After years of receiving reports of painful complications from thousands of women, the U.S. Food and Drug Administration (FDA) has placed new restrictions on a permanent contraceptive implant known as Essure.
The Associated Press (AP) is reporting on the new restrictions placed on the sterilization device which consists of a two small metal coils that are inserted into a woman’s fallopian tubes. The coils cause a buildup of scar tissue that keeps eggs in the ovaries and blocks sperm from reaching them.
The problem with the device is that it can cause crippling pain, allergic reactions to the nickel and polyester components, and migration of the coils that can embed in other organs. As of last year, more than 15,000 women reported complications to the FDA. Four deaths are associated with the device as well as 300 miscarriages and many unexpected hysterectomies.
These problems are not just limited to the U.S. The product has been withdrawn from the market in Finland, the Netherlands, the United Kingdom and in Canada. The European Union suspended its sales for three months in 2017. The Australian government not only withdrew the device from the market, it also recalled all unused stock of Essure devices so that there will be no further implantation in Australia.
In addition, Bayer,the manufacturer of the device, is facing lawsuits from approximately 16,000 U.S. women and even though they are insured against product liability suits, the company admits that the claims “exceed the available insurance coverage.”
The new restrictions will now limit sales of the device to women who have read and signed a brochure outlining all the risks associated with the device. The checklist must also be signed by the woman’s doctor before it can be implanted.
“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” said FDA Commissioner Scott Gottlieb, MD. “Despite previous efforts to alert women to the potential complications of Essure, we know some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
The thousands of women who make up the Facebook community known as Essure Problems, heralded this latest move by the FDA.
“The Essure Problems Administrators, along with over 36,000 members of their online support group, were excited to read today’s FDA announcement restricting the sale and distribution of Essure in the United States,” the group announced on Facebook.
“This is a unique restriction, and it will help resolve the issue we brought up with Commissioner Gottlieb, that almost 95% of women implanted after the FDA’s guidance was issued were not getting the new warnings about Essure. . . . While it does not take Essure off the shelves, it certainly holds Bayer accountable to train doctors on the true risks of this device and mandates that doctors must share the black box warning and patient checklist with women considering Essure.”
The administrators consider this to be the “first step” the FDA has taken that actually benefits women over industry and are “eager to see how Bayer plans to comply with these new requirements which severely restrict their sales of Essure to providers who diligently follow the disclosure protocol for the product.”
The FDA ordered Bayer to conduct a post-market clinical study in 2016, a project that is ongoing, but the effort could ultimately prove futile because the product has already seen a 70 percent decline in sales in the U.S.
“We highly doubt any hospital or medical facility will want to endure the risks of purchasing Essure knowing full well that they could now be held accountable and liable if women do not receive complete and appropriate informed consent,” the administrators said. “We anticipate this to be the final nail in Essure’s coffin.”
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