The FDA is caught in a tug-of-war between, on one side, thousands of women who believe the Essure permanent sterilization device is dangerous, and on the other, the manufacturer Bayer, which insists that the implant is safe, effective and a “valuable contraceptive option.”
Recently, members of Congress and an independent research body entered the fray.
Essure is intended for women who have decided not to have any, or any more, pregnancies.
Once inserted in a women’s fallopian tubes, the device, made of an expandable nickel-titanium coil with a stainless steel coil inside it, triggers tissue growth, ultimately blocking these tubes and preventing sperm from entering the duct. At least, that is how it is intended to work.
But thousands of adverse reports have been filed with the FDA, delineating complaints such as abdominal pain, bleeding, uterine perforations — and device failure leading to pregnancy. Lawsuits against Bayer involving Essure number in the thousands as well.
In September, Bayer announced it would stop sales of Essure outside the U.S. for “commercial reasons,” telling MedPage Today “there is not as much patient interest in permanent birth control” elsewhere in the world.
Essure’s critics remain skeptical.
In late October, House Democrats sent a letter to FDA Commissioner Scott Gottlieb, MD, blaming the agency for letting Bayer “drag its feet” on a post-market study of the “dangerous” permanent sterilization device.
“This device is a prime example of systemic medical device oversight shortfalls and insufficient enforcement to ensure the safety and efficacy of medical devices,” wrote Rep. Rosa DeLauro (D-Conn.) , Rep. Jan Schakowsky (D- Ill. ) and Rep. Louise Slaughter (D- N.Y.).
They demanded that the agency use “enforcement measures” to compel Bayer to finish its study in a “timely fashion” they wrote, “so the risks associated with the Essure device will be documented and made public.”
While the letter stated “only one patient has been enrolled,” FDA and Bayer said the study had 136 participants as of Oct. 19, 2017.
The Democrats’ letter, dated Oct. 30, 2017, also charged that in more than half of the 18,000 reported adverse events associated with Essure implants, women needed invasive surgery to remove the device due to “pregnancy, auto-immune disease, and device migration leading to organ and tissue perforation,” and “many women” received full hysterectomies. […]
“I think that what’s happened to Essure is not unique to this one product. This is a much bigger problem at the FDA and is related to the FDA’s failure to provide good studies of medical devices,” Diana Zuckerman, PhD, president of the National Center for Health Research, told MedPage Today in a phone interview, speaking of the need for more comparative effectiveness research.
Zuckerman is a member of the PCORI-funded study team alongside Gariepy.
“We know that many women have been harmed by Essure. The question is, are there patients for whom Essure is a better idea than the alternatives?” she said.
In September 2015, the FDA asked an advisory committee to review the data on Essure.The panel made a series of recommendations to improve the knowledge base and communications with patients; it was not asked to vote on whether the device should remain on the market.
Zuckerman spoke at the meeting, telling the panel that Conceptus manipulated the research and re-wrote patient responses.
The consumer group Public Citizen called for the device’s removal at the meeting, saying the device “wasn’t adequately studied” before it was approved. […]
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