Essure Birth Control Implant Restricted by FDA

In April the Food and Drug Administration announced new restrictions that would compel Bayer to restrict sales of its Essure birth control implant to medical practices, and those practices would be required to fully inform women about the device’s risks. Doctors must review with patients a checklist of the side effects, and both are required to sign it.

There are currently thousands of lawsuits against Bayer regarding the Essure device. Women have come forward complaining of devastating pain and injury caused by Essure birth control. These complaints include a range of symptoms ranging from mild to severe, including pain, weight fluctuation, menstrual irregularities, hemorrhaging, headaches, and issues related to device migration. In many cases complications have led to the need for a total hysterectomy to remove the implant.

Since Bayer introduced Essure in 2002 More than 750,000 Essure devices have been sold worldwide. According to the FDA in the 15 years following 1the products release, the agency received 26,773 reports of problems, including pain, heavier periods and irregular bleeding, headaches and fatigue. Patients also reported that the device had become dislodged or had broken. And the agency has received reports of eight adult deaths related to Essure. The product is no longer sold outside the United States.

In 2016 the FDA had issued a black box warning for Essure. This is among the strongest actions the FDA can take – short of product recall – to warn the public about potential dangers of a drug or device. The agency took the extraordinary step of adding this recent notification requirement to the previous black box warning because, according to FDA Commissioner Scott Gottlieb, “despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information.”

In a related event, the FDA has also announced new guidelines for how it approves medical devices for U.S. patients. The Medical Device Safety Action Plan was announced three days before a documentary premiered at the Tribeca Film Festival called “Bleeding Edge,” which chronicles complications resulting from medical devices — including Essure — and procedures that received little or no testing.

It was only by originally exploiting FDA protections and using the agency’s fast track process that the Essure device even made it to the market in the first place. Essure’s severe side effects are well documented, and the health of tens of thousands of women has been compromised. The time has come for Bayer to accept responsibility for producing this defective medical device and for failing to warn women of the risks associated with having it implanted.

At Saunders & Walker we have a long history of representing patients harmed by dangerous and defective drugs and medical devices. If you, or a loved one has used Essure for birth control and suffered any side effects or injuries after the device was implanted you may be entitled to financial compensation. Please do not hesitate to contact us for a free consultation.