Devices

Essure Postmarket Study ‘Barely Off the Ground’: Post

A ClassAction.com online post says that a required postmarket surveillance study of Bayer’s Essure birth control device “has barely gotten off the ground,” with only one subject enrolled as of 10/3. The post reports that the company is removing Essure from foreign markets due to “commercial concerns,” but it remains available in the U.S.

The postmarket study was mandated by FDA 2/29/16, at which time CDRH deputy director for science William Maisel said that Bayer was to submit a study protocol within 30 days and begin the clinical trials within 15 months.

“Bayer submitted its protocol and FDA approved the plan,” the report says. “The study should have started in May of this year. But as of 10/3, the study has barely gotten off the ground…. There is only one patient enrolled out of the required 2,400. By FDA’s own admission, the study had only three enrolled sites by the time the clinical trials were to begin.”

The report says FDA has concluded that Bayer has begun the study because it has made the effort to enroll study sites and patients. “Even though the number of each hasn’t changed in five months,” it says, “FDA is satisfied with Bayer’s approach. The final report from the study is due 9/2023…. Granted, the one patient currently enrolled may be providing data, and subsequent enrollees between now and 5/2020 may do the same. However, the fact remains that Essure, a dangerous medical device, will not only remain on the market until completion of the study, but will do so with FDA’s full blessing.”

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