Devices

FDA Acellular Dermal Matrix Caution

An FDA safety communication is cautioning patients, caregivers, and healthcare providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction have a higher chance of complications or problems. The online communication says the agency has not cleared or approved ADM or mesh for use in breast reconstruction. “FDA is informing healthcare providers and patients of our recent analysis, and requesting prompt reporting of adverse events to help us better understand the risks,” the notice says.

The notice says the agency recently completed an analysis of patient-level data from real-world use of ADMs off-label for implant-based breast reconstruction and found that FlexHD and AlloMax (both developed from human skin) may have a higher risk profile than others.

The FDA analysis of a Mastectomy Reconstruction Outcomes Consortium study that collected data from 11 centers, including nine academic hospitals, found significantly higher complication rates of explantation, reoperation, and infections in patients with FlexHD and AlloMax brands of ADM two years after surgery, compared to patients who received SurgiMend or AlloDerm brands or no ADM. “This increase in complications associated with FlexHD or AlloMax was seen across multiple sites,” the notice says…. “Physicians should be aware that real-world data suggests some ADMs may have higher risk profiles than others. FDA does not recommend preventive reoperations or removal of implanted ADM. In addition, FDA is not aware of any information that shows an association between ADM use and development of breast implant-associated anaplastic large cell lymphoma. At this time the root cause of the difference in complication rates among different brands of ADM is not known, but healthcare providers and patients should be aware of FDA’s analysis.”

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