FDA Signs Off on Bayer Study of Essure Following Numerous Adverse Events, Deaths

Posted 02 September 2016 By Zachary Brennan

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The US Food and Drug Administration (FDA) on Friday approved Bayer’s updated postmarket surveillance study plan for its permanent birth control device Essure, which has been linked to four adult deaths, 15 incidences of pregnancy loss and 631 reports of pregnancies in patients with Essure.

Although FDA has not pulled the device from the market, in February the agency required Bayer to add a boxed warning to the device and to conduct a surveillance study.

From 4 November 2002, Essure's approval date, through 31 December 2015, FDA says it has received 9,900 medical device reports related to Essure.

The most frequently reported patient problems during this period were pain/abdominal pain (6989), heavier menses/menstrual irregularities (3210), headache (2990), fatigue (2159), and weight fluctuations (2088). Most of the reports received listed multiple patient problems in each report.

The most frequent device problems reported were patient-device incompatibility (2016) (for example, possible nickel allergy), migration of the device or device component (854), device operating differently than expected (490), device breakage (429), device difficult to remove (280), malposition of the device (199), and device difficult to insert (187). Multiple device problems can also be listed in each report.

In 2015, a study in the BMJ also found that women who underwent hysteroscopic sterilization with Essure were more likely to undergo reoperation compared to women who had tubal ligation.

Rep. Mike Fitzpatrick (R-PA), who is sponsoring a bill that would order FDA to revoke Essure's approval, said it is "unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market … If the FDA is going to order another study, then at the minimum they should take Essure off the market during that time."

In October 2015, Rep. Rosa DeLauro (D-CT) called on FDA to pull Essure from the market.

Bayer Study

The open-label, non-randomized, prospective observational study will look at two groups of 1,400 women between the ages of 21 and 45 years who have not been pregnant within the previous six weeks and who chose to undergo either the implantation of Essure or laparoscopic tubal sterilization.

The final report on the study will come in 2023, though in March 2017, a six-month report will be released and 2 September 2017 a one-year report will be released.

Main safety endpoints to be studied will include chronic abdominal or pelvic pain, abnormal bleeding, allergic reactions and the surgical removal of Essure. Secondary safety endpoints include additional data on bloodwork, pathology, histology and metallurgic testing, while the device’s effectiveness will be measured by its ability to stop pregnancies.

Essure Postmarket Surveillance Study

FDA Review Document Review of the Essure System for Hysteroscopic Sterilization

Re-Evaluation of Case Report Forms Supporting the Initial Approval of the Essure System for Permanent Birth Control

September 2015 Advisory Committee to discuss Essure Safety and Effectiveness

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Categories: Medical Devices, Clinical, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: Essure, Bayer, adverse events, medical devices

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