Essure Lawsuit

Essure Lawsuit

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.

Essure Lawsuit Infographic

Overview

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.

essure birth control

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.” 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
  • Hysterectomy
  • 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

Essure Side EffectsThere 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
  • Bleeding
  • Bloating
  • Depression
  • Heavy periods
  • Severe pelvic pain
  • Death

These are in addition to the side effects mentioned earlier.

FDA Actions and Adverse Events Timeline

FDA Essure WarningsEssure 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

lawsuitTo 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

Statute of limitations (SOL)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.

Vaginal Rejuvenation Lawsuit

Vaginal Rejuvenation Lawsuit

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:

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

vaginal rejuvenation side effects

Side effects of vaginal rejuvenation surgery include the following:

  • Dryness
  • Burns
  • Adhesions
  • Bleeding
  • Numbness or loss of sensation
  • Pain with sexual intercourse
  • Scarring
  • Significant chronic pain
  • Infection

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

FDA Vaginal Rejuvenation Warning

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,
  • InMode,
  • Cynosure,
  • Thermigen, and
  • Sciton.

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

lawsuit

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

Contact Lawyer Free Lawsuit ReviewIf 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.

Senior man suffering from chest pain in living room at home

IVC Filter Complications Lawsuit

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.

Warning Letter

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.

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