Date Issued: February 20, 2024 — U.S. Food & Drug Administration The U.S. Food and Drug Administration (FDA) is reminding sponsors of device studies and manufacturers of devices (“device firms”) to carefully evaluate…

A new analysis by the U.S. Food and Drug Administration reveals a comprehensive list of the most commonly-reported systemic symptoms in women with breast implants. Other matters of interest to women with…

The U.S. FDA on Thursday reminded healthcare providers that “there are no surgical mesh products cleared or approved by FDA for use in breast surgery, including in augmentation or reconstruction.” The regulatory…

“Dr. Nagel, you kind of answered in your presentation the FDA’s efforts towards breast implant safety registry’s tracking but maybe I could just ask a clarification question based on your presentation, with…

For Immediate Release: September 08, 2022 Statement From: Today, the U.S. Food and Drug Administration issued a safety communication informing patients and providers about reports of squamous cell carcinoma (SCC) and various lymphomas located…

U.S. cases of a cancer linked to breast implants may be well more than double what the FDA previously estimated, says new research from Columbia University. Breast anaplastic large-cell lymphoma (ALCL), is…