After using social media to shine a light on potential problems with a permanent birth control device, a group of concerned women finally got the chance to share its concerns with the Food and Drug Administration, in person.
The 7 On Your Side I-Team told you in January about claims of complications with a product called Essure. On Thursday, we caught up with the group as it continued its crusade to try and get the device pulled from the market.
Angie Firmalino and others associated with a Facebook group focused on problems the members say are linked to Essure came to Washington, D.C. Thursday to take part in an official meeting with the FDA. Media were not allowed to attend. The FDA says representatives from its Office of the Commissioner, Women’s Health, Compliance, Chief Counsel and other departments were in attendance.
Firmalino and other representatives of the Facebook group spoke at the meeting, expressing their concerns and experiences with Essure. Thousands of complaints have been logged in the FDA’s database related to the device. Bayer, which makes the product, says “it stands behind the safety and efficacy of Essure.” But for women like Firmalino, voicing the concerns they’ve had for years was a relief.
“It was validation,” Firmalino said. “It’s nice to have some validation that they’re finally listening and they may actually look at this and something may come of this.”
Something already has. After a Citizen’s Petition was filed with the FDA, the agency forwarded it to its Office of Compliance and agreed to investigate. Bayer says it is cooperating with the FDA and will respond to any of the agency’s questions. The company says the petition comes from a law practice already engaged in lawsuits against Bayer.
Dr. Diana Zuckerman, president of the National Center for Health Research, is working with the Facebook group.
She said of the FDA meeting, “They hear a lot of complaints from a lot of different patients. It doesn’t always get anywhere. The impression is they’re really listening.”
Zuckerman says during the FDA meeting the agency heard not only about claims of complications, but also claims of problems with the clinical testing that got Essure on the market more than a decade ago, when it was manufactured by a different company, Conceptus.
“I don’t know what’s going to happen next,” Zuckerman said. “But I do think that the FDA will be following up in a concerted way.”
See original article and video here.