FDA: Bayer's Essure device linked to increase in side effect reports

Essure--Screenshot courtesy of Bayer

Bayer is facing disheartening news for its controversial birth control device Essure prior to an FDA panel meeting to discuss the product's safety, as new analysis by the agency shows a spike in reports from women who had bad reactions to the device.

Reports of problems linked to Essure have increased 20-fold from 2011, rising from 115 that year to 2,259 in 2014, The Wall Street Journal reports. The FDA's analysis mentioned several case reports of women who had allergic or hypersensitivity reactions to nickel that can leach in small amounts from the device, including one where a woman had a "generalized rash unresponsive to steroids" that went away after Essure was removed, according to the WSJ story.

The implant, which consists of a metal and polyester coil implanted in a woman's fallopian tubes, renders a patient sterile and provides an alternative to surgical procedures such as tubal ligation.

The recent reports are not exactly a surefire way to judge the devices' safety, the WSJ points out. Manufacturers, hospitals and the public can let the FDA know about adverse events associated with products, but the reports are often affected by publicity or lawsuits. And while Bayer is not facing overwhelming litigation involving Essure, the device has generated its fair share of controversy.

The FDA has received more than 5,000 complaints about the device since it was approved in November 2002, and most are from after Bayer acquired the product through its $1.1 billion acquisition of Conceptus in 2013. In April, the agency said it would investigate Essure after complaints of fraud during clinical trials of the device and claims of serious side effects.

Bayer is maintaining its products' safety, releasing data in May from a long-term study showing that Essure only caused pelvic pain in 7% of participants in a 5-year follow-up study. "The results of this study, which are consistent with other published literature on Essure, document the extended 5-year effectiveness, safety and tolerability of Essure inserts," Dr. John Nichols Jr., a study investigator, said at the time.

But some experts in the field struck back in a New York Times article, citing results from a long-term trial published in Journal of Minimally Invasive Gynecology which found that only 366 out of 518 original study participants were followed for the full 5 years. And women who were tracked still cited a number of problems tied to the device, including unusually heavy periods and recurrent pelvic pain, the authors added.

Still, Bayer is standing by its product. The company in a letter to the editor said that the NYT article "mischaracterizes" its study of the device. And while there are certain side effects linked to the product, Essure still could be a game-changing product for some women, Patricia Carney, medical director of women's health at Bayer, told the WSJ.

"We also want to know what's going on," Carney said, as quoted by the WSJ. "We, too, are seeing these [adverse] events, but the benefits outweigh the risks."

- read the WSJ story (sub. req.)

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