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(HealthNewsDigest.com) – In 2002, the FDA approved Essure, the first – and only – permanent contraceptive device for women, touted as highly effective and nonsurgical. Fifteen years later, there have been more than 16,000 adverse events reported to the FDA, including pain, bleeding, allergic and autoimmune reactions, pregnancies and, ironically, hysterectomies necessary to remove the device. How and why was such a device was approved and why do some want it to stay on the market? Jennifer Block writes in The Washington Post Magazine:
- Nobody can say exactly how many women have had Essure implanted since the device went on the market in 2002. Bayer, which is headquartered in Germany, says that more than 750,000 devices have been sold worldwide and that sales “continue to grow.” (According to data from Essure clinical trials, device insertion fails anywhere from 4 to 12 percent of the time, making actual usage unclear.) In a telephone interview, Patricia Carney, director of U.S. medical affairs for Bayer Women’s Healthcare, pointed to the total sales number as evidence that “hundreds of thousands of women who’ve received Essure … successfully achieved permanent contraception without having to go through an invasive surgical procedure.”
- In recent years, the Food and Drug Administration has received more than 16,000 adverse-event reports about Essure. These are official reports about symptoms, hospitalizations or diagnoses that patients, doctors, hospitals or a device manufacturer believe are associated with a device. They can prompt the agency to order a change in labeling, the addition of warnings or, in rare cases, the removal of a device from the market. Among the reports are nearly 9,000 surgical removals of Essure, mostly by hysterectomy. “That’s a lot of surgeries for a device that’s considered minimally invasive,” says Madris Tomes, a former FDA analyst. Although she and other experts in FDA law and regulation emphasize that there is no magic number of reports that will trigger an investigation, complaints can serve as an important signal to the FDA that it should take another look at a drug or device. (The FDA declined an interview for this article but responded to questions in writing.)
- Much of the U.S. medical community continues to endorse Essure. The American Congress of Obstetricians and Gynecologists opposes the black box warning, citing a lack of “good, solid data,” as Levy puts it. Planned Parenthood, which spoke in favor of the device remaining an option at the 2015 hearing, still offers Essure at 18 affiliates. And many physicians and researchers, as well as the Center for Devices’ OB/GYN panel and Bayer, say Essure should stay on the market while further studies about its effects are conducted, because of the risks posed by the surgical alternative. Health-care watchdogs counter that there are other options available, such as IUDs, as well as vasectomy, which does not pose the same surgical risks as tubal ligation. For its part, the FDA told me that it “continues to believe Essure is safe and effective for many women — but also that some women experience very serious and sometimes debilitating problems.”
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