Devices

FDA Counts 294 Essure Pregnancy Losses

FDA says its adverse event data through 12/31/15 show 294 reports of pregnancy loss in patients reporting use of Bayer’s Essure sterilization device. The FDA statement is included in the agency’s response to Rep. Michael Fitzpatrick (R-PA), who has called for the device to be removed from the market. The agency letter challenges the congressman’s statement that it had reported only five pregnancy losses as of his 2/2016 request for an investigation.

“Please note that FDA has consistently and transparently made publicly available adverse events, included pregnancy losses, associated with Essure,” the letter says. “In the agency’s executive summary for the 9/24/15 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee meeting, we reported 125 pregnancy losses, not five as suggested by the recent report included in your inquiry. Our summary covered the period through 5/31/15.” The updated analysis with seven additional months of data brings the total to 294.

In its response, the agency also describes a new post-market surveillance study it ordered Bayer to conduct to provide additional information on Essure risks. And it says it will require a Boxed Warning in the product labeling to help ensure that women receive and understand information about the device’s benefits and risks.

The agency also acknowledges Fitzpatrick’s allegations of illegal kickbacks reportedly paid by Bayer and his request that those allegations be included as part of the FDA review. “FDA does not regulate financial payments or financial relationships between medical device manufacturers and physicians or hospitals, so we cannot address this issue,” the response says.

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