February 17, 2016
FDA grossly underestimated harm from permanent contraceptive Essure, lawmaker says
A U.S. congressman and a patient advocacy group said Wednesday a permanent contraception device linked to thousands of adverse events has led to far more fetal deaths than previously reported and that doctors performing the procedure received illegal kickbacks.
Rep. Mike Fitzpatrick (R-Pa.) said in a conference call with reporters that he found it troubling that the U.S. Food and Drug Administration did not act on the complaints it had received until thousands of women who said they had been harmed by the device started publicly announcing their concerns.
“They came together as a group frankly because nobody would believe them, not even their own doctors,” he said.
Madris Tomes, a medical-device reporting expert with Device Events, said she searched publicly available FDA data to find 303 reports of fetal deaths, a stark contrast to the five previously reported by the FDA, the agency responsible for evaluating the device‚s safety and usefulness.
Diana Zuckerman, president of the advocacy group National Center for Health Research, said the vast majority of problems with a device go unreported by doctors and patients. Patients often don‘t know how to report an issue and doctors don‚t always understand the importance of reporting even known side effects.
When data is gathered, analysis by the FDA leaves much to be desired, she said.
“At the risk of sounding flippant, it could hardly be done worse,” she said. “This is literally a system that isn‘t working and that‚s for a number of reasons.”
The FDA said in a statement Wednesday that ensuring the safety of Essure is a high priority.
“To date, the FDA has been examining all available sources of information, including the latest studies, expert input and patients‘ testimony from our panel meeting, and medical device reports to better understand long-term complications,” the statement reads. “We are working expeditiously to conduct an evidence-based review of all available information to inform what future actions may be in the best interest of women using or considering Essure.”
Fitzpatrick also discussed a complaint filed in the U.S. District Court for the Northern District of California that alleges doctors received $20,000 of free medical equipment for agreeing to buy 25 Essure kits.
The complaint also states that manufacturer sales representatives would organize lunches with primary-care providers and OB-GYNs, to generate more referrals to the OB-GYNs who produced the most revenue and advertised the most. The sales team internally referred to such providers as “coin-operated doctors.”
Amanda Dykeman, who had the procedure in 2010, said she thinks the financial incentives likely kept doctors from listening to patients who said they were suffering because of Essure.
“This is a slap in the face to the patients being harmed by Essure,” she said.
Fitzpatrick said he is coming forward with the information before the FDA is expected to release new guidance on the use of Essure later this month so that the agency can take it into account.
Essure can be installed by a doctor at a regular office visit lasting less than an hour. A small, flexible coil is inserted into each fallopian tube, causing scar tissue to form and block eggs from getting into the uterus.
The FDA approved the procedure in 2002 and Bayer bought the device from Conceptus in 2013. Some women who had the device implanted, however, said they suffered from intense pain and heavy bleeding. Complaints also included fetal deaths and uterine perforation.
The FDA issued an alert in June after a search of its Manufacturer and Use Facility Device Experience Database found more than 5,000 adverse-event reports.
In September, the FDA Obstetrics and Gynecology Devices panel said use of Essure should be limited because not enough research has been performed to prove it is safe. The panel took no formal vote, however, and did not take the product off the market as many advocates had requested.
Fitzpatrick, who has introduced a bill requiring the FDA to pull its approval of Essure, sent a letter this week to the director of the FDA Center for Devices and Radiological Health, outlining the findings and requesting an immediate review.
The FDA is pressured to approve devices quickly, often with scant research, and there are few resources left for ensuring the safety of those devices already on the market, Zuckerman said.
“It’s a perfect storm of inadequate safeguards for patients,” she said.
Fitzpatrick was the only House Republican to vote against the 21st Century Cures Act, which includes provisions meant to further speed up approval of drugs and devices, because it rolls back device safety review methods, he said Wednesday.
He has written several amendment to the bill, which he otherwise supports, and hopes they will be considered as the Senate takes up the legislation, he said.
A statement from Bayer said the safety of Essure is supported by more than a decade of research and clinical data.
It said the U.S. Justice Department had investigated the allegations in the legal complaint from California and concluded the investigation without intervention or prosecution.
The company also said it was incorrect to say that births not able to be carried to term after an unsuccessful Essure procedure were fetal deaths. By Shannon Muchmore |