The FDA expects to require changes to the product labeling, including a boxed warning on adverse events related to the insertion and removal procedures.
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Critics say the agency isn’t going far enough. They want the device removed altogether. Thousands of women formed statewide groups such as the Ohio Essure Sisters page to exchange information, including names of doctors who remove the device usually through a full hysterectomy.
The FDA also ordered Essure’s manufacturer, Bayer, to conduct a new clinical study to gather more data about the health risks the device might pose for “in a real-world environment”. In a February 29 press release, the site’s administrators said they are “disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device”.
“The FDA unacceptably puts patients at risk by allowing the device to continue to be marketed as this surveillance study proceeds”, Sarah Sorscher, an attorney for Public Citizen, said in an email.
This more or less permanent contraceptive method has been around since 2002, and fewer than 800,000 women worldwide have taken advantage of it. This is mainly because of concerns that it might generate some complications. When Monday’s FDA directive did not take that step, the Essure Problems site called for congressional action and for patients to write their members of Congress. “It’s been done. The evidence is all there”, Fitzpatrick said.
Rep. Rosa DeLauro (D-CT) said the agency’s “actions mean nothing” unless the FDA is prepared to act. Studies have shown that if the device is correctly implanted, the chance of pregnancy is less than 1 percent, the FDA said. “I have to do IV infusions just to be able to be able to take care of my kids or walk or stand up 2 times a week now”. The coils are implanted into the fallopian tubes to prevent pregnancies. In about three months, scar tissue forms that would create a barrier from the egg cells and sperm cells, preventing fertilization.
Essure may be a suitable option for the majority of women who desire permanent birth control, but 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.
Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a news briefing Monday that the agency has received 631 reports of women becoming pregnant while using the product, and 294 reports of pregnancy losses.
“They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications”, he added.
According to an article in the Washington Post, the agency will require the placing of a “black box” label containing a warning about the side effects, and will provide a checklist for doctors to discuss with their patients about the risks associated with the device. That’s why she says to talk to your doctor to decide if the product is right for you.
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The clinical studies will evaluate complications linked to the use of the device and compare them to traditional methods like ligation.
