Essure Birth Control Lawsuit

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Can I file a lawsuit because I was injured by Essure birth control?

Thousands of women who have used Essure permanent birth control implant have filed lawsuits against the device’s manufacturer, Bayer.  The device has been linked to uterine and fallopian tube perforation and other serious injuries and has been the subject of numerous FDA safety warnings.  Most recently, Bayer has announced that they will discontinue sales of Essure but may expect more lawsuits.

Essure, a birth control implant was approved in 2002 and was marketed as “non-surgical permanent birth control”.  Since that time, about 30,000 serious adverse event reports have been filed with the U.S. Food and Drug Administration for injuries caused by the device.  Thousands of women who used Essure have filed lawsuits against its manufacturer, Bayer, for serious injuries caused by the device.

What is Essure?

Essure is a Class III medical device developed by Conceptus and was first approved by the FDA in 2002.  In 2013, Conceptus and its product, Essure were acquired by Bayer, who also manufactures intrauterine device, Mirena and a number of birth control products.

Essure is constructed of two coils made of a nickel alloy and a nylon fiber.  The device is positioned in the uterus so that the metal coils are inserted into the fallopian tubes. The coils trigger the development of scar tissue, which blocks the fallopian tube and prevents fertilization of an egg released by the ovaries.

Placement of Essure is done on an outpatient basis, in a doctor’s office or medical clinic.  Its placement does not require surgery or any type of incision but is done through the vagina.  Essure is intended to remain in place as a permanent birth control device.  In the event of a problem however, removal may require surgery.

In 2016, as a response to numerous reports of injury which prompted further investigation, the FDA issued a “black box warning” notice.  The FDA required that information about the risks of Essure be included on all instructions and that patients be given an information checklist.  In April of 2018, the FDA required that Bayer limit sales of Essure to physicians’ offices and medical clinics which could ensure that patient education would be adequate according to FDA requirements.

Worldwide, more than 750,000 Essure units have been sold and placed, many of these resulting in serious injury.  Essure was removed from the market in the EU and other non-U.S. countries in 2017 and Bayer has stated that it will discontinue selling the device in the U.S. at the end of 2018.  The company claims that the decision is based on declining sales and not because of what it claims are “misleading” media reports.  Bayer has stated that the product remains safe and they will continue to provide post-market surveillance which had been ordered by the FDA.

Essure Problems

Despite some Essure users reporting success with their device, numerous problems have arisen. The FDA has received more than 27,000 serious adverse event reports regarding the device and has issued a number of safety alerts.  The severity of adverse events range from abnormal bleeding and pain to device migration and organ perforation.

Reported adverse events include:

  • Severe abdominal and pelvic pain
  • Cramping
  • Nausea and vomiting
  • Dizziness and fatigue
  • Hair loss
  • Internal bleeding
  • Migraines
  • Autoimmune problems
  • Allergic reaction
  • Device migration and expulsion
  • Perforation of the fallopian tubes
  • Perforation of the uterus
  • Miscarriages after unintended pregnancies
  • Death

Bayer Accused of Filing False Information

According to claims filed against Bayer, the company was aware of the problems related to Essure and failed to make the information public.   In addition, Bayer has been accused of falsely reporting information and representing the product as safe.

Essure, developed by Conceptus, was approved by the FDA in 2002 under the Premarket Approval (PMA) process.  It was “fast-tracked” and approved with conditions that the company provide additional 5-year safety data after approval.  Conceptus failed to deliver analysis reports on time at each reporting period until the company was acquired by Bayer in 2013.

Upon submission review, it became clear that Conceptus had only monitored three quarters of the women for the required full five-year period.  Several Essure users involved in the study later reported that their information was inaccurate and the FDA also found at least six cases of data tampering but noted that it appeared to be “sporadic” and “did not reveal a pattern”.

Despite these problems with safety data and a growing number of adverse event reports, Bayer did not withdraw the device and continued to market the product as having a positive risk/benefit profile.  In 2015, several consumer groups along with members of Congress called for the device to be withdrawn.

In 2016, the FDA took an unusual step and though they did not recall the device, a black box warning was issued.  The agency also required that patients be given a safety information checklist but fears and reports indicated the requirements were inadequate prompted them to restrict sales of the device.  Essure was withdrawn from non-U.S. markets in 2017, and Bayer has stated they will stop selling the device in the U.S. at the end of 2018.

Thousands of injuries and more than two dozen deaths linked to Essure

Nearly 30,000 serious injury reports have been received by the FDA, including a number of deaths.  Deaths associated with Essure use have included four women using the device, 18 miscarriages and two infant deaths following live births when the mother had used Essure.

Despite these problems with safety data and a growing number of adverse event reports, Bayer did not withdraw the device and continued to market the product as having a positive risk/benefit profile.  In 2015, several consumer groups along with members of Congress called for the device to be withdrawn.

In 2016, the FDA took an unusual step and though they did not recall the device, a black box warning was issued.  The agency also required that patients be given a safety information checklist but fears and reports indicated the requirements were inadequate prompted them to restrict sales of the device to clinics who could meet stringent information guidelines.

Essure was withdrawn from non-U.S. markets in 2017, and Bayer has stated they will stop selling the device in the U.S. at the end of 2018 but have claimed that the decision is a commercial one, based on declining sales and not related to the safety of the device.

Filing an Essure lawsuit

Thousands of lawsuits have been filed against Bayer for injuries caused by Essure.  The plaintiffs believe Bayer misled consumers and not enough research was done in advance to prove Essure’s safety. To date, five federal Essure cases include negligent misrepresentation charges against Bayer.

Women who have been injured after using Essure may be eligible for compensation for their injuries.  In the past, damages have been awarded for medical costs, lost wages, pain and suffering and in the case of a death, for wrongful death.

If you or a loved one was injured by Essure, you should contact an attorney to discuss your case.

 

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