Product Liability Update: FDA Announces New Clinical Testing for Essure
In late February 2016, the Food and Drug Administration (FDA) announced that it would take measures to further regulate the permanent birth control device known as Essure. Manufactured by Bayer Pharmaceuticals, Essure holds itself out as "the only permanent birth control with a non-surgical procedure" and is the only product of its kind approved by the FDA. Essure insertion is typically performed in a doctor's office, where the small pair of flexible metal coils is inserted through the vagina and cervix into the fallopian tubes.
The recent action from the FDA was prompted by a number of complaints over the course of several years from women who have suffered complications after having the Essure device implanted. These complaints include:
- Persistent pain
- Device migration
- Tearing of the uterus or fallopian tubes
- Abnormal bleeding
- Painful sex
- Allergy or hypersensitivity reactions
- Unplanned pregnancy
The FDA has now demanded that Bayer, the manufacturer, conduct a clinical study evaluating real-world side effects and complications associated with Essure. The agency is requiring an additional new clinical study to determine Essure's risks for particular women. The FDA will also require a "black box" warning to be placed on the packaging of Essure. A black box label is the FDA's most severe type of warning, explaining the adverse events that have been associated with the product on which it has been placed.
A "Patient Decision Checklist" will ensure women receive and understand information about the benefits and risks of using Essure, and a 60-day comment period will give doctors, the public, and the device industry the opportunity to comment on the proposed actions prior to their taking full effect.
Previously, in September 2015, the FDA called for and held a meeting of the Obstetrics and Gynecology Devices Panel to gather scientific and clinical information about Essure. This process was also designed to hear from affected women about their experiences with Essure, and ultimately led to the actions the FDA announced in February 2016.
Recently, a product liability lawsuit was filed in the Eastern District of Pennsylvania against Bayer seeking damages for injuries allegedly caused by Essure. The judge ruled that several of plaintiffs' claims were not "preempted" by FDA guidlines and that the lawsuits could proceed to the discovery phase. More information about that litigation is available here.