The Food and Drug Administration (FDA) held a meeting of its Medical Devices Advisory Committee’s Obstetrics and Gynecology Devices Panel to discuss the risks and benefits of the Essure birth control system.

The FDA committee meeting was scheduled for Sept. 24, 2015, at the FDA’s White Oak Campus in Silver Spring, Md. Anyone who wanted to comment on the issue was able to do so on the docket for public comment, which FDA left open until Oct. 24, 2015. Comments submitted on or before Aug. 31 were made available to the committee before the meeting, and comments received after that were considered by the agency.

What is Essure?

Essure is a method of birth control designed to be an alternative to surgical sterilization for women who want a permanent method of birth control. It consists of coils made of nickel and a polyester-like material. The Essure coils are inserted through the vagina and uterus and into the fallopian tube. Its presence there stimulates the growth of scar tissue that ultimately blocks the fallopian tube, preventing fertilization.

Essure birth control was originally developed by a company named Conceptus, who since then sold the product to Bayer HealthCare. When Essure was first approved by the FDA in 2002, it was touted as a breakthrough alternative to tubal ligation. The implantation procedure could be performed in a doctor’s office in about 10 minutes.

Since then, Essure’s history has been tainted with reports of potentially damaging complications. The list of reported Essure complications includes perforation of the fallopian tubes or uterus, migration into other parts of the abdomen, allergic reactions to the nickel in the implant, pelvic pain, and unintended pregnancy – which in some cases resulted in ectopic pregnancy.

The FDA says as of the end of May 2015, it has received 5,093 adverse event reports related to Essure. Four of these cases resulted in death, and five were cases of pregnancy following Essure implantation that ended in fetal death. Some reports mention less common complaints such as headache, fatigue, and fluctuations in weight.

Essure Lawsuits

At least five Essure lawsuits have been filed against Bayer and are now pending in federal court in Pennsylvania. The plaintiffs face an obstacle in possible federal preemption that would bar their state tort law claims.

A provision of the federal Medical Device Amendments Act of 1976 preempts state regulation of medical devices. In 2008, the U.S. Supreme Court held this provision also preempts state law product liability lawsuits regarding devices that, like Essure, received pre-market FDA approval under the amendment.

To get around this possible preemption of their claims, plaintiffs are now attacking Bayer’s performance under the terms of the FDA’s approval for Essure. The FDA imposed certain conditions on its initial pre-market approval for Essure, one of which was a requirement that its manufacturer report adverse events associated with use of Essure.

The plaintiffs now allege Bayer subsequently concealed relevant information about such events, in violation of the FDA’s terms. Therefore, Bayer cannot assert the protection from liability that FDA pre-market approval would provide, the plaintiffs argue.

These Essure lawsuits are Case Nos. 2:14-07315, 2:14-07316, 2:14-07317, 2:14-07318, and 2:15-00384 in the U.S. District Court for the Eastern District of Pennsylvania.