Devices

3 Reps Want to Meet with Gottlieb on Essure Study

David McFarland

— 2 min read
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Following Internet blog reports that Bayer has enrolled only one patient of the 2,400 needed for a post-marketing study of its controversial Essure birth control device, three House members led by Rep. Rosa DeLauro (D-CT) have asked for a meeting with FDA commissioner Scott Gottlieb to express their concern about agency inaction on Essure. “Despite widespread safety concerns,” the three write in a 10/30 letter to Gottlieb, “FDA has allowed Essure to remain on the market even while mandating that the manufacturer, Bayer, conduct an additional post-market safety study. However, a year and a half after the study was initiated, it is unclear whether Bayer has acted with urgency to enroll patients, or if the study results will be delayed. FDA cannot continue to allow Bayer to drag its feet on this post-market study while women are continuing to suffer.”

The letter cites a 2015 Government Accountability Office report requested by DeLauro finding that following a post-market safety study request by FDA, companies lack incentives to enroll participants and are slow to report findings. “The Bayer post-market study on Essure has held true to those GAO findings,” the letter says. “In the post-market study plan released by FDA in 3/2016, Bayer planned to enroll 78 patients per month when all approved sites were activated. According to the FDA Web site, there are currently 60 approved sites but only one patient has been enrolled in the study.”

The three say they would like these questions answered in their meeting with Gottlieb: 

  •          what FDA is doing to ensure that Bayer complies with the timeline for recruiting patients outlined in the study plan;
  •          given that Bayer has announced publicly that 100 patients have been enrolled in the study, when the official number of enrolled patients will be released;
  • ·        the number of approved study sites that are actively recruiting patients;
  •          how Bayer is ensuring that potential study participants are informed about the product’s Boxed Warning and how this is being documented; and
  • ·        whether potential study participants will be tested for a nickel allergy before enrolling in the study, whether a decision to decline to implant women with suspect nickel sensitivity will skew the study results, and whether the nickel Contraindication will be added back to the Essure labeling.

“We ask that you enforce accountability measures to ensure that participants are enrolled in the post-market study in a reasonable timeframe in order to complete the post-market study as scheduled so the risks associated with the Essure device will be documented and made public,” the letter concludes.

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