FDA imposes new restrictions on Essure sales
In a statement on April 9, 2018, FDA Commissioner Scott Gottlieb announced that the agency imposed “unique” restrictions on sales of permanent contraceptive device Essure due to what he described as an “unacceptable” number of women who were being implanted without full knowledge of the risks the device could pose to their health.
“Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information,” Gottlieb said. As a result, Essure manufacturer Bayer will only be authorized to sell the device to health-care providers and facilities that provide, and collect signatures confirming that patients have received, a detailed checklist explaining known complications. The checklist was originally added to the device’s label in 2016. Now, Bayer must ensure that patients receive the information or face potential criminal or civil penalties, the FDA announced.
Motley Rice medical attorney Fidelma Fitzpatrick serves as lead counsel of the Plaintiffs’ Executive Committee for Essure litigation coordinated in California state court. “We are encouraged by today’s announcement by the FDA and that the injury claims are being taken seriously and measures are being implemented to help future women from being harmed,” said Fidelma. “We agree with the FDA that all women should have received adequate warnings about the true complications associated with Essure before it was received; at a minimum, there was an absolute obligation to tell women that they could be seriously injured if they chose Essure as a birth control option.”
The FDA has received more than 26,000 medical device reports of severe injuries allegedly caused by Essure, including life-threatening ectopic pregnancy, miscarriages, device migration, perforated organs, and other effects. A surgical procedure is usually required to remove the device.
While Bayer has denied any wrongdoing and maintains that the device is safe, the FDA added a black box warning to Essure’s labeling in 2016. A black box warning is the FDA’s highest warning level and indicates that a product may cause serious injuries or death.