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FDA’s Essure Statement Enrages Women’s Health Advocates

Serious women against Essure

Essure critics this week fired back after the FDA’s chief defended the controversial birth-control device, despite mounting complaints and an ongoing review by the agency and the manufacturer.

“While the FDA continues to believe that Essure may be appropriate for some women based on our current information, the agency also recognizes that serious problems have been associated with its use,” FDA Commissioner Scott Gottlieb said in a statement March 7, 2018.

The U.S. Food and Drug Administration received nearly 12,000 reports about Essure in 2017, Gottlieb said. Most were filed between October and December. The FDA is investigating.

Essure critics see Gottlieb’s statement as a lack of commitment to patient safety.

“I am not surprised that he sided with industry, as always,” Essure Problems founder Angie Firmalino told Drugwatch. “The FDA is no longer an entity that protects the people. They are now an entity to serve the industry.”

The commissioner’s statement follows his meeting with members of the Essure Problems group and other advocates in early February 2018.

Many of the women shared their stories at the meeting.

They reported complications such as autoimmune problems, bleeding, chronic pain and punctured organs. In addition, the FDA received hundreds of fetal death reports.

Madris Tomes of Device Events provided the commissioner and other FDA personnel with Essure complications data from the agency’s own database. Tomes is an independent data analyst and former FDA consultant. She is also a contributing expert for Drugwatch.

The FDA said it would monitor Essure adverse events and communicate its findings with the public. But, Gottlieb promised no further regulatory action at this time.

Essure is currently only available for sale in the U.S. and thousands of women have filed lawsuits against Bayer.

Last modified: March 8, 2018


Michelle Y. Llamas is a senior content writer. She is also the host of Drugwatch Podcast where she interviews medical experts as well as patients affected by drugs and medical devices. She has written medical and legal content for several years — including an article in The Journal of Palliative Medicine and an academic book review for Nova Science Publishers. With Drugwatch, she has developed relationships with legal and medical professionals as well as with several patients and support groups. Prior to writing for Drugwatch, she spent several years as a legal assistant for a personal injury law firm in Orlando. She obtained her English – Technical Communication degree from the University of Central Florida. She is a committee member with the American Medical Writers Association.

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  1. FDA. (2018, March 7). Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA’s commitment to keep women informed. Retrieved from
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