On August 20, 2020, Bayer announced that it has reached agreements with plaintiff law firms to resolve approximately 90% of the nearly 39,000 total filed and unfiled U.S. Essure™ claims involving women who allege device-related injuries. The settlements include all of the jurisdictions with significant volumes of Essure™ cases, including the state of California Joint Council Coordinated Proceedings (JCCP) and Federal District Court for the Eastern District of Pennsylvania (EDPA). The company will pay approximately $1.6 billion to resolve these claims, including an allowance for outstanding claims, and is in resolution discussions with counsel for the remaining plaintiffs.
In its consumer publication entitled, “Your Complete Guide To The Essure Procedure,” Bayer states, “Essure is a permanent birth control procedure that works with your body to create a natural barrier against pregnancy. The Essure procedure involves placing soft, flexible inserts into your fallopian tubes. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs and prevents conception. Essure was approved in 2002 by the FDA. Over 750,000 women and their doctors have chosen Essure for permanent birth control (based on units sold worldwide).”
In 2018, Bayer announced a voluntary discontinuation of sales and distribution of Essure™ in the United States, which followed a similar action in all other markets a year earlier. Bayer claimed that in both instances, “the decision was based on a decline in sales of Essure™ in recent years and the conclusion that the Essure™ business was no longer sustainable.”
The FDA completed an extensive evaluation of medical device reports submitted in 2017 and 2018 that mentioned issues involving potential Essure device removal to learn more about why women were choosing to have the device removed, which usually requires a surgical procedure. This involved evaluating more than 17,000 medical device reports submitted to the FDA in 2017 and 2018 on the Essure device. Most of these reports referenced an instance in which the device was removed from a patient, and most came from cases that were made available by plaintiff attorneys as part of litigation against the manufacturer Bayer.
From January 2017 through December 2018, there were 11,854 medical device reports related to Essure in 2017 and 6,000 reports in 2018. Of those reports, eighty-five percent (85%) referenced an instance in which the device was removed from a patient (referred to as “device removal reports” from here after).
- Eighty percent (80%) of the device removal reports cite litigation.
- The top six reported reasons in the device removal reports were:
- Pain: 60 percent (60%),
- Genital hemorrhage: 14 percent (14%),
- Device dislocation/migration/expulsion: 12 percent (12%),
- Perforation: 11 percent (11%),
- Suspected allergy to metals: 4 percent (4%), and
- Device breakage: 3 percent (3%).
Most individual reports included more than one reason for device removal.
- Sixty-six percent (66%) of the device removal reports did not provide information regarding patients’ outcomes after device removal (or the outcome was unknown).
- Of the 34 percent (34%) device removal reports that did provide information about patients’ outcomes:
- Forty-three percent (43%) stated patient symptoms resolved after device removal;
- Forty-five percent (45%) stated patient symptoms partially resolved (meaning only some of the symptoms resolved or symptoms were in the process of resolving); and
- Twelve percent (12%) stated patient symptoms were not resolved or improved.
- Ten percent (10%) of the device removal reports suggest complications directly related to device removal. The most commonly reported complications related to Essure device removal were:
- Device breakage,
- Coil migration,
- Device fragments remaining in the patient,
- Procedural or post-procedural hemorrhage, and
- Uterine or fallopian tube perforation.
- Sixty percent (60%) of the device removal reports specified a date in which the device was removed. Device removal reports included explant dates ranging from the year 2003 to 2018.
- Fifty percent (50%) of the device removal reports provided both an implant and an explant date. In these reports, the mean and median time from implant to explant were both approximately 4.5 years.
If you or a loved one suffered harm due to a medical device or implant in the United States, you should promptly consult with a medical device claim lawyer in your U.S. state who may investigate your medical device claim for you and represent you or your loved one in a medical device claim, if appropriate.
Visit our website or call us toll-free in the United State at 800-295-3959 to find medical device lawyers in your state who may assist you.
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