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# Essure Safety Review Leads to New Study
- URL: https://www.fdaweb.com/essure-safety-review-leads-to-new-study/
- Published: 2016-02-29T12:00:00.000Z
- Updated: 2026-09-15T02:39:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134904

> FDA has ordered Bayer to conduct a postmarket surveillance study on its controversial birth control device Essure as part of its just-released safety review of the product. The study should be designed to determine heightened risks for particular women, the agency says. Additionally, it has released a draft guidance with labeling recommendations including a boxed warning label and a checklist for doctors to discuss potential risks of implanted permanent birth control devices with patients. “Since Essure’s approval in 2002, the agency has continued to monitor Essure’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency,” FDA says.  
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> “The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” CDRH chief scientist **William Maisel** is quoted in a [release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm488313.htm?ref=fdaweb.com) as saying. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”  
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> FDA says that over the past 14 years it has reviewed a “significant amount of information” related to Essure’s use. “While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications,” it says. “These may include persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.”  
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> The postmarket surveillance study should be designed to provide important information about the risks of the device in a real-world environment, the agency says. It should also compare the risks to laparoscopic tubal ligation. The study findings will need to include the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. It will also evaluate how much these complications affect a patient’s quality of life. “Additionally, it will collect information to identify reasons for why some patients don’t have a confirmation test to ensure that Essure has been properly placed three months after insertion,” FDA says. “The FDA will use the results of this study to determine what, if any, further actions related to Essure are needed to protect public health.”  
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> In response to FDA’s Essure safety plan, Congressman **Mike Fitzpatrick** (R-PA) said: “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. As my constituent, Dr. **Amy Reed**, a victim of unsafe devices herself, testified at the FDA in September, ‘\[w\]e don’t need to hurt any more women.’ If the FDA is going to order another study, then at minimum they should take Essure off the market during that time.”  
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> Fitzpatrick said he will continue to work on several legislative actions, including:  
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> His call for the House and Senate to take up and pass his E-Free Act to revoke the FDA approval of Essure; Working to block government agencies from purchasing this unsafe device; andIntroducing new legislation to eliminate the blanket civil liability protections that device manufacturers like Bayer currently receive for a non-life-saving device like Essure because those harmed deserve a voice in court.