If you or a loved one has been injured by Essure, you are not alone. To read more about the Essure lawsuit, please click the link below. We hope the infographic is helpful to you in your research.
ESSURE LAWSUIT UPDATE: Bayer recently said that it will discontinue the sales of its extremely controversial birth-control device in the United States at the end of 2018, bringing to a close a battle between the giant pharmaceutical company and patient advocates and lawyers over an implant that thousands of women blame for serious health problems.
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 that were currently 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 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.
The contraceptive device is manufactured by Bayer Healthcare, the medical device-making giant. The company markets Essure as a “permanent contraceptive.” The same was said by the device’s previous company, Conceptus Inc., which was bought by Bayer in 2013.
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.
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.
Common Side Effects and Complications of Essure
The most common side effects and complications of Essure include the following:
- Rashes or itching
- Hair loss
- Migraine headaches
- Menstruation problems
- Weight gain
- Back pain
- Brain fog
- Metal allergies
- Chronic fatigue
- Chronic or severe pain
- Scar tissue
- Unwanted or unintended pregnancy
- Ectopic pregnancy
- Autoimmune disorders
- Perforation of the colon, uterus or another organ
- Fetal death
- Breakage, migration or expulsion of the device
- Additional surgeries
Is Essure Reversible or Removable?
According to the label of the contraceptive device, the Essure procedure is a permanent one and irreversible. While some claims have been made about successful removal of the birth control device and restoration of fertility, the procedure for Essure implantation remains untested in a reliable clinical trial or other methods that can be scientifically verified.
In cases where women have experienced side effects, the coils of the Essure device can be surgically removed. However, the device’s effects are not guaranteed to be reversed. They may require additional surgeries, especially if the device breaks apart, or if there is the formation of scar tissue or perforation of an organ.
Why are Women Filing Essure Lawsuits?
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 permanent birth control devices in the US by December 31st, 2018.
There are more than 16,000 lawsuits that have been filed against Essure. 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 that they went through after an implantation of the company’s sterilization device.
These complaints range from minor to major problems resulting from the breaking of the devices, device migration, and in some cases, even expulsion of the implant.
As part of the complaint, a large number of women are seeking damages for medical care costs to treat symptoms and complications caused by the contraceptive implant’s malfunction as well as related expenses.
There are many women who are also seeking non-economic damages that are related to physical pain and emotional as well as mental anguish. These patients are also expecting to receive punitive damages. If successful, this will allow them to “punish” Bayer Healthcare for the development, manufacture, and promotion of an unsafe medical device.
Apart from the failure to warn of side effects, Essure lawsuits allege that Bayer lied to the FDA in order to get approval for the device. They also say that the company failed to train doctors properly on how to use Essure.
Bayer attempted to blame physicians, using the term “learned intermediary doctrine” to say that it is the responsibility of the doctor to warn women about the potential risks and complications that come with Essure birth control implants.
The allegations in Essure lawsuits against Bayer include:
- Failing to report and actively concealing adverse events of the device
- Manufacturing the device without a license for 3 years
- Failing to have a complete risk analysis for the birth control device
- Failing to track complications caused by Essure
- Failing to disclose 16,047 medical device complaints of suspected malfunction of Essure to the FDA
- Distributing Essure equipment for sale to physicians who are unqualified
- Encouraging physicians to “sell” the device to patients
- Failing to properly train physicians on how to use the birth control device
Side Effects Mentioned in Essure Lawsuits
There are several side effects mentioned in Essure lawsuits. For many women, the side effects of the device started immediately after it was implanted. Some women underwent several 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. Doctors have seen a decline in the demand for Essure due to the lawsuits filed by women injured by the device.
Side effects mentioned in Essure lawsuits include the following:
- Allergies to nickel
- Heavy periods
- Severe pelvic pain
These are in addition to the side effects mentioned earlier.
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 peroration, 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.
Will Essure Lawsuits be Stopped by Preemption Laws?
Bayer Healthcare has made attempts to get many Essure 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.
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 lawsuit 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 for the Essure lawsuits. 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 in Essure lawsuits 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 the 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.
In recent years, there have been reports from some outlets that Bayer lost $413 million as a result of legal issues with Essure. This estimation comes from the financial records of the corporation, which claimed “impairment losses” of €391 million related to “intangible assets” that were connected to the birth control device.
The latest annual report does not list any kind of impairment losses individually for this device but does tabulate that €258 million (roughly $308 million) was incurred by the company in “expenses related to significant legal risks” for its products including Essure, Avelox, Cipro, and Xarelto.
There should be no confusion between losses noted on corporate financial statements and compensation paid to women injured by Essure. Based on the amount of money that Bayer is willing to spend in defense against personal injury and product liability claims, it is clear that the medical device manufacturer thinks that losing such cases could lead to much higher losses for victims of the defective birth control devices.
Essure lawsuits 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 Essure lawsuits 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 from Essure lawsuits will result from damages that include:
- Medical bills
- Pain and suffering
- Lost time from work
- Loss of income
- Loss of quality of life
- Loss of companionship
Status of Essure Lawsuits
Women and their families continue to file Essure lawsuits 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 Essure lawsuits 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 Essure lawsuits.
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 Essure lawsuits in California to proceed in spite of preemption.
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 file an Essure lawsuit.
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.
Filing an Essure Lawsuit
To file an Essure lawsuit, the first thing you need to do is contact a lawyer with experience in product liability cases and handling lawsuits against major companies like Bayer Healthcare. You should arrange a meeting and provide the lawyer with all your medical records and other documents to present as evidence in your Essure case.
The lawyer will then review your case to determine whether there is sufficient viable evidence to file a lawsuit against Bayer for side effects or a complication caused by the birth control device. Most Essure lawyers will conduct a review of your case for free.
Once the free case evaluation is done, your lawyer will inform you if you can file an Essure lawsuit. If so, they will begin to prepare your case and take the necessary steps to file the claim against the manufacturer of the device.
Keep in mind that lawsuits against large corporations like Bayer can be extremely challenging as they have high-power lawyers defending them against any legal action taken against them. It will be an arduous, complex process that could take a long period of time, even years, to conclude.
Once your lawyer begins the process of filing an Essure lawsuit, they will do everything required to prove your case in court. They will collect all the evidence needed and also get expert witnesses to testify that your injuries were caused by the implantation of the birth control device.
It is important to prove to the jury that you were harmed by Essure to obtain a favorable outcome. It is also critical to make sure that the proper steps are taken to file your Essure lawsuit and prevent your case from being tossed out by a judge. This is why you need to hire a skilled and experienced lawyer who has handled cases like this prior to yours.
If your case is a strong one, it is a possibility that Bayer’s lawyers might approach you and offer a settlement.
You and your lawyer should discuss matters properly before making any decision. If you think that you have a strong case and can get a larger amount of compensation from a jury verdict, you can turn them down and continue with the trial.
Your attorney is the best person to advise you as they have the knowledge and experience to tell when to accept a settlement and when to continue fighting in court. They have your best interest in mind and will make sure that your rights are protected, and that the company does not take advantage of you.
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 your award from the Essure lawsuit, your lawyer will receive a negotiated amount for fees and expenses.
Time Limit for Filing an Essure Lawsuit
An Essure 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 Essure lawsuit before that time limit. It is important to file your claim before the statute of limitations ends or your case will be thrown out by the judge immediately.
Women have 2 to 3 years to file an Essure lawsuit in some states. If someone died due to the contraceptive device, families generally have about 2 years to file an Essure lawsuit for wrongful death.
However, in some states like California, the time limit to file a lawsuit against Essure may only be one year and in other states, it could be more. You should contact an Essure lawyer immediately to find out your eligibility to file the lawsuit against the device manufacturer.
Please contact an experienced product liability lawyer handling Essure lawsuits to learn more about the statute of limitations in your state.
Get Legal Assistance for Essure Lawsuits
If you or a loved one has experienced side effects or suffered complications as a result of an Essure birth control device, you should immediately seek the help of a dedicated Essure lawyer.
You can file a lawsuit against the manufacturer of the device for compensation for the injury and damage you have gone through after receiving the birth control implant. Depending on the circumstances, you can be awarded a jury verdict or get a settlement offer from the company.
You can file an Essure lawsuit for damages including medical bills for present and future medical treatments, pain and suffering, loss of income, loss of quality of life, punitive damages and more. In wrongful death cases, damages can include medical bills, loss of income, loss of benefits, loss of consortium, survivors’ pain and suffering, and punitive damages.
With the help of an accomplished product liability lawyer experienced in handling birth control lawsuits, you can make sure that you receive the compensation you deserve for the harm caused by Essure side effects and that you are legally entitled to.
The American Society of Aesthetic Plastic Surgery reported that in 3,494 vaginal rejuvenation surgeries were performed in 2008 while 2,531 were performed in 2009.
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.
Excellent Additional Reading Material:
- Women Are ‘Duped’ in Quest for Perfect Vagina, Says Doctor (ABC News)
- Designer Parts: Inside the Strange, Fascinating World of Vaginoplasty (The Atlantic)
What is Vaginal Rejuvenation?
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 US Food and Drug Administration (FDA) announced that it has issued warnings to several companies to put an end to marketing laser devices for procedures that are billed as “vaginal rejuvenation.” They said that these procedures were treatments that are dangerous and deceptive.
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:
- Alma Lasers,
- BTL Industries,
- BTL Aesthetics,
- Thermigen, and
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.
Approved in 1996 by the US Food and Drug Administration (FDA), Taxotere, also called docetaxel, is a well-known anti-mitotic chemotherapy medication. It is a part of the taxane family; which work to slow down the growth of cells in the body.
Since its approval, Taxotere has been used to treat a wide range of cancers, including gastric cancer, hormone-refractory prostate cancer, head and neck cancer, non small-cell lung cancer, and advanced or metastatic breast cancer.
Although the drug is approved for use as a single agent, it can also be used with other chemotherapeutic medications. Taxotere is typically administered by injecting it into the patient’s vein in one-hour sessions every 3 weeks.
Taxotere Complications: Taxane Side Effects
Since anti-mitotic drugs and taxanes are unable to distinguish between healthy or cancerous cells, any drug that inhibits the division of cells will have serious side effects.
So while taxanes stop the division of cells in harmful tumor cells, they also kill healthy cells like bone marrow, hair follicles, and other germ cells. In most cases, the side effects that patients experience dissipate after the end of the treatment, but they may also be permanent in some cases.
Taxotere Adverse Effects and Complications
Although most taxanes come with the same side effects, there are unique side effects that only Taxotere has – its competitor drugs do not. In most cases, people do not experience all of the side effects of this medication but will experience some.
The side effects of Taxotere may vary based on the dosage. If the drug is taken in high doses, the side effects will be more severe.
The packaging of Taxotere has classified possible side effects into the following categories:
- Allergic Reactions (affects roughly 1 in 10 patients):
- Fever or chills
- Itching, flushing skin reactions
- Low blood pressure
- Back pain
- Difficulty breathing, tightness of the chest
- More severe reactions
Very Common Side Effects (affects more than 1 in 10 patients):
- Loss of appetite (anorexia)
- Joint pain
- Sores in mouth
- Bleeding from nose
- Alteration in sense of taste
- Infections – reduced number of red or white blood cells (required to fight infection) and platelets
- Excessive tearing or inflammation of the eye
- Nausea, vomiting
- Indigestion – including constipation and diarrhea
- Abdominal pain
- Muscle aches and pains
- Short-term hair loss (this can be permanent with Taxotere)
Other Taxotere side effects and complications are also listed on the label under the “Very Common” classification.
These side effects are common and frequent during treatment. Health care professionals advise patients not to eat before treatment in order to relieve nausea and suggest eating small meals throughout the day to control nausea and vomiting.
Common Side Effects (affects less than 1 in 10, but more than 1 in 100 patients):
- Loss of hearing
- Oral candidiasis
- Decrease in blood pressure
- Heart failure
- Raised liver enzymes
Uncommon Side Effects (experienced in less than 1 in 10, but over 1 in 100 patients):
- Phlebitis (infection at injection site)
- Inflammation of the small intestine (intestinal perforation), colon
Taxotere Hair Loss Side Effect: Permanent Alopecia
While the side effects and complications of Taxotere generally subside after treatment is discontinued, there is one side effect that is known to be a permanent one.
A study in 2012 showed that in all cases where patients suffered permanent hair loss following chemotherapy, Taxotere or docetaxel was involved. According to the study, alopecia, or hair loss, induced by chemotherapy is one of the most troublesome and distressing side effects of the treatment, along with fatigue, nausea, and vomiting.
It may have a significant effect on the self-image of an individual and research has found that patients experience low self-esteem and anxiety.
Despite the phrase, “in most cases, hair growth should return”, Taxotere does not mention permanent hair loss in their list of possible side effects. However, it is too late for many patients who have used the drug for their chemotherapy. This permanent side effect is irreversible and includes eyelashes and eyebrows in addition to the hair on the head.
It is known that hair loss is a common side effect of chemotherapy since a lot of different types of the drugs are used in the treatment to kill fast-growing cancer cells.
Although hair loss is often expected in patients who undergo chemotherapy, alopecia or permanent hair loss is not. In most cases, patients’ hair usually begins growing back within 3 to 6 months after the completion of the treatment.
While breast cancer patients who were prescribed Taxotere were warned about the potential hair loss that might come with the drug, Taxotere lawsuits state that Sanofi-Aventis US LLC, the manufacturer of the drug, did not adequately warn patients about the high risk of permanent hair loss.
According to research, even when cancer patients are prepared for the hair loss they may experience, it is still a very traumatic experience. Studies have found that on average, 6% to 9% of patients of breast cancer had to deal with permanent alopecia, thereby having to cope with other negative setbacks in their personal lives.
A small study observed 20 breast cancer patients’ quality of life after being treated with Taxotere and experiencing permanent hair loss. Despite undergoing treatments to help in stimulating hair growth, patients and oncologists saw that only a handful of patients saw a very slight improvement in their condition.
As a result, 40% of the patients said that their quality of life was extremely poor, and 70% choose to wear a scarf or wig to hide their alopecia – this is only logical.
Although Taxotere has been on the market for a number of decades now, it was not until more recently that Sanofi began to face a growing number of lawsuits by patients and survivors of breast cancer as a result of false marketing and the treatment’s severe side effects.
As of the most recent report, the pharmaceutical company is facing 7,820 pending lawsuits. The latest update from the US District Court for the Eastern District of Louisiana states that the first Taxotere bellwether trial will begin in January of 2019.
Allegations Against Manufacturers of Taxotere
In lawsuits filed against Sanofi by women and families, it is alleged that the pharmaceutical giant was aware of the link between the use of Taxotere and permanent hair loss and failed to warn patients.
According to the lawsuits, Sanofi also marketed Taxotere as more effective than other drugs used in chemotherapy when they were equally effective without the associated permanent loss of hair.
Taxotere lawsuits accuse Sanofi of:
- Not testing Taxotere properly before selling it
- Failing to determine whether or not the drug was safe
- Selling the drug without disclosing the risks or dangers
- Failing to provide proper warning to health care providers and patients
- Misleading the public in marketing and advertising
- Concealing information from the public
- Manufacturing a dangerous drug
- Downplaying the dangers and risks associated with Taxotere
Lawsuits Say Sanofi Concealed Information About Hair Loss Side Effects
According to lawsuits, Sanofi misled the public by giving them false reassurance that hair would grow back after stopping chemotherapy. But the company should have had knowledge that there was a higher rate of permanent alopecia in their drug than similar drugs on the market.
Studies that Sanofi should have been aware of include the following:
1998: Sanofi sponsored a study that was named GEICAM 9805. The company knew by 2005 that this trial’s results revealed that 9.2% of women who used Taxotere suffered permanent alopecia.
2006: The Rocky Mountain Cancer Centers’ Dr. Scot Sedlacek conducted a study that showed that Taxotere could cause over 6% of women to suffer permanent hair loss.
Despite informing patients in other countries, Sanofi failed to warn women in the United States of this risk for years.
Lawsuits say that the words “alopecia” or “permanent hair loss” did not appear in any information that was published in the US.
Accusations of Promoting Sales at the Expense of Patients
Taxotere lawsuits question Sanofi’s motives since the initial FDA approval of the drug in 1996. They say that the company downplayed the drug’s risks and trained employees to misrepresent its effectiveness and safety.
According to a lawsuit filed by one of the former employees of Sanofi in 2015, the company engaged in illegal “kickback” payments to health care professionals to prescribe Taxotere. Lawsuits say that the misconduct resulted in soaring sales of the drug.
It is claimed that Taxotere’s sales went up from $424 million in 2000 to $1.4 billion in 2004 through illegal payment of kickbacks and misrepresentation.
In her complaint, one woman wrote that one of the most vulnerable groups of individuals were preyed upon by the defendants at the most difficult time of their lives and that the defendants obtained increased revenues of billions of dollars at the expense of cancer patients who were unwary and simply hoping to survive their condition and begin living a normal life once more.
Manufacturers of Taxotere Facing Lawsuits
The drug companies that are named in Taxotere lawsuits are Sanofi SA, Sanofi-Aventis US LLC and Aventis Pharma SA. These companies were involved in the design, development, manufacture, distribution, labeling, marketing, advertisement, promotion, and sales of Taxotere.
In 2009, before Sanofi lost patent protection, Taxotere made more than $3 billion for the company.
Taxotere is prescribed by doctors to treat the majority of cases of breast cancer in the United States, and approximately 300,000 women are diagnosed with the cancer each year. It is also the most prescribed drug in its class.
Taxotere Class Action
There are no class action lawsuits at present over claims that Taxotere results in permanent hair loss. Three women filed a Taxotere class action lawsuit in December 2016. In April of the following year, the women asked the court to certify the class.
This step is necessary in order for the class action to proceed. A judge denied the request for class action certification in July 2017.
According to the court order that denied class action certification, the cases had too many differences for them to be considered a class. Differences surrounding the claims that were denied class action certification include:
- Whether the patients were administered brand name Taxotere or a generic equivalent
- What combination of chemotherapy agents was used in connection with the drug or its generic equivalent
- The Taxotere or generic equivalent dosage that was administered
- The number of cycles of treatment that took place
- The description of the alleged injury
- The damages that were sought by the plaintiffs
Studies Reveal that Alopecia Leads to a Diminished Quality of Life
Hair loss ranks as one of the most distressing cancer treatment side effects consistently and has a profound effect on the patient’s well-being and quality of life.
In some studies, about 9% of patients of breast cancer suffered alopecia that lasted for 10 years or more, negatively affecting body image, severely decreasing their quality of life and causing distress and depression.
In 2008, Lemieux et al. published a review of 38 articles that analyzed the impact of hair loss on breast cancer patients. Authors of the study looked at the quality of life that related to body image, distress, anxiety, self-esteem, social functioning, sexuality, and the ability to return to work.
In 2012, Klugel et al. published a study in the Annals of Oncology following 20 patients who used Taxotere as part of their cancer therapy. All of the 20 patients suffered permanent hair loss after being treated with the drug. Despite various treatments for alopecia, the women were left with clumpy, sparse, and incomplete hair regrowth.
About 40% of these women showed scores indicating “severe impairment” of quality of life.
One of the women in the study said that she would have preferred not receiving any chemotherapy for her breast cancer rather than experiencing such a distressing and permanent side effect. About 70% of the women who participated in this study wore wigs or scarves to cover their heads – as already somewhat indicated.
Taxotere Lawsuits – Speak With a Taxotere Lawyer
If you or somebody you know took Taxotere and developed permanent hair loss, you may be entitled to compensation for your injuries, pain, and suffering. Contact a Taxotere lawyer by using the form below.
Increased Risk of Amputation With Invokana Diabetes Medicine
Based on new data from two large clinical trials, the US Food and Drug Administration (FDA) has confirmed that the Type II diabetes medicine canagliflozin (which has brand names like Invokana, Invokamet XR, and Invokamet) comes with an increased risk of leg, toe and foot amputations.
To describe this risk, the agency added new warnings to canagliflozin drug labels, which includes a prominent “Black Box Warning”.
Studies Confirm Invokana and Invokamet Linked to Increased Risk of Amputations
The two clinical studies that were conducted to study the long-term effects of Invokana on the heart were the CANVAS and CANVAS-R trials. The final study results were reported in 2017, concluding that the risk of amputations in patients taking the drug increased by two times.
How Common are Diabetes Amputations?
The CDC – Centers for Disease Control and Prevention estimates that 23.6 million people in the United States currently have diabetes. In the past 10 years, the number of diabetic patients in the country has increased significantly from 18.2 million in 2003.
A serious concern for people with diabetes is amputations. A lot of amputations are performed on the lower extremities, particularly the feet and toes. Although it is less common, some people who have diabetes require amputations below the knee.
Nearly 67% of amputations in the US are associated with diabetes and complications that are related to it. The CDC reports that in 2010, approximately 73,000 non-traumatic amputations of the lower limbs were performed in adults aged 20 years or older who were diagnosed with diabetes.
The rate of amputation for people with diabetes is 28 times higher when compared to those who do have the disease. Amputations are performed more commonly for men than women, with a 50% higher rate of amputation for males with diabetes. Research has also found that the disease affects the non-Hispanic black population and the elderly more frequently.
Why Do People with Diabetes have a Higher Risk of Amputation?
When it comes to amputation, there are multiple factors that come into play. Although a large number of the issues that cause the need for an amputation involve, there are those that are related to the management of glucose in the body and unknown risks of certain medications.
Two major issues that create cause for an amputation are poor circulation and nerve damage, worsened by blood sugar that is left uncontrolled. These complications allow infections to set in without the knowledge of the diabetic, resulting in a gangrenous wound that could require an amputation at a later stage.
Risk Factors for Diabetic Amputations
People with diabetes have sensitive feet with a higher vulnerability to injuries, especially when blood glucose is not managed. All of the factors that cause amputations actually work together, and this is why it is extremely important to be aware of each one.
Diabetic neuropathy reduces sensation and makes patients unaware that they have injuries because they are unable to feel the development of wounds. On the other hand, poor circulation prevents injuries from healing properly. Knowing the risk factors for diabetic amputation plays a key role in prevention.
Diabetic neuropathy is a common complication that comes with diabetes. It is a form of nerve damage that high blood sugar causes. It results in injury to nerve fibers all over the body and leaves patients with a decrease in sensation in the lower limbs and feet.
Neuropathy may prevent people with the disease from feeling hot or cold temperatures. They might not notice a callus or cut, making them more vulnerable to infection.
There are 4 types of diabetic neuropathy: autonomic neuropathy, mononeuropathy, radiculoplexus neuropathy, and peripheral neuropathy.
Symptoms of this complication might include numbness, burning, tingling, and pain. Some people with neuropathy experience vision complications, bladder problems, digestive issues, and erectile dysfunction.
Diabetes may cause blood vessels to narrow and harden, limiting the flow of blood to the legs and feet. When blood flow is lacking, it can have an adverse effect on the body’s ability to fight infections and the speed of wound healing. Peripheral vascular and arterial diseases are some identifiable indicators of poor circulation.
Smoking also has an effect on the body’s small blood vessels. It can reduce the flow of blood throughout the limbs make it more difficult for injuries to heal. Many diabetics who need to be amputated are smokers.
Calluses, Ulcers, and Skin Changes
Changes in the skin, related to nerve damage, has an effect on the moisture and natural oils in the feet. When diabetes affects toe and foot skin, it results in dryness, which in turn makes it more likely for the skin to crack and peel. If there are changes in the foot’s natural regulatory state, it makes the patient more vulnerable to infection, injury, and amputation.
Caused by repeated irritation pressure or friction, calluses are also more common with diabetes. Complications can arise from calluses that are not trimmed or treated. They frequently occur on the bottom of the big toe or the ball of the foot.
Calluses may develop into painful open sores called ulcers. Neglecting treatment of ulcers or walking on them can lead to infections that are deeply embedded. Many of these are non-healing wounds that may result in the loss of a limb.
The reason for an Invokana amputation has not yet been determined or clearly understood. However, researchers confirm that the popular diabetes medication in conjunction with other risk factors makes it more likely that patients will need an amputation.
A history of prior amputation may also predispose patients who take Invokana to the need for amputation. Patients with a history of peripheral vascular disease or amputation had the highest risk of amputation, but the relative risk was similar.
Diabetes patients, regardless of a prior risk, are encouraged to discuss the potential amputation side effects of Invokana with their doctors.
Most diabetic foot infections need some type of surgical intervention, but diabetics can actually avoid many foot problems. Taking the time to learn about and understand the risk factors, key elements of proper care and all the risks that come with medications, like Invokana, can make it possible to prevent diabetic foot ulcers and amputations.
The most common amputations that diabetics taking Invokana suffer are toe and middle-of-the-foot amputations. The drug can also cause patients to need amputations of the leg below or above the knee. After taking Invokana, patients may need to have one or both of their limbs amputated.
Diabetics who take Invokana should be closely monitored for signs and symptoms of conditions that might make it necessary to get an amputation performed.
Amputations may be required as a result of infections or ulcers, especially those that reach the bone. It is important to keep in mind that even minor cuts or other punctures or trauma to the skin can result in life-threatening infections. In instances like these, patients may not be able to avoid an amputation.
Patients who take Invokana should inform their healthcare provider immediately if they develop new tenderness or pain, sores or ulcers, and infections in the feet or legs.
Diabetic Amputations vs. Invokana Amputations
According to the American Diabetes Association, diabetics are more likely to have a foot or leg amputated than other people. About 15% of people with diabetes develop ulcers on their foot, and roughly a quarter of those people will require an amputation.
Amputation can be caused by diabetes or the use of Invokana. When the legs and feet do not have proper circulation of blood, it can result in the need for both types of amputation. Invokana amputations begin with the body getting dehydrated because of increased urination that the drug causes. On the other hand, diabetic amputations often begin with blood sugar levels that are poorly controlled.
What is Invokana?
Invokana is one of the brand names of the popular Type II diabetes medication, canagliflozin. It works to lower the levels of blood sugar in patients by blocking the re-absorption of glucose in the kidneys so that the excess sugar is eliminated from the body through urination.
The active ingredient in Invokana, canagliflozin is also one of the active ingredients in Invokamet, which is a combination product and another medication used for treating the disease.
Invokana is one of the few medications that belong to the SGLT2 Inhibitor class of antidiabetics, which includes brand name medications Jardiance and Farxiga, along with combination products Synjardy, Glyxambi, and Xigduo. Since the approval of Invokana in 2013, it has been shown to increase the risk for serious side effects, which include the following:
- Diabetic ketoacidosis
- Kidney disease and renal failure
- Severe urinary tract infection (UTI)
- Increased risk of bone fracture
In May 2016, a safety alert was issued regarding CANVAS and CANVAS-R trials’ interim results which showed the doubling of amputation risk in patients taking Invokana. The risk was confirmed in the trials’ final results, which were reported in 2017.
Based on these final results, the most serious safety alert possible, the Black Box Warning, was issued by the FDA. This warning includes information about the risk of amputation.
Results of the CANVAS Trial
The boxed warning included on Invokana labeling was an addition to the information already printed on the labeling of the drug regarding an increased risk for lactic acidosis due to metformin, one of the ingredients used in Invokana.
As mentioned earlier, the risk of amputation was identified during the large, CANVAS and CANVAS-R studies which were originally undertaken to study the long-term effects of the drug on the heart.
Janssen Pharmaceuticals and Johnson & Johnson, the parent company, had hoped to find positive cardiac results for Invokana but found an increase in the risk for amputation instead.
Patients who participated in the two clinical trials were followed for 5 years. The studies compared patients taking Invokana with those taking a placebo and found that the risk for amputation was as follows:
- The placebo patients experienced amputation at a rate of 3/1,000 patients annually.
- Patients taking a daily dose of 100mg Invokana experienced at a rate of 5/1,000 patients annually.
- Patients taking a daily dose of 300mg Invokana experienced amputation at a rate of 7/1,000 patients annually.
This shows a low dose of Invokana caused an increased risk that is two-thirds higher while a higher dose resulted in more than 2 times the risk of amputation.
Amputation Risk Warnings
The safety alert regarding the Black Box Warning issued by the FDA states that health care practitioners should consider the general health of patients and specific factors before they prescribe Invokana to patients with Type II diabetes.
Conditions like leg or foot ulcers, neuropathy, peripheral vascular disease and prior history of amputation may add to the increase in the risk of amputation due to inability to sense injury and lack of blood flow. Warnings are issued to practitioners to make sure that they monitor the foot and leg health of patients and discontinue Invokana if there are any complications.
Patients are advised to report any symptoms that affect the health of their skin or extremities, such as tenderness, sores, infection or pain. However, they should not discontinue the medication without first seeking advice from a healthcare professional.
Other Safety Alerts
The Black Box Warning issued by the FDA was only the most recent safety alert in a string of notifications that involve Invokana.
In March of 2013, Invokana was the first approved SGLT2 inhibitor. By mid-2015, the agency noted that it had received a large number of adverse event reports about the medication and other SGLT2 inhibitors for events involving diabetic ketoacidosis (DKA) which had required hospitalization.
In May of 2015, a safety alert about this development was issued, which was followed by labeling changes in September about bone density loss that contributed to the increase in the risk of fracture.
Another safety warning about DKA was issued in December of 2015, which included warnings about an increase in the risk of severe UTI which may contribute to kidney failure. Updates were made to labeling to include information about DKA, UTI and kidney failure.
As mentioned earlier, the first risk warning about amputation was issued in May of 2016 based on interim results of the CANVAS study.
A month later in June, more information followed to strengthen warnings about kidney injury. The most recent warning – the Black Box Warning – was issued in May of 2017 about the potential of doubled risk of amputation that comes with Invokana and Invokamet.
The Continuing Problems of Johnson & Johnson
Janssen Pharmaceuticals is a subsidiary of Johnson & Johnson, the pharmaceutical giant that has an estimated annual revenue of nearly $72 billion. Due to problems with several of their products that range from surgical products and medical devices to consumer products such as baby powder to a number of drugs that they manufacture, like Invokana, the company has faced a number of medical injury crises.
Injuries caused by Invokana are being evaluated by regulators from across the globe, including the EU where European medical regulators at the Risk Management Committee of the European Medicines Agency have requested Johnson & Johnson to provide more information regarding the amputation risk of Invokana.
Other drugs for treating diabetes, including SGLT2 inhibitors, Jardiance and Farxiga, are also under fire. However, the same warning does not come with either drug as of yet.
Numerous lawsuits involving Invokana have already been filed by patients or family members of those who have suffered serious side effects that have been caused by the drug. Invokana lawsuits have included kidney failure, bone fracture, diabetic ketoacidosis and other serious injuries.
More of these lawsuits may be expected as a result of Invokana causing the need for amputation in some patients who take the medication.
Filing an Invokana Lawsuit
The most recent update from the United States District Court for the District of New Jersey states that trials for Invokana lawsuits are expected to begin in September 2018. There are more than a thousand Invokana lawsuits pending. At least and at the time of writing there were 1,100 Invokana lawsuits have been filed against Janssen Pharmaceuticals.
In the complaints included in these lawsuits, plaintiffs say that they would have avoided taking Invokana had they known about the increased amputation risk ahead of time. Since proper warnings were not provided by Janssen Pharmaceuticals, consumers were not able to make an informed choice on the matter.
There have been similar legal complaints about other serious side effects of Invokana. These are related to the various warnings issued by the FDA around renal failure, ketoacidosis, serious urinary tract infections, and bone fractures.
To find out if you are eligible to file an Invokana lawsuit, the first thing you should do is contact an accomplished Invokana amputation lawyer with experience in handling cases involving dangerous drugs.
This will help the lawyer learn more about your situation. Certain factors determine whether you are eligible to participate in an Invokana class action lawsuit or to file an individual lawsuit against the manufacturer. These factors include when you began and stopped taking Invokana, the side effects that it causes, and the severity of the harm you suffered as a result of taking the drug.
If your situation meets the initial criteria for case selection, the lawyer will order, pay for, and review your medical records. Board-certified physicians will also review those records to confirm that Invokana was the cause of your condition. If this can be proven, your legal counselor will determine the option that is best suited for your individual case and they can then immediately pursue that option.
Medical Bills and Other Costs
The reason that many people file Invokana lawsuits is to attempt to obtain compensation to recover costs that are related to medical bills. These costs can include surgery, hospitalization, post-operative care, and ongoing medical needs.
On top of this, the compensation can also cover related costs such as travel expenses incurred to see a specialist, lodging near centers where patients received treatment, and expenses that insurance may not cover.
Pain and Suffering
People who have experienced a severe side effect as a result of taking Invokana claim in their lawsuits that they suffered additional pain and suffering beyond what was expected due to the drug, based on the marketing and warning labels that the manufacturer provided.
While the specific suffering might differ from one patient to another – amputation, ketoacidosis, kidney disease, etc. – the common link between them is that those conditions were exacerbated or caused by Invokana.
In addition to physical pain and suffering that Invokana caused, many patients who took the drug have also suffered mentally. For instance, a number of psychological effects can result from amputation, including phantom limb syndrome, post-traumatic stress disorder (PTSD), and depression. All of these mental health conditions would not have been experienced by patients had they not taken Invokana.
In most cases, Invokana amputation lawsuits include claims to recover these costs that victims of injuries caused by the medication would not have needed to pay otherwise.
For those who passed away due to complications caused by Invokana, their families may ask for compensation to cover funeral and burial costs as well as lost income that their loved one might have otherwise earned.
Obtain the Help of a Fantastic Invokana Lawyer
If you or a loved one has received an amputation or suffered another serious complication or side effect as a result of taking Invokana, you may be eligible to file a lawsuit against the drug manufacturer. Discussing your case with a prudent and motivated Invokana lawyer is the best way to learn about your legal rights and gain more information specific to your case.
It is important to have an Invokana lawyer to help you as you will need help in understanding the strength of your case what to expect if you file an Invokana lawsuit. Fighting back against major drug companies like Johnson & Johnson will require the knowledge, skill, and resources that only an experienced legal pro has.
When you have someone who knows how to fight back against the corporation’s highly trained and well-paid lawyers, you get the best chance of receiving the compensation you deserve for complications you experienced as a result of taking Invokana.
Inferior vena cava also known as IVC filters were approved by the US Food and Drug Administration in 1979 and are now available as retrievable or permanent implants – the retrievable type being an option for short-term use.
The FDA received close to 1,000 complaints from 2005 to 2010 about adverse events associated with IVC filter removal complications and the failure of the newer retrievable filters.
There was no report from the FDA about the remaining 34.8% of adverse event reports, but a warning was issued regarding an increased risk of IVC deep venous thrombosis (DVT). In lieu of these reports, the agency set about advising health care providers to remove the retrievable IVC filters once the patient’s condition improved and there was no longer any threat of pulmonary embolism.
The unfortunate part is that a large number of the worst complications occurred when the retrievable filters were removed. Few were caused by the presence of the device in the body or the implantation procedure.
How Do IVC Filters Work?
An inferior vena cava filter is a small, metal device that is designed in such a way so as to prevent a blood clot from making its way to the lungs and resulting in a pulmonary embolism. A pulmonary embolism is a blockage in an artery that transports blood to the lungs from the heart – this blockage can sometimes be fatal.
The cage-like device is surgically implanted into the inferior vena cava, the largest vein in the body. IVC filters are made so they can trap clots, but the flip side is that these sophisticated devices can potentially move in the body and cause IVC filter complications that may have devastating consequences.
Types of IVC Filters
C.R. Bard and Cook Medical are two of the major manufacturers of IVC filters. The most popular IVC filter brands include:
- The Bard G2 filter
- The Bard G2 Express filter
- The Bard Recovery filter
- The Cook Gunther Tulip filter
- The Cook Celect filter
- The Boston Scientific Greenfield filter
As mentioned earlier, there are two types of IVC filters: permanent and retrievable (optional). Although they are intended for short-term use, retrievable filters provide the option for long-term use or removal when a risk for pulmonary embolism is no longer present. On the other hand, permanent IVC filters are designed only for long-term use.
It is important to note that IVC filter lawsuits are only being filed against the manufacturers of retrievable filters.
According to a study from 2014 that was published in the Journal of Vascular Surgery, retrievable IVC filters left in place were linked to significantly higher rates of complications than permanent filters. The authors of the study identified 383 patients with implanted retrievable IVC filters and compared them with patients who had permanent filters. It was found that blood clot-related or thrombotic and device-related were common among patients with retrievable filters.
Uses of IVC Filters
Blood clots that develop in the upper and lower extremities and deep inside the pelvis are referred to as deep vein thrombosis or DVTs.
While they are not typically life-threatening, DVTs can lead to death when they travel to the lungs and produce clots that block the normal flow of blood in the lungs, also known as pulmonary embolisms.
About 300,000 deaths occur each year due to these embolisms. It ranks third among the most common causes of death in hospital patients.
People who had recurrent DVTs while they were on blood-thinning (anticoagulation) medication and/or people who are unable to consume or tolerate these medications due to bleeding or an adverse reaction make good candidates for IVC filters.
Doctors may also recommend these medical devices in patients who undergo surgery because of an elevated risk of blood clots or suffer serious trauma.
Cases in which the use of IVC filters may be recommended include the following:
- Car accidents
- Stabbing or gunshot injuries
- Emergency or voluntary surgeries
- Dialysis treatment
- Cancer diagnosis or treatment
- Spinal cord injury
- Serious falls
- Immobile patients
- Patients who just had a baby
Complications Caused by IVC Filters
IVC filters can in certain cases float away from their surgically-positioned site thus rendering them ineffective. In some cases, the device punctures a vein, resulting in bleeding and other complications.
The filters can break into pieces, which can then travel through the blood and lodge in the heart or other organs. Retrievable filters, in particular, are linked to a number of potential risks, such as failing to stop blood clots from bypassing the device and damaging veins.
Typically, complications caused by IVC filters fall into three categories: procedural, retrieval and delayed.
Procedural IVC filter complications occur when the filter is inserted. These complications include:
- Bruising and/or bleeding in the access site
- Blood vessel puncture
- Malposition and/or incorrect placement of filter
- Deployment of defective filter
Retrieval complications occur when the filter is removed and include the following:
- Perforation of blood vessels
- Large clots in the filter that prevent device removal
- Scars in the vein that prevent device removal
- Difficult retrieval resulting in long surgery times
Delayed complications occur after the IVC filter is implanted in the patient’s body and include the following:
- Migrating to other parts of the heart, vena cava or even other organs
- Breakage or fracture of the filter
- Deep vein thrombosis
- Perforated organs
- Blockage that results in swelling in the legs
- Device infection
- Detachment of device components or embolization
Complications of IVC Filter Placement
To place an IVC filter, a doctor, in most cases, will use a catheter inserted through the skin into a large vein in the thigh or the neck and thread it to the inferior vena cava in the abdomen.
The doctor threads the filter through the catheter into the vein with the help of image guidance, including ultrasound, and x-ray and a contrast agent, or a substance that is introduced into the patient’s body so that the medical professionals are able to see.
This is a procedure that is referred to as percutaneous. It has been reported that the rate of complications from this procedure range from 4% to 11%.
Short-Term Complications from IVC Filter Placement
Other possible complications that can arise from the placement of IVC filters include the guide wire penetrating the vein, kidney dysfunction resulting from the contrast agent, blood clotting at the insertion site, bleeding or infection of the insertion site and a condition called an arteriovenous fistula (AVF), a rare complication that involves an abnormal connection between a vein and an artery. 0.02% of this complication is reported.
Short-term complications related to the procedure can include the following:
- Irregular or abnormal heartbeat
- Reaction to the contrast agent
- Pneumothorax – a collapsed lung resulting from air leaking into the space between the chest wall and the lung
- Air embolization – which is a condition wherein air bubbles block a blood vessel
- Hemothorax – a condition wherein blood pools up in the space between the lung and chest wall
Pain Caused by Defective IVC Filters
When patients experience pain with an IVC filter, it is often related to complications of the filter that may be malfunctioning or defective. Some IVC filter complications that can lead to severe pain include a blocked filter, IVC perforation, or embolization.
IVC filters can also perforate or become embedded in the wall of the IVC. But because there are no nerve endings in blood vessels, it is unlikely that patients will experience any pain that is linked to complications that directly affect the vein and they will consequently not be aware that there is a problem.
However, once the vessel has been pierced all the way through by an IVC filter, or if it breaks apart as it moves through the bloodstream, it can have an effect on other parts of the body causing pain.
The pain that often is caused due to IVC complications can affect the heart, back, abdomen or even the legs.
History of Safety Concerns about IVC Filters
The FDA issued its first safety communication about IVC filters in the year 2010. As mentioned earlier, the agency recommended removing the device once protection from pulmonary embolism was not required anymore.
The safety advisement and recommendation from the agency came after it received and reviewed over 900 reports of adverse events related to the anticoagulation device over a period of 5 years.
Adverse events that were reported included embolization, device migration, filter fractures and perforation of the IVC and organs. In most cases, these events occurred long after the risk for pulmonary embolism in the patient had subsided, yet the IVC filter was not removed from the body.
Updated Safety Communication by the FDA
The FDA issued an updated safety communication in 2014 regarding IVC filter use and removal. There were no new safety concerns in the notice.
Instead, the agency chose to report that after the risk of contracting pulmonary embolism in patients has passed, the IVC filter can be removed. The filter according to the agency’s updated safety communication could be removed between 29 and 54 days after implantation.
The federal agency developed a mathematical model using data that was publicly available from medical literature. This model suggested that the risk of having an IVC filter begins to outweigh its benefits when it is no longer necessary to prevent pulmonary embolisms.
The FDA, concluded that IVC filter complications could be certainly mitigated if doctors promptly removed the anticoagulant device after the risk for pulmonary embolism had abated.
The FDA issued a warning letter to the manufacturer of the Recovery Cone Removal System and several IVC filters, including CR Bard in 2015. The agency noted that the removal system was never given clearance and therefore, there was presumably no method that was approved for the removal of IVC filters manufactured by the company.
The regulatory agency also admonished Bard for failing to follow good manufacturing practices in the processes of manufacturing, packaging and storing its IVC filters, and for failing to establish and maintain appropriate procedures to receive, evaluate and review complaints regarding its anticoagulant devices.
The FDA further noted that CR Bard failed to report information that it received about defects linked with its IVC filters that could possibly lead to injury or death.
Complications Claimed in IVC Filter Lawsuits
People who filed IVC filter lawsuits against manufacturers claim that the devices implanted in their veins moved or broke. These problems can result in serious complications. People can file lawsuits for IVC filter complications such as:
- Blood clots
- Migration of the device
- Fracture of the filter
- Organ perforation
- Organ damage
- Impossible filter removal
It is also important to note that many IVC filter lawyers are accepting cases where no injury or complication has occurred. In other words, if you have an implanted IVC filter, you may be entitled to compensation by filing an IVC filter lawsuit (regardless of injury).
IVC filters are cone-like devices with spindly legs that deploy inside of the inferior vena cava. In some instances, the legs can puncture the veins. Or the filter can perforate or break. If this occurs, the entire filter or parts of it can travel through the body. That can result in damage to the heart, lung or other organs.
FDA Reports and Actions
Between 2005 and 2010, the US Food and Drug Administration (FDA) received 921 reports of adverse events involving IVC filters. Roughly 328 of those reports involved device migration, 70 involved perforation of the device, 146 involved embolizations, and 56 involved fracture of the filter.
Some of the reported events caused patients to experience adverse clinical outcomes. The FDA concluded that the adverse events that were reported could have been caused by a retrievable filter that remained in the patient’s body after the risk for pulmonary embolism had come down.
The agency recommended the removal of retrievable filters within 54 days after they were implanted if the risk has diminished.
The FDA has also required additional information from studies to be collected for IVC filters that are currently marketed in the United States. According to the agency, the studies address unanswered safety questions for permanent as well as retrievable IVC filters.
Manufacturers were given two options for data collection: post-market surveillance or the PRESERVE study. PRESERVE stands for Predicting the Safety and Effectiveness of Inferior Vena Cava Filters.
It is an independent national clinical study that will examine IVC filter use in the prevention of pulmonary embolism. 522 studies will be involved in post-market surveillance.
According to a study in 2016 in Seminars in Interventional Radiology, the FDA said that the data that is collected from the 522 studies and PRESERVE study will help the agency, the manufacturers of the IVC filters and health care professionals make an assessment of the use and safety profile of the filters, understanding evolving patterns in clinical IVC filter use, with the goal of ultimately improving utilization of IVC filters and patient care.
Recalls of IVC Filters
Between 2005 and 2010, manufacturers issued 6 major recalls of IVC filters. The recalls had an effect on over 81,000 units, and the majority was for issues with packaging and labeling.
Since 2015, there have been no major recalls for IVC filters. Thousands of people have reported experiencing complications caused by these medical devices. However, manufacturers have not recalled devices that are known to be most problematic.
An NBC News investigation in 2015 connected Bard Recovery and G2 IVC filters to the death of 39 people. Neither device was recalled by the company. They were replaced with similar models instead.
Cook Medical IVC filters have also come under fire for causing injuries and deaths. Hundreds of reports have been received by the FDA on Gunther Tulip and Cook Celect problems. However, the company never issued recalls for either of these devices.
Studies on IVC Filters
Studies have confirmed that retrievable IVC filters come with problems. The failure rate of the filter was looked at in a 2013 study that was printed in JAMA – Journal of American Medical Association, a group of researchers discovered that only 58 out of 679 retrievable IVC filters were actually removed by doctors.
When the filters, remained in patients longer than medically necessary, 25 patients were reported to have suffered pulmonary embolisms, 18.3% of filter removal attempts failed, and 7.8% of patients had venous thrombotic complications.
Failure Rates of Filters
Introduced in 2003, the Recovery filter was the first-generation product manufactured by C.R. Bard. The Bard G2, a second-generation device, was introduced in 2005 to replace the Recovery. However, before Bard introduced the replacement, the FDA received 300 reports of adverse events that are associated with the device.
One study had results showing that about 25% of the Recovery IVC filters failed, causing the device to break apart or fracture. While the study did not provide a reason, one patient died at home. An NBC News investigation connected the device to at least 27 fatalities.
The Bard G2 had a failure rate of 12% and remained for a shorter period of time in the market than its predecessor.
When the G2 came into the market in 2005, Bard stopped the sale of the Recovery. In 2008, the G2 Express, the G2’s successor, entered the market. One study found that all of the devices manufactured by Bard experienced a combined fracture rate of 12%.
In another study, it was found that both of the filters manufactured by Cook Medical, the Celect and the Gunther Tulip, had histories of perforating the vena cava wall of patients. In most cases, the perforation occurred within 71 days from being implanted, and the filters migrated out of place in 40% of patients.
“Significant Decline” Shown in Use of IVC Filters
A study conducted in 2017 found that IVC filter use experienced a “significant decline” after the safety warning issued by the FDA in 2010.
Researchers at St. Louis’ Washington University School of Medicine examined more than 1 million patient records that covered a period of 10 years. They saw a rise of over 22% in the use of IVC filters between 2005 and 2010. However, there was a dramatic drop in the use of these devices after the FDA advisory, going down by over 25% by 2014.
At their peak in 2010, nearly 130,000 IVC filters were implanted in patients. The number had fallen to about 96,000 by 2014.
Accusations Against Manufacturers of IVC Filters
In IVC filter lawsuits, plaintiffs claim that CR Bard and Cook Medical manufactured devices that were defective, resulting in their injuries.
They also claim that the manufacturers knew or should have known that their products were dangerous. According to the lawsuits, the companies failed to adequately warn health care providers and patients about the dangers associated with IVC filters.
The allegations in IVC filter lawsuits include:
- Defective design and manufacturing of the device
- Misrepresentation in marketing
- Failure to provide warnings about the dangers of the device
Filing an IVC Filter Lawsuit
If you want compensation for an injury caused by an IVC filter, you should file a lawsuit. However, it is important to bear in mind that cases that involve medical devices are complex.
Therefore, you should seek the help of an IVC filter lawyer as they usually have experience in handling complicated lawsuits involving medical devices. IVC filter lawsuits involve complicated medical, legal and engineering issues. With a medical device lawyer, you have a professional with acumen in these areas.
If you have suffered injury due to an IVC filter, you should consult a medical device lawyer who will review your case and determine if you are eligible to sue the manufacturer of the device. Keep in mind that your fight against major companies like CR Bard or Cook will be long and arduous.
Your legal pro will protect your rights and make sure that you are treated fairly throughout the legal process. Because the corporation will have a team of highly trained and experienced lawyers to defend them, it is crucial that you find a legal counselor who will fight just as passionately for you.
If you or a loved one has experienced a serious complication after placement of an IVC filter, you should immediately seek the help of a skilled and judicious medical device lawyer. Your attorney will determine if you should file an individual lawsuit against the manufacturer or join a class action lawsuit depending on the facts of your case.
Once you take the best legal course of action for your case, you can begin the process of suing the manufacturer of the IVC filter and receive compensation for your injury and other damages resulting from the IVC complication.
According to research conducted by the American Cancer Society in the United States, approximately 22,240 women will be diagnosed with ovarian cancer in 2018 and about 14,070 women die as a result of this cancer.
What You Need to Know About Depuy Synthes Elbow Replacement – Depuy Synthes, a subsidiary of Johnson & Johnson, developed the Radial Head Prosthesis Device, which is a medically used elbow replacement prosthetic device. This is an elbow joint prosthesis made of two pieces that are used for primary as well as revision joint of the radial head of the elbow.
Thousands of patients have experienced uncontrollable gambling, sexual behavior, eating and shopping habits while prescribed to Abilify. This type of compulsive behavior often causes great emotional distress as well as alienation from family and friends. For this reason, patients across America have begun to file lawsuits against the drug’s manufacturer, claiming they were not properly warned of Abilify’s devastating side effects.