Devices

FDA Wants Breast Implant Boxed Warning

FDA is recommending that manufacturers of breast implants incorporate a Boxed Warning and patient decision checklist into the device labeling “to better ensure certain information is received and understood by patients.” A new draft guidance, Breast Implants—Certain Labeling Recommendations to Improve Patient Communication, also recommends updated and additional labeling information, including updates to the silicone gel-filled breast implant rupture screening recommendations, inclusion of an easy-to-find description of materials, and provision of patient device cards that were recommended at a 3/2019 meeting of the General and Plastic Surgery Devices Advisory Panel.

The agency says it has learned that some patients may not be receiving or understanding important information on the benefits and risks of breast implants in a format that allows them to make a well-informed decision about whether to have a breast implantation. “Notably,” the guidance says, “approved labeling for currently marketed breast implants is lengthy, often in excess of 50 pages.”

The guidance says FDA “believes it is important for patients considering breast implants to have the information they need for a balanced discussion with their physician regarding the benefits and risks of breast implants. To help ensure that patients have this information, a Boxed Warning, a patient decision checklist, and a patient information booklet/brochure specific to the breast implant should be provided by manufacturers and given to patients prior to implantation. For those patients who decide to have breast implants, a patient device card should also be provided to patients after surgery. FDA intends to work with manufacturers of new breast implants through the PMA process, and manufacturers of currently marketed breast implants through the PMA supplement process, to integrate these important labeling recommendations.”

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