Three woman who claim to have been injured by the Essure nonsurgical permanent contraceptive are knocking on the doors of congressional lawmakers asking for support in getting the Food and Drug Administration (FDA) to pull the device off the market.
Essure, manufactured by Bayer Healthcare, is the only FDA-approved nonsurgical permanent birth control method. The device consists of two small nickel alloy coils that are inserted into the fallopian tubes where they work with the body to create scar tissue barriers that prevent the sperm from reaching the egg.
Since its approval in 2002, Essure has been linked to complications including migration from its intended position leading to perforation of the fallopian tube or uterine wall, or embedment in other organs. Often, surgeries requiring hysterectomy are required to remove the device. Other side effects include allergic reactions, severe pain, and infections.
The outcry against Essure was heard loudest on a Facebook group that has grown to more than 24,000 members who reportedly have been implanted with Essure and who subsequently posted more than 20,000 complaints related to the device. The FDA recently announced it was conducting a safety review of complaints about the device. Meanwhile, Essure remains on the market.
The women already have one supporter from the House of Representatives. U.S. Rep. Mike Fitzpatrick of Pennsylvania announced in October that he plans to introduce a bipartisan bill to Congress to ban the device.
“The Essure device is harming women and needs to be removed from the market,” he said in a prepared statement. “I believe it is imperative to the continued success of their brand and the other work they do to immediately end production of a product that poses such a danger to patient safety.”