Devices

CDRH Cautions on Breast Implant Removal

CDRH has posted an online statement updating its work in providing information to patients and providers about the safety risks of breast implants and regulatory actions involving implants and their removal. In the statement, CDRH Office of Surgical and Infection Control Devices director Binita Ashar cites a recent article in the journal Plastic and Reconstructive Surgery written by researchers from several cancer centers that describes the evidence on the risk, diagnosis, and management of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and the link to textured breast implants. Ashar says the article also discusses removal of implants and the potential for risk reduction in certain cases, saying that removal should be a shared decision between the patient and the surgeon.

“CDRH welcomes thoughtful, scientific, and transparent public dialog concerning breast implant safety and effectiveness, and we continue to evaluate all available information about BIA-ALCL and other breast implant-related illnesses,” she writes. “Given that the occurrence of BIA-ALCL is uncommon, prophylactic removal of textured implants is not recommended in asymptomatic patients. However, individual patients should discuss possible benefits and risks of removal with their healthcare providers to make an informed decision about their health.”

The post also discusses steps CDRH took in 2019, 2021, 2022, and 2023 to strengthen breast implant risk communication and help those who are considering breast implants to make an informed decision.

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