Devices

Bayer Removes from Market 99% of Essure Devices

A year after Bayer stopped selling and distributing Essure, an implantable contraceptive device, CDRH director Jeff Shuren says the company has repossessed 99% of unused devices in the market. “Additionally, postmarket safety monitoring for women who have Essure implanted remains a top priority for the agency, and today we are announcing that enrollment in Bayer’s required postmarket surveillance study has ended,” he said in an agency update. “Follow-up of patients in the study is ongoing, and the FDA is committed to sharing new information with the public about the postmarket safety of this device as it becomes available.”

As of this month, 1,128 patients have been enrolled in the postmarket study, with 340 enrolled in the group who elected Essure and 788 in the group who elected laparoscopic tubal ligation. As previously announced, FDA instructed Bayer to extend the study from three years to five years to better understand the device’s long-term safety profile. The agency will post interim study results, including information about device removal, once the data are analyzed.

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