Like many of the women I spoke to, Angie Firmalino, 45, says that her doctor recommended Essure. Shortly after her 2009 procedure, which she says was excruciating, the Tannersville, N.Y., woman began having constant bleeding and pain. She developed joint problems that she attributes to an autoimmune response and had to have surgery to remove the coils. The operation left fragments behind and resulted in a hysterectomy. She’s still dealing with chronic pain, muscle weakness and blood circulation problems, which she also thinks are autoimmune related.

In 2011, Firmalino decided to start a group on Facebook to share her experiences with female friends. Then, strangers started requesting to join and “telling their horror stories, some worse than mine,” she says. Soon the Essure Problems group had hundreds, then thousands of women. They wrote graphic descriptions of their pain and blood loss, fatigue and weight gain; they posted pictures of their thinning hair and bloated bellies that could be mistaken for marking the weeks of pregnancy. And they shared the stranger symptoms: joint pain, sudden muscle weakness, skin rashes. “That’s when the talk started about what is this device made out of?” Firmalino says. “Then we discovered there’s nickel in the device. None of us knew.”

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.”

Another concern for the women involved the nickel. The 2002 package label listed nickel allergy as a “contraindication” (meaning the device should not be used for patients with that condition) and included a directive that physicians screen patients for the allergy. The women learned, however, that in 2011 the FDA granted a Conceptus request that the contraindication be downgraded to a “warning,” which doesn’t require physicians to screen patients. (The current labeling includes a nickel warning. The FDA told me it used a warning rather than a contraindication because it “concluded that the data did not meet the threshold of known hazard.”)

Yet another issue the Essure Problems administrators believe got short shrift was removal of the device. A Conceptus representative testified at the 2002 hearing that taking it out would require cornual resection — removing the area where the fallopian tubes meet the uterus. But doctors have since found that’s “not easy,” says Myron Luthringer, a Syracuse, N.Y., OB/GYN who says he has removed hundreds of the devices. He explains that the coils are fragile and break apart, that the tissue in that area is difficult to repair and that PET fibers have often embedded in the surrounding tissue. For those reasons, he says, he tends to perform a hysterectomy, removing the uterus and cervix, as well as the fallopian tubes. Other physicians do as well. “We really advocate that the right procedure is hysterectomy,” says Paul MacKoul, an OB/GYN at the Center for Innovative Gyn Care in Rockville. But hysterectomy — and cornual resection, for that matter — require the very element many women who chose Essure were trying to avoid: surgery with anesthesia. “Anything that’s designed to be permanent is very difficult to take out,” notes MacKoul’s partner and fellow OB/GYN, Natalya Danilyants.