Devices

FDA Alert on ‘Breast Implant Illness’

An FDA notice is alerting healthcare professionals and patients about medical device reports (MDRs) detailing “breast implant illness” with a variety of systemic symptoms that have been reported following reconstruction or augmentation with breast implants.

“These symptoms include, but are not limited to, fatigue, problems with memory or concentration (brain fog), joint and muscle pain, hair loss, weight changes, anxiety, and depression,” the agency says. “The appearance of such symptoms has been reported with all types of breast implants regardless of filling, shape or surface characteristic, and the symptoms appear anywhere from right after implantation to years later.”

The notice says that while some patients have reported symptom improvement or resolution following removal of the implants, the cause of the symptoms and the degree to which they may be related to the implants are unclear at this time. “Research continues to be performed to better understand any potential association between these symptoms and breast implants,” it says, adding that the agency is continuing to monitor MDRs and will provide updates as warranted.

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