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Essure Court Cases Move Ahead, Clear Legal Obstacles

Plaintiffs in a lawsuit alleging Bayer’s Essure contraceptive device caused patient injuries filed a revised complaint in California state courts this week. The coordinated proceedings include at least 3,000 patients, though no court date has yet been sent.

Legal Issues Safety

Six-Year Study Will Compare Bayer’s Essure With Tubal Ligation

US FDA has accepted a post-approval study plan by Bayer HealthCare for its Essure permanent sterilization device, which is under intense scrutiny in response to adverse events and charges of clinical trial misconduct. The protocol entails a non-randomized, six-year cohort study comparing Essure-implanted women to tubal ligation sterilization subjects.

Safety Regulation

People Briefs

FDA is seeking industry representatives for device advisory panels; Smith & Nephew CEO begins cancer treatment; and news from TherOX, RAPS and Varian Medical Systems.

Medical Device Strategy

Next Steps For Bayer’s Essure Device Coming In February, FDA Says

FDA will publicly announce actions it will take on Bayer’s Essure permanent birth control device at the end of February 2016 following its full review of the medical literature, adverse events reports, and input received during and after a September 24 advisory panel meeting on Essure, the agency said in a posting on its website.

Medical Device Post Market Regulation & Studies
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