Pharmaceutical giant Bayer has agreed to pay $1.6 billion in Essure injury settlements. Tens of thousands of women have reported that the medical device caused injuries after insertion. The settlement may be a relief for many women, but it appears that Bayer is not planning to offer an apology for the injuries their medical device caused. The company continues to deny any wrongdoing or liability for the thousands of injuries reported by women using the device.
Information about Essure Injury Settlements
There are at least 39,000 lawsuits claiming that the Essure device causes internal injuries. Women report a variety of injuries, including:
- Abdominal pain
- Perforation of the fallopian tubes
- The device migrating to the uterus or other abdominal organs
- Device breakdown causing fragments to damage organs and tissue
- Device failure leading to pregnancy
- Ectopic pregnancy
- Depression and anxiety
In addition to the thousands of lawsuits filed claiming injuries, there are also 57 reports of death related to Essure. There are also somewhere between 18 and 300 reports of women experiencing miscarriages while using Essure.
Bayer says the substantial settlement will resolve around 90 percent of the lawsuits.
Information about Essure
Essure is a birth control device approved by the U.S. Food and Drug Administration (FDA) in 2002. After approval in 2002, around 750,000 women had the Essure device inserted.
The device promised permanent birth control without surgery or daily pills. The Essure device is inserted through the vagina and cervix into the fallopian tubes. About three months after insertion, scar tissue builds up, preventing sperm from reaching an egg.
The Bayer Essure patient booklet lists the following benefits of Essure:
- Minimally invasive
- Insertion process takes less than 40 minutes
- No anesthesia
- Only 1-2 days of downtime after insertion
- Essure Confirmation Test can ensure the device is in place and reliable
- Highly effective (99.3% effective at preventing pregnancy)
The booklet and the FDA list the possible side effects of using the Essure device as:
- Mild or moderate pain
- Vaginal bleeding
- Back or pelvic discomfort
- Pelvic pain
- Unintended pregnancy
- Perforation of the uterus or fallopian tubes
- Allergic reaction
- Symptoms of autoimmune disease
For many years after approval, patients did not know just how serious the risks were. Hundreds of thousands of women continued to trust that the device would perform as intended and marketed.
History of Essure and Injury Claims
In 2015, the FDA met with the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. The meeting included clinical and scientific opinions about the Essure device. It also included experiences from women who used the device. The meeting and subsequent public comments was enough to raise concern with the FDA. They ordered Bayer to begin post-market surveillance on the risks and benefits of Essure.
In 2016, The FDA ordered Bayer to include a black box warning on Essure. The black box warning would include the risks of abdominal pain, allergies, perforation and other possible complications.
In 2017, the FDA announced that they were evaluating Essure due to the number of adverse event reports they had received. In 2018, the FDA restricted sale and distribution of Essure. They only allowed sales and distribution to healthcare providers who agreed to utilize Bayer’s Patient-Doctor Discussion Checklist. Healthcare providers were instructed to review the document with patients and have them sign it before implanting the device. This move was in an effort to ensure that Essure was being used within FDA safety standards. At the time, the FDA also approved new labeling that included language about the checklist.
Just two months after the FDA restricted sales, Bayer announced that they were pulling Essure from the market in December 2018. The FDA worked with Bayer to address concerns about patient complications, including approving revisions to follow up studies.
Are Essure Injury Settlements the End?
Essure injury settlements may offer some level of justice for the women involved and their loved ones. Unfortunately, no amount of money can truly compensate them for what they have, and continue to, experience. Many women who used Essure have had to undergo surgeries, including life-changing surgeries like hysterectomy. Some women have suffered miscarriage or ectopic pregnancy. Some women even lost their lives as a result of using Essure.
The Essure injury settlements may be a resolution to these lawsuits, but there will never be an “end” to the battle that these families continue to face. A medical device designed to help improve their lifestyle and support their family goals has resulted in traumatic injury and death.
While it is good to hear that Bayer is settling these cases and providing some sense of resolution for these women, it is impossible to truly quantify what these women and their families have been through. It also does not excuse Bayer’s failure to warn women about the dangerous risks of Essure for years after approval.