Devices

FDA Updates Breast Implant/Lymphoma Data

FDA says it is aware from medical device reports of 414 cases of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) as of 9/30/17, including the death of nine patients. The new figure is in an agency online update on BIA-ALCL and agency recommendations for healthcare providers and patients.

A possible association between breast implants and development of ALCL was first reported by FDA in 2011. Since then, the update says, the agency has strengthened its understanding of the condition and the World Health Organization has designated BIA-ALCL as a T-cell lymphoma that can develop following breast implants. “At this time,” it says, “most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.”

The update provides information on the 414 medical device reports and on studies reported in the medical literature. It says that FDA regularly receives and reviews medical device reports, reviews the current medical literature, exchanges information with other U.S. and international regulators and scientific experts, reviews data from a registry, reviews implant manufacturer data, reviews information from ongoing post-market studies, and monitors adverse events from other real-world data.

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