Devices

Alert Issued on Hologic’s BioZorb Markers

An FDA safety alert is warning patients and healthcare providers about the potential risk of serious complications with Holigic’s BioZorb Marker and BioZorb LP Marker devices, which are implanted in soft tissue (e.g., breast tissue) where the site needs to be marked for future medical procedures, such as breast cancer radiation.

FDA says the alert is based on reports that describe adverse events with use of the devices in breast tissue, including infection, fluid buildup, device migration, device erosion and breaking through the skin, pain, discomfort, rash, and other complications possibly associated with extended resorption time (resorbable component of the device not resorbing in the patient’s body for several years). The agency also says it is aware of literature reports describing similar adverse events including the device breaking through the skin of the nipple and the device moving out of position from where it was implanted.

The alert advises healthcare professionals to monitor patients who have an implanted BioZorb Marker or BioZorb LP Marker for signs of any adverse events.

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