December 7, 2020 update: Today, the FDA posted spreadsheets of reportable Essure adverse events, and Bayer posted a quarterly analysis report of Essure adverse event information. Bayer’s report included 7,332 serious injury reports, 104 malfunction reports and 73 reports. Reports represent events identified on social media and don’t necessarily represent unique cases.
Have you or someone you love experienced any of the following?
- Allergic reaction
- Heavy Bleeding
- Additional surgeries including hysterectomy
- Internal organ injury (perforation, tears)
- Chronic pelvic pain
- Accidental pregnancy
- Device migration or fracture
Essure has been a popular choice, for women who desire permanent birth control. In fact, Essure is the only permanent, non-surgical birth control option approved by the Food and Drug Administration (FDA). This option involves inserting nickel coils into the fallopian tubes via a catheter, in order to prevent conception. When compared to the traditional birth control method of tubal ligation, Essure offers a cheaper and less invasive alternative. However, thousands of women are now finding out that Essure also comes with serious risks, including death.
To date, more than 5,000 women have experienced adverse reactions to Essure. Since 2013, when 943 adverse events were filed, the number of reported adverse events has greatly increased. Such issues and reports have sparked outrage among thousands of women who want the inserts off the market. This device can perforate the uterus or fallopian tubes, causing severe pain and cramping. The device may also migrate into the pelvis or lower abdomen.
Seven deaths have been linked to Essure. One woman died while the coils were being inserted. The woman had no known medical conditions before the procedure, but before the second coil was inserted, she experienced seizures and died. The autopsy showed that her uterus had become perforated during the procedure and there was a significant amount of blood in her abdomen. Bayer Healthcare, which purchased Essure in 2013, denies that the woman died due to the device.
Bayer stands by the birth control method, claiming it has been largely successful. The company states that 750,000 women have had the device implanted, and most have developed no adverse effect. Bayer also alleges that every medical procedure comes with risks and that potential adverse events are fully-disclosed in the product’s insert. Now, the FDA is intervening to make sure patients are made aware of the risks. The agency recently added important information about Essure to its website. The information details risks associated with implantation of Essure. Bayer is said to be communicating with the FDA about the risks of the procedure and has been working to provide information to doctors and patients.
The FDA held a public meeting on September 24 to discuss the risks and benefits of Essure. The outcome has not yet been published, but the agency is expected to make recommendations on how to provide additional information to Essure patients.
If you or a loved one has been injured by the Essure implant, contact the Essure lawsuit specialists of Nadrich & Cohen, LLP. We are actively investigating claims against the manufacturer, for failure to adequately warn consumers of Essure’s potential side effects. Don’t wait, call today for a free case evaluation. We never collect a fee for our services, unless a recovery is made. Call 1-800-718-4658 now for a free consultation.