FDA’s Essure Statement Enrages Women’s Health Advocates

Fact-Checked

Editors carefully fact-check all Drugwatch content for accuracy and quality.

Drugwatch has a stringent fact-checking process. It starts with our strict sourcing guidelines.

We only gather information from credible sources. This includes peer-reviewed medical journals, reputable media outlets, government reports, court records and interviews with qualified experts.

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.”

Injured by complications related to Essure? Get a Free Case Review

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.

  •  
  •  
  •  
Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics, vaccines and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By
Kevin Connolly
Kevin Connolly Managing Editor

1 Cited Research Article

  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 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm600052.htm
View All Sources
Call to speak with a legal expert
Who Am I Calling?

Calling this number connects you with Wilson and Peterson, LLP or one of its trusted legal partners. A law firm representative will review your case for free.

Wilson and Peterson, LLP funds Drugwatch because it supports the organization’s mission to keep people safe from dangerous drugs and medical devices.

(855) 705-7637