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Essure, an implantable birth-control device, has been on the market for nearly 14 years, but after recent litigation and reports of injury to thousands of women, the U.S. Food and Drug Administration (FDA) concedes it's time to take a closer look at its safety record.

The agency is ordering Bayer, the device's German manufacturer, to conduct a clinical study to measure the real-world safety record of Essure, a permanent form of sterilization. It will also require a "black box" warning label on the device.

Critics say the agency isn't going far enough. They want the device withdrawn from the market pending further research. "If Essure was harming and killing men, it would have been withdrawn from the market already," said a posting on the Facebook page of Essure Problems, a group of women affected by the devices.

"These studies could take several years, and leaving the device on the market will only put more women's lives at risk," the group said, while questioning why the FDA would permit Bayer to conduct the studies, basically allowing it to study itself. "We are disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device."

Bipartisan critics

PhotoThe FDA held a day-long conference about Essure in September, where it heard from many women patients and their advocates. Critics say it's scandalous it took the agency six months just to decide to conduct a study to gather more data on the issue. 

"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," said Rep. Mike Fitzpatrick (R-PA), who has been among Congressional critics calling on the agency to pull the device form 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," Fitzpatrick said. 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."

Rep. Rosa DeLauro (D-CT) said the agency's "actions mean nothing" unless the FDA is prepared to act. 

“Women and their doctors have filed more than 5,000 adverse events reports to the FDA regarding the negative side effects of Essure, yet the device is still on the market," DeLauro said. “Last year, the GAO released its findings on a report I commissioned, showing that the FDA’s requests for postmarket safety studies often take a long time to be completed, and that companies lack incentive to find participants for their studies. Now, the FDA is asking Bayer to do a postmarket study, all while there is no evidence that the FDA has remedied the issues found within the GAO report."

"FDA needs to take accountability in ensuring that these manufactures are completing these postmarket studies in a timely manner. In the meantime, Essure should be off the market until the requested studies are completed," DeLauro said.

Recent lawsuits have alleged that Bayer actively concealed adverse events from the FDA when it won pre-market approval from the FDA in 2002. 

Flexible coils, scar tissue

Essure works through the insertion of flexible coils through the cervix and vagina into the fallopian tubes. Over a period of about three months, scar tissue forms around the inserts and creates a barrier that keeps sperm from reaching the eggs, thus preventing conception.

The FDA said that over the past 14 years, it has reviewed a "significant amount of information" and believes Essure remains an "appropriate option for the majority of women seeking a permanent form of birth control."

But the FDA said some women may be at risk for serious complications, including persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding, and allergy or hypersensitivity reactions.

“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,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”

Boxed warning

Besides the clinical study, the FDA said it intends to order changes to product labeling, including a boxed warning and a "patient decision checklist" to help to ensure women receive and understand information about the device.

The checklist includes proposed language for doctors to use with patients to better communicate risks and help to ensure an informed decision-making process. The checklist will also help doctors discuss the importance of undergoing a “confirmation” test three months after the device is implanted to determine whether the implants are properly placed and that scar tissue has formed to prevent pregnancy.

The checklist should be completed and signed by the patient and physician prior to proceeding with a permanent hysteroscopic sterilization procedure, such as Essure.

Post-market study

The post-market study that will gather data to help compare Essure and other implantable sterilization devices laparoscopic tubal ligation. The study will be looking for complications, including unplanned pregnancy, pelvic pain, and other symptoms, as well as surgery to remove the Essure device.

Additionally, the study 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. 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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