In Light of Patient Complaints, FDA to Reconsider Safety of Essure Permanent Birth Control

FDA to Reconsider Safety of Essure Permanent Birth Control

FDA to Reconsider Safety of Essure Permanent Birth Control

The U.S. Food and Drug Administration (FDA) will be re-evaluating the safety of Essure following complaints from patients who say the permanent birth control device caused painful complications. Currently, it is the only approved permanent nonsurgical form of contraception on the market. NPR reports that the agency’s Obstetrics and Gynecology Devices Panel will hold a public advisory hearing on September 24th. During the meeting, experts, physicians, patient and industry advocates with convene to discuss the device and hear public comments from women implanted with it. The FDA has also updated its adverse events reported through May as well as the short- and long-term risks listed on its website.

Bayer received FDA approval for Essure in 2002. The device, which is approved for women between the ages of 21 and 45, is a flexible metal spring composed of a nickel-titanium allow that is inserted into each fallopian tube by an OB-GYN. Essure prevents pregnancy by blocking the fallopian tubes as scar tissue grows around it, not allowing eggs to become fertilized or travel to the uterus.

NPR interviewed Amanda Dykeman, who says she suffered from a variety of complications after having Essure implanted in 2010, including chronic fatigue, migraines, joint pain, digestive issues, back pain, heavy periods full of clots, difficulty concentrating, abdominal pain, hair loss, tooth deterioration and depression. She also told NPR that she suffered from severe bloating that sometimes prevented her from going out. “Physically, it has permanently ruined my body inside and out,” she said to NPR.

According to NPR, over 5,000 reports of adverse events related to Essure have been reported to the FDA. The most prominent complaints are of abdominal pain, headaches, fatigue and weight fluctuations. There were 400 reports of Essure migrating from the fallopian tubes to other parts of the reproductive system and 5 cases where Essure did not prevent pregnancy, ultimately resulting in fetal death. NPR notes that since the reporting system is passive, it is unknown how many reports are duplicates and whether or not these conditions were actually caused by Essure. Additionally, there may also be Essure-related injuries that go unreported.

Elizabeth Micks is an OB-GYN and contraception specialist at the University of Washington Medical Center in Seattle. She told NPR that more research should be done to determine long-term complications with Essure. “Most of the data we have are from the clinical trials, and you can’t necessarily go by the clinical trial data in looking at complications because obviously some women in real life practice aren’t following up, so we don’t really know if they have a malposition of their coils,” she said, according to NPR. “It’s frustrating to be told we don’t have the data, but I feel like the terrible cases I’ve seen are really people who were not properly informed about the risks and benefits ahead of time. I think the bigger problem is what physicians are communicating with patients.”

This entry was posted in Legal News and tagged , , , , . Bookmark the permalink.

© 2005-2020 Parker Waichman LLP ®. All Rights Reserved.