The Food and Drug Administration (FDA) fell short of ordering a ban of the controversial Essure permanent birth control method, instead recommending a black box warning be placed on the device and a patient checklist included in the packaging that informs of possible risks including perforation of the uterus or fallopian tubes, coil migration, hypersensitivity reactions, and chronic pain.
The agency also ordered Bayer Healthcare, maker of the contraceptive device, to perform a postmarket data to compare adverse events with Essure compared to bilateral tubal ligation.
The agency said that despite the risks, the product should remain on the market for women “who are adequately informed of the risk,” said William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Device and Radiological Health.
The recommendations come after a months-long safety review by the FDA prompted by more than 5,000 adverse event reports associated with the device sent to the FDA’s database MedWatch. Eighty percent of those complaints were reported since October 2013.
Essure was approved by the FDA in 2002 and remains the only non-surgical permanent birth control method on the market. It consists of two nickel alloy coils that are inserted into each of the fallopian tubes. Scar tissue builds up around the coils, creating a barrier that prevents the sperm from reaching the egg.
The devices have been linked to side effects including allergic reactions, chronic pain, and infections. The device can also migrate and perforate the uterus or fallopian tubes, or become embedded into other organs. In some cases, surgery such as hysterectomy is required to remove the device.
The FDA says Essure has been linked to five fetal deaths, however an independent analysis revealed more than 300 fetal deaths were associated with the implant.
The public will have 90 days to comment on the labeling and informed-consent requirement the FDA has proposed.
Rep. Mike Fitzpatrick, who introduced legislation to ban Essure, responded with this statement: “It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market. Frankly, I’d contend that the 25,000 women harmed by Essure are the postmarket study that FDA is ordering. It’s been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths.”