used to treat any of these conditions (their generic names are included) include the following:
Zegerid (omeprazole/sodium bicarbonate)
Side Effects of Nexium and Prilosec
You might think that you are doing your body a favor by taking a PPI. They help in managing the symptoms of heartburn and make you feel better, right?
Plus, many PPIs are OTC and not prescription drugs, so you might not think that it is a big deal. However, like any other drug, PPIs can come with a range of side effects – some are mild, others serious.
In 2012, the FDA issued a warning to consumers about the potential for diarrhea that does not improve after people take PPIs and also a warning in 2010 about the increased possibility for wrist, hip, and spinal fractures. The latter was issued for patients who had received PPIs in high doses or used them for a year or longer.
Therefore, as a precaution, the FDA revised the Drug Facts section on labels. It has also already been mentioned earlier that the use of PPIs has been associated with increased risk for kidney disease, dementia, and other serious health conditions.
Some of the most common side effects of PPIs include the following:
PPIs may increase the risk of Clostridium difficile colon infection. Prolonged use of the drugs also reduces Vitamin B12 (cyanocobalamin) absorption. On top of this, long-term PPI use has been linked to low levels of magnesium (hypomagnesemia).
When patients taking these drugs for long periods of time were analyzed, an increased risk of heart attacks was found. Therefore, it is extremely important for patients to use the lowest doses and the shortest treatment duration necessary for the condition that is being treated.
Other serious side effects that are associated with PPIs include:
Reduced kidney function
Reduced liver function
Serious allergic reactions
Toxic epidermal necrolysis
New Study Shows Long-Term PPI Use Increases Risk of Death
Researchers from Washington University School of Medicine in St. Louis recently conducted a study to find out if people who used PPIs were at greater risk of dying.
They had a question: If it is true that these drugs are linked to all of the aforementioned health issues, does that translate to an increased risk of mortality?
The researchers of the study examined medical records of about 275,000 PPI users and nearly 75,000 people who took H2 (histamine 2) blockers, which is another class of drugs for reducing stomach acid. The study concluded that there is an increased risk of death among those who use PPIs.
When patients taking H2 blockers were compared with those taking PPIs for 1 to 2 years, it was found that PPI users had a 50% increased risk of dying over the next 5 years.
Researchers said that because they are readily available, people think that they are safe. But they should keep in mind that taking these drugs comes with real risks, especially when they are consumed for long periods of time.
Although the recommended treatment period for most PPIs is short – for instance anywhere between 2 to 8 weeks for ulcers – many people take the drugs for months or even years. People are often prescribed these drugs for a sound medical reason, but then physicians do not tell them when to stop it and patients just continue to get refill after refill.
The researchers of the study said that there should be periodic reassessments as to whether it is required for people to be on the drugs. In most cases, people do not need to be on PPIs for a year, or more than that.
The same chemical compounds in prescription PPIs are present in OTC ones, just at lower doses, and there is no way to determine the exact period of time that people should stay on them.
The FDA recommends not taking PPIs for more than 4 weeks before consulting a doctor.
Risk of Chronic Kidney Disease From Taking Nexium or Prilosec
While studies of the use of PPIs have found increased risks in a number of different medical issues, including pneumonia, strokes, bone fractures, dementia, and certain infections, many studies have also examined the use of these drugs and the risk of kidney problems.
This includes studies that have looked at the association with chronic kidney disease (CKD) that is defined by the National Institutes of Health as any condition that results in a reduced function of the kidneys over a period of time. It may take years for CDK to develop and can cause ESRD, or end-stage renal disease. Patients who develop this disease require dialysis or a kidney transplant to survive.
A study that examined the use of PPIs and the risk of CKD found that people who were on PPIs had a statistically significantly higher risk of developing the disease when compared with people who were not on the drugs. The study also linked a higher risk of developing chronic kidney disease with twice-daily dosing compared to once-daily dosing.
It was one of at least three studies that were published in 2016 that drew a conclusion between proton pump indicators and CKD. Another of these studies found that there was a statistically significant increase in the risk of developing CKD and death for subjects who used these medications.
The study concluded that there was a need for better education among health care providers about the potential side effects of PPIs like Nexium and Prilosec.
A third study found that patients using PPIs had a statistically significant increase of 96% in the risk of ESRD and a statistically significant increase of 28% in the risk of CKD compared to patients using H2 blockers for acid-related indications.
As already mentioned, H2 blockers are a different class of drugs that are used to reduce acid in the stomach and includes brand-name products such as Pepcid AC, Tagamet, and Zantac, to name a few.
Nexium and Prilosec Lawsuits
The most recent data from the United States Judicial Panel on Multidistrict Litigation reveals that there are over 4,200 lawsuits pending against Nexium, Prilosec, and other proton pump inhibitors. Nexium and Prilosec are two of the most common OTC and prescription drugs used to treat frequent heartburn.
These and other PPIs, like Prevacid, have recently been at the center of a large number of lawsuits as consumers suffer kidney complications such as kidney injury, chronic kidney disease, and acute interstitial nephritis, which is an extremely serious condition that can result in kidney failure.
Why are Patients Filing Prilosec and Nexium Lawsuits?
Also known by its generic name omeprazole, Prilosec is a PPI developed by AstraZeneca to block excess acid in the stomach from flowing into the esophagus and leading to painful heartburn.
The delayed-release drug with omeprazole as its active ingredient was the first of its kind that the FDA approved in 1989 for prescription use. In 2003, it also became the first in its class to be approved by the FDA under the name Prilosec OTC for over-the-counter sale.
A second-generation drug for heartburn manufactured by the same company, Nexium was approved by the FDA and introduced to the market in 2001. AstraZeneca used esomeprazole instead of omeprazole – both ingredients are very closely related chemically.
According to reports, the drug was likely developed by the manufacturer to stay in the billion-dollar industry for heartburn medications and maintain profits, because, in 2002, their patent for Prilosec ran out.
Nexium and Prilosec are commonly used to treat the following conditions:
Gastroesophageal reflux disease (GERD) or acid reflux
Zollinger-Ellison syndrome (long-term treatment)
While originally available only by prescription, the Prilosec formula was changed by AstraZeneca for the use of omeprazole magnesium in the making of Prilosec OTC used in the treatment of frequent and recurrent heartburn. Patients are required to take the tablets over the course of 14 days so that heartburn will gradually improve and they can repeat it every 4 months. Prilosec OTC is marketed by Procter & Gamble.
Nexium24HR, the OTC version of Nexium, was not available until 2014. As with Prilosec, its formulation was changed to esomeprazole magnesium and the drug can now also be used with the same treatment course as the OTC version of Prilosec. Nexium OTC is marketed by Pfizer Inc.
Initially, AstraZeneca warned consumers of some potential side effects that came with Nexium and Prilosec, such as diarrhea, headache, dizziness, nausea, vomiting, stomach pain, or allergic reactions in some people. However, as the drug became more popular among consumers, researchers conducted studies and found that there were far more serious risks than originally thought.
Dangers of Nexium and Prilosec
Each year, millions of people in the US rely on Nexium and Prilosec to treat frequent heartburn and other conditions. However, in the last several years, in particular, there have been a number of studies that have been published about the serious side effects of Nexium, Prilosec and their main ingredients.
Around 2010, there were a number of studies that came out, indicating an increase in the risk for bone fractures in the wrist, hip and spine when the drugs are used over a prolonged period of time.
Researchers were divided when it came to the evidence, and it was ultimately determined by the FDA a year later that people who require only a low dose of the PPI over a period of one year or less are not at risk and there was no need to add an additional safety warning at the time. However, even more, serious and dangerous side effects have come to light in recent years.
Some of the dangerous side effects of Nexium and Prilosec include:
Short-term kidney injuries and problems
Low magnesium levels
Acute interstitial nephritis (AIN)
A study in 2016 that featured in JAMA Internal Medicine stated that nearly 11,000 participants used Prilosec and other such PPIs. These PPI users were found to have a 20% to 50% higher risk of chronic kidney damage compared to people who did not use PPIs.
Chronic kidney disease can progress over time and decrease kidney function severely, which in turn can potentially result in kidney failure and the need for a kidney transplant.
Additional serious health effects have been found in other studies. According to one recent study, Nexium and Prilosec could result in an increased risk of gastric cancer. Researchers found that patients with previous stomach infections had more than double the risk.
It has also been determined by other studies that there is a 21% increase in the overall risk for stroke and an increase of upwards of 21% for a heart attack for those who use this medication, especially with long-term use. The regular use of omeprazole has even attributed to increasing the risk of seniors developing dementia by more than two times.
AstraZeneca and its Liability
As with many other lawsuits against manufacturers of drugs, plaintiffs allege that AstraZeneca failed to conduct proper tests for side effects and appropriately warn healthcare providers and consumers about the potential health risks associated with Nexium and Prilosec.
While new warnings released by the FDA in correlation with a number of the studies mentioned above, both drugs continued to be marketed heavily by AstraZeneca, even to the point where there was an apparent shortage of the OTC version of Prilosec in the early 2000s.
As Prilosec was one of the best-selling drugs of AstraZeneca and accounted for several billions of dollars of revenue annually, the company continued to falsely advertise the drug’s effectiveness and safety. In 2002, when patent protection was lost, they continued with their deception by working to turn Prilosec consumers to their next generation drug, which was Nexium.
AstraZeneca marketed to consumers directly, claiming that Nexium – which had the same severe side effects as Prilosec – was more effective and safer than Prilosec. The company also allegedly bribed Medco, the health company, into advertising and discounting the newer medication in order to boost sales.
This resulted in AstraZeneca having to make a payment of a whopping 7.9 million dollars to the US Department of Justice for Nexium and Prilosec kickback scheme.
How Do You Qualify for a PPI Lawsuit?
If you have used Prilosec OTC, Nexium, Nexium 24HR, or Prilosec, and as result suffered serious side effects such as kidney damage, you stand eligible to file a claim against the manufacturer. It is extremely important to consult a Nexium lawyer or Prilosec lawyer soon after you sustain your injury so that you can receive a free case review and explore your options for filing a lawsuit.
With the help of an experienced lawyer, you can get the guidance you need to go through the whole claim process and make sure that you obtain the compensation you deserve for your injuries.
The majority of lawsuits involving Prilosec and Nexium, as well as claims against other similar medications for heartburn, are being handled through a process of multidistrict litigation. However, there are also several class action lawsuits that have been filed against AstraZeneca over injuries that PPI s such as Prilosec and Nexium have caused.
Prilosec, Nexium Class Action Lawsuit
AstraZeneca settled a class action lawsuit in 2015, which entailed Prilosec and Nexium, two of their popular heartburn medications. Along the same lines as the kickback scheme the company had with Medco, consumers claimed that the manufacturer was making attempts to boost sales of Nexium as their Prilosec patent ran out. The drugs are nearly chemically identical, but Nexium cost a lot more.
According to the class action lawsuit, a deceptive marketing strategy was created by the drug company to try and make Prilosec and Nexium “evergreen” and manipulate their own bottom line.
The case ended with a $20 million Prilosec lawsuit settlement that was paid out to the plaintiffs. Meanwhile, thousands of people have filed additional lawsuits against AstraZeneca and other manufacturers of PPIs in state and federal court over the severe side effects that are caused by these medications.
Proton Pump Inhibitor MDL 2789 Lawsuits
Several attempts were made to transfer these PPI lawsuits to a singular multidistrict litigation (MDL), which allows for a special federal process for streamlining and speeding up the handling of these cases. The US Judicial Panel on Multidistrict Litigation initially denied the motion to combine 39 federal lawsuits against a number of different manufacturers of PPIs into a single MDL in February 2017.
However, as the number of cases increased. The panel later reconsidered and MDL 2789 was officially formed in August 2017.
Judge Claire Cecchi and Judge Mark Falk are overseeing the Proton Pump MDL 2789 in the United States District Court of New Jersey. 161 cases were transferred when the MDL formed initially. As of May 2018, 4,248 lawsuits are pending and bellwether trials will be chosen and scheduled soon to begin the litigation process.
Contact a Lawyer Handling Nexium and Prilosec Lawsuits
If you or a loved one has suffered kidney damage or been diagnosed with chronic kidney disease, or other serious health issues, as a result of using PPIs like Prilosec or Nexium, you should contact a lawyer to discuss your options. After reviewing your case, your lawyer will help determine the best course of action, explain the entire legal process and protect your rights.
If the lawyer takes your case, they will attempt to make sure that the drug manufacturer is held legally liable for your injuries and damages, and that you receive fair, financial compensation for the ordeal you have gone through.
While you cannot go back in time and undo the devastating impact that the side effects of these medications have had on your life, you may be able to get compensation to help with medical bills and other expenses you incur as a result of the side effects associated with Nexium or Prilosec.
To contact a lawyer handling these lawsuits, please fill out the form below for a Free Case Evaluation.
Update: On July 20th, 2018, Bayer said that it will discontinue the sales of Essure in the United States at the end of the year. Something that patient advocates and injury lawyers have been working towards for many years after thousands of women have experienced serious health complications.
If you are wondering how to join the Essure lawsuit, skip to the bottom of this page to fill out the contact form for a Free Case Review.
Birth control, or contraception, is the deliberate prevention of pregnancy. The Centers for Disease Control and Prevention (CDC) reports that 15.9% of women in the United States are currently using the pill and 8% are using a contraceptive implant or intrauterine device (long-acting reversible contraception).
From 2011 to 2013, of the 60.9 million women aged 15 to 44 in the US, 61.7% were using contraception. The most common methods of contraception being used were contraceptive pills (16%), female sterilization (15.5%), long-acting reversible contraceptives (7.2%), and male condoms (9.4%).
Essure Birth Control Device
Essure is a permanent birth control device that consists of two small metal coils that prevent eggs from moving through the fallopian tubes when it is implanted. It thus prevents fertilization and implantation. Although it does not involve “tying” the fallopian tubes, it is technically a form of tubal ligation.
Patients Report Serious Side Effects From Essure
The contraceptive device is manufactured by Bayer Healthcare, the medical device-making giant. The company markets Essure as a “permanent contraceptive.”
Bayer claims that only a minimally invasive procedure is required for Essure devices and that the procedure can be performed right in a doctor’s office. However, women who receive the device must continue to use other birth control forms for a minimum for 3 months after insertion to confirm that it is effective and that it will prevent pregnancy.
Unfortunately, there are many people who have reported experiencing severe side effects and complications after implantation of Essure.
These issues include everything from allergic reactions and pelvic pain to needing additional surgeries for the removal of the device or repairing organs that have been damaged due to the birth control implant.
Side Effects and Complications of Essure
For many women, the side effects of the device started immediately after it was implanted. Some women have undergone several removal surgeries due to complications caused by Essure.
As of January 2018, there were 26,272 reports of adverse events for the device filed to the FDA.
Side effects mentioned:
Allergies to nickel
Severe pelvic pain
Rashes or itching
Chronic or severe pain
Unwanted or unintended pregnancy
Perforation of the colon, uterus or another organ
Breakage, migration or expulsion of the device
Is Essure Reversible or Removable?
According to the label of the contraceptive device, the Essure procedure is a permanent one and irreversible. However, in cases where women have experienced side effects, the coils of the Essure device can be surgically removed.
Why are Women Filing Lawsuits on Essure?
From late 2002 through late 2017, there were 26,773 complaints filed with the US Food and Drug Administration about Essure.
As a result, in April 2018, the agency restricted sales of the device. Bayer Healthcare announced in July 2018 that it would discontinue the sale of Essure in the US by December 31st, 2018.
There are more than 16,000 lawsuits for Essure that have been filed against the manufacturer. Plaintiffs claim that Bayer did not warn patients of the potentially severe complications. Many women are filing lawsuits against the manufacturer because of the numerous complications they experienced after implantation of the company’s birth control device.
FDA Actions and Adverse Events Timeline
Essure was originally approved as a Class III medical device in 2002 by the FDA. After the initial approval of the device, Bayer had to submit detailed reports related to not just the efficacy but also the safety of the device.
Bayer also had to submit any reports of adverse events, on a regular basis. Despite these requirements, the FDA cited the company a number of times for violations of those conditions, some of which resulted in the regulatory agency’s future actions:
June 2008: The FDA notified Bayer about a discovery it made about the company making Essure devices in an unlicensed factory at least since 2005, and that the medical device maker had failed to appropriately document their procedures.
January 2011: The FDA cited Bayer for using materials that were not approved in the Essure implant. This was a violation of the premarket approval, which required the manufacturer to seek additional approval for any changes in design.
February 2016: Bayer was ordered by the FDA to conduct a new clinical trial to determine whether Essure had any heightened risks for certain women, based on reports of adverse events that were filed to the regulatory agency.
November 2016: The FDA required the addition of a black box warning on the labels of the Essure device indicating the risks of allergy, abdominal pain, and the perforation, among other potential complications.
April 2018: The sales of Essure was restricted by the FDA to medical centers and doctors that promised to conduct a conversation and go through a checklist with the patient before they prescribed the birth control implant.
July 2018: The manufacturer of Bayer announced that they would discontinue selling the Essure birth control device by the end of the year, ultimately bowing to a lengthy campaign by health advocates and thousands of women to get the device off the market.
Will The Birth Control Lawsuits be Stopped by Preemption Laws?
Bayer Healthcare has made attempts to get a number of the Essure implant lawsuits dismissed as a result of certain laws that are known as preemption laws.
According to the company, it cannot be held liable for problems with the contraceptive device because the FDA conducts a rigorous series of tests on medical devices before approving them and deemed Essure to be generally safe.
There are a number of levels on which this argument is problematic, especially since it is clear that Bayer did not always follow its obligations on post-market regulations.
Nonetheless, using this argument, the company has succeeded in getting some product liability lawsuits dismissed while others have been allowed to move forward, with modified complaints in many cases.
If you have not contacted a lawyer to discuss your potential case, now is the time. Please do not wait, as you could be forever time-barred from pursuing an IUD lawsuit against the company.
Essure Litigation in Process
According to the most recent financial reports of Bayer Healthcare, approximately 16,100 lawsuits have been filed in state and federal courts across the US. At this time, all of these lawsuits are individual legal actions.
There are no current Essure class action lawsuits or any MDL (multidistrict litigation) processes that have been established. As of April 2018, a report from Bayer Healthcare stated that there were two lawsuits in Canada seeking class action certification.
Essure Multidistrict Litigation (MDL 2739)
A group of 28 plaintiffs had submitted a petition in 2016 to transfer their cases using the MDL process that was overseen by the Judicial Panel on Multidistrict Litigation. However, a short time after the petition was filed, a judge in the Eastern District of Pennsylvania – where 23 cases of the 28 had been filed – agreed to the consolidation of the cases in that court. The motion for a multidistrict litigation was withdrawn, resulting in the cases to remain separate.
In some cases, such as California, processes that use MDL system-like processes (called a JCCP) have been established to coordinate Essure cases. However, so far, there have been no efforts made so as to enforce a federal MDL.
There is a possibility of an MDL being created in the future due to the rise in the number of actions that are being filed.
Verdicts and Settlements in Essure Lawsuits
To this day, there have been no major publicized verdicts or settlements awarding large amounts of compensation to women who have been injured by the contraceptive devices. However, Bayer could decide to try to settle them due to a large number of lawsuits that are currently going through the court system.
This decision could come if it looks like the medical device maker is likely to lose cases based on the claims’ legal merits.
These suits are ongoing. Trials have not been set, so, as mentioned earlier, there are no jury verdicts or settlements. Lawsuits in California may be the first to go to trial. Jury verdicts from the first cases may have an influence on jury verdicts in other states.
In May 2018, both sides were ordered to name Special Settlement Masters by Judge John R. Padova in Pennsylvania in the event of a settlement. Special Settlement Masters is a firm that handles any potential settlement in lawsuits.
Potential compensation may result from damages that include:
Pain and suffering
Lost time from work
Loss of income
Loss of quality of life
Loss of companionship
Status of Essure Litigation
Women and their families continue to file claims in state courts across the United States. Most of the lawsuits are in Pennsylvania, California, North Carolina, and Missouri. In February and April 2018, the latest Essure lawsuits were filed by plaintiffs in Pennsylvania federal court.
Women who filed in Pennsylvania said that the device migrates from the fallopian tubes, breaks into pieces, perforates organs, and/or corrodes and wreaks havoc on the female body.
In March 2018, Judge Winifred Y. Smith of California made it mandatory for plaintiffs to submit a master complaint in which allegations against Bayer should be combined. She also stated that both parties should begin their preparations for trial. As of March 2018, Judge Smith presided over more than 13,000 California lawsuits on Essure.
Essure Cases that have been Dismissed
There have been some judges that have dismissed Essure cases for preemption. This puts a limit on product liability in state lawsuits after approval from the FDA. As mentioned earlier, Judge Smith permitted some of the lawsuits in California to proceed in spite of preemption.
Other cases have been dismissed for failing to meet the requirements of the court. For example, in January 2018, Judge Stephen Lambaugh of Missouri federal court threw 92 out of 95 plaintiffs from an Essure case.
IMPORTANT: Just because some cases have been dismissed does not mean that you are out of luck. Regardless of which state you live in, if you have been injured by Essure, you have legal rights and can still contact an Essure lawyer to discuss filing a case.
Filing an Essure Lawsuit
To file a lawsuit against Bayer, the first thing you need to do is contact a lawyer with experience in product liability cases and lawsuits. You should arrange a phone conference to discuss your complications and learn more about their law firm.
Most lawyers will conduct a review of your potential case for free.
Once the free case evaluation is done, your lawyer will let you know if they are interested in moving forward with your claim.
You will not have to pay an Essure lawyer for their services if they take on your case as they usually work on a contingency basis. This means that you will not pay anything unless there is a jury verdict or settlement to your benefit. When you obtain compensation from the lawsuit, your lawyer will receive a negotiated amount for fees and expenses.
Time Limits for Filing a Claim
Only a lawyer can determine the statute of limitations, or time limit, for filing each Essure case. The statute of limitations varies from state to state
Your lawyer will find out the time limit in your state and make sure that you file your case before that time limit. It is important to file your claim before the statute of limitations ends or you might lose your right to pursue future action.
If you haven’t already, you should contact an Essure injury lawyer immediately to discuss your defective medical device case.
Get Legal Assistance – Contact an Essure Lawyer
If you or a loved one has experienced side effects or suffered complications as a result of the Essure birth control device, you should immediately seek the help of a qualified lawyer.
To speak with a lawyer handling Essure lawsuits, please fill out the form below. Our lawyers respond to each and every email they receive in a timely manner.
It is likely that the actual number is a lot higher as many of the doctors who do perform genital reconstructive surgery are gynecologists and obstetricians and these statistics are not recorded or tabulated by any agency or even the American College of Obstetricians and Gynecologists. On top of this, with tax cuts and a fantastic economy in 2018, these types of surgeries are probably even more prevalent.
Laser Vaginal Rejuvenation Institute of Los Angeles founder and director, Dr. David L. Matlock says that he has performed over 3,000 of these surgical procedures in the past 12 years.
The term “vaginal rejuvenation” covers a number of different types of surgery. It is also often referred to as a kind of female genital plastic surgery, vulvovaginal plastic surgery, female genital rejuvenation surgery, designer vagina surgery, and female genital cosmetic surgery.
Among the surgical procedures comprising female genital plastic surgery are vaginoplasty, labiaplasty, monsplasty, labia majoraplasty, and clitoral hood reduction.
This type of surgery is advertised for women who experience tightness or looseness of the vagina, urinary incontinence, dryness, or pain during sexual intercourse. Surgeons use radio frequency waves, lasers, cryotherapy, or other devices to tighten the tissues of the vagina.
In recent years, a number of companies have developed devices for vaginal rejuvenation. Most devices use lasers or radiofrequency to make it possible for surgeons to perform minimally or non-invasive procedures to tighten or rejuvenate female genital parts.
The problem is that these devices have not been FDA-approved for these procedures and federal law prohibits companies that manufacture medical devices from marketing their products for purposes that are unapproved.
In addition, a large number of women have come forward and reported side effects or complications arising from vaginal rejuvenation surgical procedures.
Potential Side Effects of Vaginal Rejuvenation
Side effects of vaginal rejuvenation surgery include the following:
Numbness or loss of sensation
Pain with sexual intercourse
Significant chronic pain
A lot of women are opening the door for vaginal rejuvenation, especially those who have gone through the rigors of childbirth.
Although it is primarily thought of as an aesthetic type of surgery to improve the female genital area’s appearance, there are a number of sound medical reasons to press the button for vaginal rejuvenation, such as SUI, irritation of the labia minora or labia majora, better access to the clitoris, or weakness in the perineum.
It should be noted that this procedure is not recommended to treat female sexual dysfunction or sexual problems.
As with any type of surgical procedure, there are potential side effects that could have an impact on the decision of whether or not vaginal rejuvenation surgery is the best choice for optimal health.
Nerve Damage: The genital area of the female body is replete with nerve endings. Nerves can be damaged or severed during surgical procedures like vaginal rejuvenation, resulting in too much sensation, also called hyper sensation, or a lack of sensation, also known as hypo sensation. Because nerves do not usually regenerate, this side effect is permanent.
There is no surgeon who can guarantee that this will not occur. This is why it is important to consider the risk before deciding whether or not to undergo the surgery.
Scarring: The goal of most vaginal rejuvenation surgeries is an improved genital appearance. Scarring from this type of surgical procedure will be internal, but it will be there. This could result in a loss of sensation or dead spots. On top of this, if the scarring is severe, additional surgery could be required.
Urine Retention, Rectal, or Bladder Damage: The inability to urinate, or urinary retention, is a possible side effect of vaginal rejuvenation surgery. This can result in serious health issues such as damage to the kidney, or nephrosis, and immediate attention will be necessary to correct it. Not only this, this type of procedure can damage the bladder or rectum, although such instances are not common.
Any surgery comes with risks. However, you can minimize the chances by conducting thorough research on the surgeon you choose, making sure that you pick one with experience in performing this type of surgery.
Bleeding and Infection: Because of where the surgery is performed, infections can occur if the patient does not maintain proper hygiene.
For anywhere between 4 to 8 weeks, limitations will be put on lifting and activities to help in preventing excessive post-surgical bleeding. It is also required for patients to abstain from sex during this period in order to make a full recovery. It is imperative to follow the doctor’s instructions for a healthful healing.
Vaginal rejuvenation is a relatively new type of surgery, and it has been stated by the American College of Obstetrics and Gynecology that adequate studies have not been conducted to date to assess the procedures’ long-term safety and rates of complications.
Whether performed from medical necessity or elective, any surgical procedure carries risks for complications or side effects. It is critical to remember that you must choose the surgeon who performs the surgery carefully and make sure to follow the instructions regarding care before and after the procedure for the best results.
Three Primary Laser Platforms
One of the hottest topics in urology nowadays is women’s health and vaginal health in particular. The laser vaginal rejuvenation world is a fast-paced one, with companies coming up with a new laser platform nearly every month. These latest treatments provide urologists many potential opportunities as well as challenges.
When assessing the laser vaginal rejuvenation market, it is important for urologists to form their research around treatment indications as well as the proposed laser mechanism of action. At present, there are three basic categories that are used for this purpose: CO2, radio frequency (RF), and erbium:YAG (Er:YAG).
CO2: This is a fractionated laser that operates at a wavelength of 10,600 nm. This is a relatively short wavelength that allows for more superficial supervision of the tissue. Genitourinary syndrome of menopause (GSM) is the most common indication for laser vaginal therapy, although companies are also touting efficacy in the treatment of stress urinary incontinence (SUI). CO2 can also be used on the vulva and as a treatment for lichen sclerosis (LS).
Radiofrequency (RF): This is a laser that generally penetrates tissue more deeply, which is why it is indicated for vaginal laxity. With radio frequency, the frequency is lower while the wavelength is relatively longer, allowing for deep tissue heating. There are also a number of RF platforms that treat GSM. On the other hand, some platforms advertise for SUI treatment with a combination of internal and external applicators.
Erbium: Er:YAG is ablative, operating at 2,940 nm. This technology is used in different platforms alone or in combination with a diode that operates at 1,470 nm – this is known as a hybrid fractional laser. Er.YAG’s proposed action of mechanism is similar to CO2 in that it stimulates neocollagenesis. The controlled thermal injury also leads to angiogenesis. This platform carries the same indications as CO2 and is currently being marketed for GMS, SUI, and LS.
Vaginal Rejuvenation Procedure
All of the laser platforms can be used in a doctor’s office or clinic. A topical anesthetic is typically applied to the area that needs to be treated for 10 to 20 minutes.
The medical professional applies the laser energy internally to the vagina’s epithelium through probes or externally with adaptors. Treatments take anywhere between 5 and 10 minutes. The total time of your office visit will be 30 to 45 minutes.
Between 3 and 5 treatment sessions spaced 4 to 6 weeks apart are suggested for most platforms to get optimal results. Following the procedure, you do not need to worry about downtime.
Contraindications for the procedures include active urinary tract or vaginal infection, active genitourinary cancer, undiagnosed cervical or vaginal lesions, and pregnancy, including 3 months after pregnancy. A relative contraindication is pelvic organ prolapse that is greater than stage II. Experts do not recommend the therapy for women who have had mesh prolapse surgery in the past.
Depending on the specific procedure that the patient chooses, the cost of vaginal rejuvenation can range from $4,000 to $10,000.
This type of surgery is considered a cosmetic surgery by most insurance companies, which is why they do not offer coverage. However, in cases where vaginal rejuvenation surgery is performed to correct a medical condition that is legitimately covered, the patient may be eligible for cost reductions.
Avoiding Vaginal Rejuvenation Surgery
With stories popping in magazines and all over the Internet, vaginal rejuvenation is becoming a common cosmetic surgical procedure. What you may not know is that even though it is considered cosmetic surgery, it is still surgery and a lot more invasive than people are made to believe.
Vaginal rejuvenation should be considered as a last resort, like any other type of surgery. The fact that a laser is used to perform the procedure gives the impression that it is non-invasive and perfectly safe. However, as mentioned already, it does not come without risks.
If you need the results provided by laser vaginal rejuvenation, it is important to keep in mind that there may be safer options that cost less and do not come with the risk of complications or side effects. There are creams available on the market to tighten the vagina as well as improve dryness in the vaginal area and increase libido and sexual pleasure. You may be able to achieve these results without surgery.
FDA Warnings About Laser devices for Vaginal Rejuvenation
The FDA initially approved for lasers and other similar energy-based devices to be put out into the market to treat life-threatening conditions, such as cancer and genital warts, or surgical procedures including hysterectomies.
Lasers and other energy-based devices are not approved for any type of procedure for vaginal rejuvenation. Companies are prohibited by federal law from marketing medical devices for purposes that are unapproved.
However, in the last few years, several companies that manufacture these kinds of devices have left no stone unturned in heavily promoting the use of lasers for symptoms that are related to menopause, vaginal atrophy, sexual function and urinary incontinence.
On top of this, lasers and other products used for vaginal health in cosmetic, spa treatments have become increasingly common and very popular among younger women.
These devices are used in some treatments to reshape or destroy vaginal tissue. The companies manufacturing these devices say that they can solve some problems that are related to dryness and other issues. The FDA does not agree. However, although the agency originally approved the devices only for certain treatments, doctors can legally use them for off-label conditions.
In July 2018, the FDA issued a Safety Communication to warn that there are serious safety risks associated with vaginal rejuvenation. Furthermore, it added that the devices are being deceptively marketed for uses that have not been approved by the agency.
The FDA also stated that there are concerns about the deceptive marketing of these devices and how it could prevent some patients from receiving appropriate treatment for the serious medical conditions that they suffer from.
The agency said that the full extent of the risks is still not known, but has found cases, scarring, vaginal burns, long-lasting pain and other side effects that have been mentioned earlier following the treatments. 14 reports of adverse events that are related to vaginal rejuvenation treatments 1 have been received by the FDA, including significant pain and burning sensations.
Companies Warned By the FDA
The FDA is warning doctors and women that devices available on the market that purport to make cosmetic vaginal alterations have not been approved by regulators for that purpose and could lead to painful and dangerous side effects.
The agency has issued warnings to seven companies stating that their radiofrequency- or laser-based products are being marketed inappropriately as providing “vaginal rejuvenation” procedures.
The companies have made claims that the devices have the ability to tighten the vagina or treat symptoms of conditions that have already been mentioned above.
The FDA has also received reports of incidences in which companies are marketing the devices to women who are having signs of early menopause and have been treated for breast cancer. The agency stated that it is egregious to deceptively market a dangerous procedure without any proven benefit, including two women who have received treatment for cancer.
The FDA has not approved any non-surgical devices on the market to treat any of these conditions. Instead, as mentioned earlier, they have been approved to destroy precancerous vaginal or cervical tissue as well as genital warts.
The agency has found that when the devices are used outside of their approved purpose, they have resulted in pain during urination or sex, burning of the vagina, and scarring. They said that they were deeply concerned about women being harmed by these devices.
The companies that the FDA issued warnings to include:
They were given 30 days to respond to the concerns of the agency.
If they fail to do so, then the FDA will take other measures, which could include asking the manufacturers to remove devices from the market entirely. The agency is also asking the public to report any incidents that they have had while using the devices.
The letters issued to laser device manufacturers are considered a step short of a formal warning. The agency asked the companies to provide details on their product and the basis on which they are assuming approval.
There has been a lot of pressure on the FDA to speed up the approval of medical devices. According to critics, device approvals by the agency are already moving at an extremely fast pace and occurring with insufficient oversight. In its announcement, the agency said that they would strengthen their device studies after being approved for sale.
The American College of Obstetricians and Gynecologists has also issued several statements that note that the MonaLisa Touch and other devices do not have clearance or approval from the FDA for treating symptoms of menopause, as advertised.
The college said that obstetrician-gynecologists should be aware of the evidence when it comes to the use of new and innovative practices and should also be wary of adopting any medical approaches that are “new and innovative” on the basis of just marketing or promotions.
Claims Made by Vaginal Rejuvenation Device Manufacturers
As mentioned above, the FDA has contacted several companies that manufacture and sell laser and radiofrequency devices for rejuvenation purposes.
The sole intention of agencies such as the Women’s Health Technologies Strategically Coordinated Registry Network is to help in addressing and bringing to light the lack of evidence into the treatment of pelvic floor disorders and other conditions.
Despite their lack of approval from the FDA, manufacturers are actively marketing their devices for treating symptoms related to menopause. Cynosure’s website says that its product, the MonaLisa Touch is a clinically proven laser treatment that is simple and safe and ideal for painful menopause-related symptoms, including intimacy.
Alma Lasers, another company that the FDA has warned, states in its website that its product, the FEMILIFT, is a laser-assisted procedure uses a CO2 laser to provide vaporization and thermal effect to help in improving vaginal irregularities.
All of these claims and more are questioned in the letters by the FDA.
A medical aesthetics division of Hologic, Cynosure said that the company was aware of the FDA letter and ensured that they were taking the contents seriously. It stated that they are evaluating the letter in full and will work with the FDA to make sure that all product communications adhere to regulatory requirements.
Lawsuits Against Manufacturers of Devices for Performing Vaginal Rejuvenation
Unfortunately, vaginal cosmetic surgery, including vaginal rejuvenation, is growing in popularity among women all over the world. The pressure to look “perfect” in every way has pushed many women, including young girls, to opt for vaginal rejuvenation surgery.
What is even more unfortunate is that a large number of the women who have undergone this type of procedure have suffered from complications or side effects resulting from the treatment.
The truth is that the deceptive marketing of the devices is the main cause of the side effects and complications suffered by women who have undergone vaginal rejuvenation. As mentioned already, the manufacturers claim that their devices are safe and effective for this type of surgery regardless of not being approved by the FDA for these purposes.
Only a qualified lawyer can determine whether you are eligible to file a lawsuit against a manufacturer of a laser used for vaginal rejuvenation treatment. Only a few law firms are currently investigating the filing of lawsuits for women who have undergone this type of surgery and suffered complications or side effects as a result.
In most cases that involve medical devices, it is alleged that a product was sold with defects in its design, manufacture or marketing process. This typically refers to the failure of a company to warn medical professionals and patients of a certain potential complication.
In lawsuits involving vaginal rejuvenation, patients may be able to take legal action against the manufacturers of these types of devices in light of claims that they failed to adequately warn doctors as well as patients about the risk of scarring, vaginal burns, and other serious side effects.
Contact a Lawyer For a Free Vaginal Rejuvenation Lawsuit Review
If you or a loved one has suffered from side effects or complications caused by a vaginal rejuvenation procedure, you should immediately seek the help of a lawyer to help you file a lawsuit against the manufacturer of the device used in the surgery.
The lawyers who work with Advocacy For Patients™ will evaluate your potential case for FREE to determine if you have a viable case against the company.
Contact a vaginal rejuvenation lawyer for a free case evaluation using the form below.