Bayer Faces Thousands of Essure Injury Lawsuits Product liability lawsuits continue to be filed against Bayer alleging injuries from Essure, the female sterilization device. In the United States, roughly 3,700 lawsuits have been filed. Litigation has also begun in Canada. The U.S. Food and Drug Administration (FDA) reports over 10,000 injuries and 30 deaths associated with the use of Essure, regulators said in a recent update.
The product liability attorneys at Parker Waichman LLP are keeping up-to-date with litigation news regarding Essure and other medical devices. The firm continues to offer free legal consultations to individuals with questions about filing an Essure lawsuit.
Essure is a permanent female sterilization device that consists of two metal coils. Each coil is inserted into a fallopian tube. Scar tissue is supposed to grow around the coils and permanently prevent conception. Conceptus, which was acquired by Bayer in 2013, originally developed Essure in the 1990s. The device was approved in 2002. In recent years, Essure has been the subject of safety concerns and personal injury lawsuits.
According to Modern Healthcare, a total of 14,919 Essure adverse event reports were submitted to the FDA between its introduction and the end of 2016. Women reported injuries such as device migration, organ perforation and severe pain.
Bayer is reportedly facing 3,700 Essure injury claims in the U.S., and two Essure lawsuits are seeking class certification in Canada. As litigation is on the rise, the company’s 2016 annual report indicates that Essure impairment losses totaled $413 million.
Women suing over Essure allege that the sterilization device is defective, causing severe complications. The lawsuits allege that Bayer knew or should have known about the dangers of Essure but failed to warn patients or the medical community. For example, plaintiffs and safety advocates have criticized Bayer for failing to disclose the presence of nickel in Essure, which can cause a hypersensitivity reaction in some women. Bayer says it expects additional Essure lawsuits to be filed.
One Essure user, a 36-year-old woman from Texas, was implanted with the device in August 2014. She told Modern Healthcare that she suffered from cramping and bleeding by the end of that year. More than a year later, the bleeding continued, ultimately prompting her to undergo a hysterectomy. The woman has since been diagnosed with chronic fatigue, irritable bowel syndrome, fibromyalgia and insomnia.
“I literally went from having no medical problems before this, to bleeding for about 424 days, to having a hysterectomy as a young mother with three kids,” she said to Modern Healthcare. “I’m still having issues, even though I got it out.”
As Essure is becoming controversial, some experts expect Bayer to remove the device from the market. “I’ll be surprised if Essure is being sold 15 months from now,” said Erik Gordon, a professor at the Ross School of Business at the University of Michigan to Modern Healthcare. “If Bayer doesn’t pull it, I think the FDA will.”
In Brazil, regulators recalled and suspended sales of Essure. The nation’s National Health Surveillance Agency, Anvisa (Agencia Nacional da Vigilancia Sanitaria), said it halted importation, distribution, and marketing of Essure. Additionally, units that have already been distributed are being recalled. Essure was approved in Brazil in 2009.
Globally, Bayer estimates that 750,000 units of Essure have been distributed.
FDA Reports over 10,000 Essure Injuries and 30 Deaths
In a recent update, the FDA said it received 5,019 adverse event reports related to Essure in 2016. The year prior, the agency received 6,176 Essure adverse event reports.
According to the FDA, the most common adverse event reports included:
- Pain/abdominal pain (10,746)
- Heavier menses/menstrual irregularities (5,377)
- Headache (4,396)
- Fatigue (3,560)
- Weight fluctuations (3,270)
Among device problems, the FDA said, the most common adverse event reports included:
- Patient-device incompatibility (2,402) (for example, possible nickel allergy)
- Migration of the device or device component (1,485)
- Device operating differently than expected (663)
- Device breakage (617)
- Device difficult to remove (304)
- Malposition of the device (261)
- Device difficult to insert (257)
In most cases, patients reported multiple issues. The FDA also said there were 30 reports of death through Dec. 31, 2016. This includes four adult deaths, 18 pregnancy losses, two reports of infant deaths following a live birth and one report of an unspecified death. The FDA says that it has received 1,077 reports of 1,113 pregnancies in women implanted with Essure. Multiple pregnancies were reported in some women. The reports included 253 live births, 474 and pregnancy losses; 386 did not indicate whether the pregnancy led to a live birth or pregnancy loss.
Among the pregnancy losses, 138 reports were listed as ectopic pregnancies, 261 were listed as other pregnancy losses and 75 were elective terminations, according to the FDA update.
FDA Mandates Essure Black Box Warning
In 2016, the FDA required Bayer to include a “black box” warning, for Essure, in addition to a patient checklist. A boxed warning is most serious type of warning that can be placed on a drug or medical device. The boxed warning discloses a risk of the device perforating the uterus and/or the fallopian tubes, persistent pain after the procedure, changes in the menstrual cycle, allergic reactions and symptoms similar to autoimmune diseases such as joint pain and fatigue.
Healthcare professionals can use the checklist to fully review the risks of Essure with each patient before the device is implanted. Information on the checklist includes rates of unplanned pregnancy, ectopic pregnancy and common side effects such as pain and cramping after implantation.
In September 2015, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to address the growing number of Essure complaints, which had picked up substantial momentum at that point. The panel discussed recommendations for adverse events reported among Essure users, including autoimmune response and allergic reaction, persistent pain, device removal, migration, perforation and bleeding. Panel members concluded that the device may be inappropriate for some women, including those with a nickel sensitivity, chronic pelvic pain, autoimmune disorders and previous uterine surgery.
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