Devices

FDA Posts Interim Essure Study Results

FDA says that interim results of a post-marketing surveillance study of Bayer’s withdrawn Essure permanently implanted birth control device show that Essure patients tend to have higher rates of chronic lower abdominal or pelvic pain and abnormal uterine bleeding compared to women who had laparoscopic tubal ligation as their permanent birth control. In a statement, CDRH Health of Women Program director Terri Cornelison also says patients with Essure had higher rates of gynecologic surgical procedures, including surgery to remove Essure, than patients who had tubal ligation. Pregnancy rates were similar for patients with Essure and tubal ligation, she says.

Essure sales were discontinued in the U.S. in 2018 and it has not been available for implantation in the U.S. since 12/2019. In 2/2016 FDA ordered Bayer to gather more data about Essure’s benefits and compare them to laparoscopic tubal ligation. In 12/2018 FDA required the company to extend the post-surveillance study from three to five years.

While study enrollment has ended, the notice says, the five-year follow-up of patients after their permanent birth control procedure is ongoing and patients are still completing one-year follow-up visits.

Cornelison says FDA is working with Bayer to modify the study to include an additional interim analysis at one year of follow-up after the patients’ procedure, earlier than the originally planned analysis at three years.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome