FDA Warns of Cancer Threat, Calls for Breast Implant Labeling Change

Manufacturers of breast implants will have to update their labeling to warn of a possible link between the devices and a rare form of non-Hodgkin’s lymphoma. In a review of the medical literature, the FDA identified 34 cases of anaplastic large-cell lymphoma associated with the implants from 1997 through May 2010. That number jumped to 60 cases when the agency contacted other regulators, scientists and devicemakers. However, some of the case reports might be duplicates, the FDA said last week.
Devices & Diagnostics Letter