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  • The Washington Post, Jennifer Block

The Battle Over Essure

One night in April 2015, Keisha Carney tried to go to bed in spite of a bad toothache, which turned into an even worse headache — the kind that doesn’t let you sleep. “I couldn’t stand still. I was up walking around,” she says. She woke her husband, who called her dentist’s emergency line and then drove to a 24-hour pharmacy for pain medication.

...[S]uddenly lots of “little things” were going haywire with Keisha’s body, the couple recounts for me as we sit in their neat, airy suburban townhouse about 30 miles south of Washington. Her hair was falling out in clumps, she was having unusually heavy periods and severe cramps at odd times in her cycle, she was gaining weight and battling brain fog and severe fatigue — even when she’d slept.

Then, another problem cropped up: Keisha missed a period. This was strange, because seven weeks after her twins were born, Keisha’s obstetrician-gynecologist had inserted a “permanent contraceptive” device called Essure, made by Bayer. Keisha and RW had eight children between them at that point. “God has blessed us abundantly,” says Keisha. “We knew we were done.”

Though Keisha thought she had forever taken care of birth control, the feeling that she might be pregnant kept nagging at her. [...]

So, she picked up a drugstore test to set her mind at ease. When it was positive, “I was devastated,” she says. “My husband had to literally pick me up off the floor.”

After the shock wore off, Keisha went online and found a Facebook group called Essure Problems. [...]

Reading through the posts, Keisha began to think that all the strange “little things” happening in her body might be explained by a reaction to the device she had chosen for birth control. [...]

In order to monitor any potential long-term effects of the device, one of the FDA’s conditions in approving Essure under expedited review was that the company would continue to follow the women from the pivotal study for at least five years. That data, which was submitted in 2008 but not posted by the FDA until 2014, reported that 92 percent of the 384 participants said overall comfort was “excellent” and 97 percent said they were “very satisfied.” But the company noted that 30 percent of the original study group could not be followed for the full five years. [...]

The handful of women administering the group began researching the device and submitting requests for federal records. One of the details that disturbed them was that the Conceptus vice president who presented the application to the Center for Devices’ OB/GYN devices advisory panel, Cindy Domecus, had been an industry representative on that same panel from 1995 to 2001. In 2002, when Domecus appeared before the panel on behalf of Essure, four of the panel’s nine voting members, including the chairman, were people she had served with. (Domecus declined to comment for this article.) When I asked the FDA about Domecus’s tenure on the panel, it noted that industry representatives cannot vote. However, Diana Zuckerman, president of the National Center for Health Research, which scrutinizes industry influence in health care, believes sitting on the panel gives industry members advantages by allowing them to build relationships and gain “a better understanding of how to influence the vote.” [...]

At the Sept. 24, 2015, hearing on the FDA’s Silver Spring campus, 22 women testified about their symptoms and the impact they said Essure was having on their relationships, their sex lives, their ability to take care of their kids and their ability to work. [...]

Fourteen months after the hearing, the FDA announced the black box warning, which alerts patients to reported device migration, perforation, persistent pain and “suspected allergic or hypersensitivity reactions.” [...]

The 16,373 adverse events related to Essure that were reported as of May 31 include accounts of devices that broke apart, migrated out of the fallopian tubes or punctured other organs; there are also reports of systemic autoimmune reactions, pregnancies (about 1,100), miscarriages and stillbirths. There are four reports of adult death, though the FDA notes that “confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.” [...]

Read the original article here.

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