An independent analysis of FDA MAUDE data shows 303 fetal deaths related to the Bayer contraceptive medical device, but FDA itself has only reported five. A U.S. congressman is officially demanding answers while also alleging that some doctors implanting the device received illegal kickbacks.
Something is rotten in the state of FDA’s reporting of adverse medical device events.
That seems to be the gist of the latest salvo Rep. Michael Fitzpatrick, R-PA, has fired against FDA over its handling of dangers surrounding Bayer’s Essure device.
In a letter dated Tuesday to FDA’s top medical device regulator Jeffrey Shuren, MD, Fitzpatrick includes an independent analysis of MAUDE data that shows FDA’s own adverse reporting system listing 303 fetal deaths related to the device. FDA has previously said the number was five. […]
“It looks like the data were reported to FDA but some weren’t flagged as fetal deaths,” says Diana Zuckerman, Ph.D., president of the National Center for Health Research (Washington, D.C.) “One of the questions would be whether ectopic pregnancies were counted as fetal deaths. That’s important because ectopic pregnancies are probably caused by Essure and always result in fetal death. If FDA had decided to count ectopic pregnancies separately from fetal deaths, they should have clarified that.”
Along with the analysis, Fitzpatrick included a previously sealed lawsuit complaint from 2013 that alleges that Conceptus (the original developer of Essure later acquired by Bayer) gave doctors kickbacks to implant the device.
The complaint accuses Conceptus of fraudulently billing Medicare and Medicaid in connection with the Essure device. “Beginning no later than December 2010, Conceptus gave substantial and illegal financial inducements to providers to encourage them to use Essure, a procedure that costs the government almost $3500 per patient.” The complaint also accuses Conceptus of providing OB-GYNs with free medical equipment valued at $20,000 to doctors who implanted 25 or more Essure devices. In addition, the company is accused of provide OB/GYNs with free marketing and advertising services to further increase use of the device while these doctors also received reimbursement from government healthcare programs. […]
One the other controversies surrounding the Essure device is the clinical trial used to help the device win PMA approval in the United States, although this was not specifically mentioned in Fitzpatrick’s aforementioned letter. “I have been quite outspoken talking about my concerns that the company did not accurately report adverse events such as pain in the clinical trial used for the Essure PMA,” Zuckerman says. In the case of Kim Hudak, the clinical trial participant who has obtained her records from the trial, “it is very clear that the clinical forms didn’t accurately represent her experience and that they did not list many painful complications. Whether the information was intentionally omitted or there were a series of mistakes made by people filling out the firms, either way, it resulted in inaccurate information that made the Essure device seem safer than it really was. What made it worse for Kim is that she was told repeatedly that her complications were unrelated to the device. If she had known, she could have had Essure removed years earlier, and she would have not been in such pain for so long.” […]
Another problem is the lack of a control group in the clinical trial used to win PMA approval, Zuckerman says. “The company could have compared patients implanted with Essure with patients who underwent tubal ligation.” A randomized clinical trial would make it easier to track possible side effects of the device. In this case, Conceptus did not accept that the pelvic pain that some women suffered was related to the device, Zuckerman says. “They just said: well, women have pelvic pain, instead of scientifically comparing whether Essure women were more likely to have chronic pain than women who had their tubes tied.’” The Essure example raises interesting questions about the accuracy of clinical studies used to convince FDA of the safety and efficacy of drugs and devices, Zuckerman says, and “whether the professionals who conduct the studies are trained correctly or if there is pressure on them—internal or external—to do things to please the company.”
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