January 28, 2011

breast-implantsThe FDA released a report Wednesday regarding recent findings of a link between persons with breast implants and anaplastic large cell lymphoma (ALCL), a rare form of cancer involving the immune system.   The FDA stresses that too few cases (37 identified cases since 1997) of ALCL have been recognized among those with breast implants for them to make a causal link between the two.

A registry of breast implant recipients has been proposed by the FDA and the American Society of Plastic Surgeons in order to identify people with breast implants who go on to develop ALCL.  Clinicians can report confirmed cases to the FDA safety information program, MedWatch.  Physician and FDA scientist, Binita Ashar took part in a Q&A on the FDA website regarding the issue.  He noted ALCL has been identified in those with both silicone and saline-filled implants.

The FDA identified this potential connection through their own surveillance, not from agreed upon post-approval studies by makers of breast implants that have enrolled very few women.  At the present time the FDA is not suggesting people remove their implants, but it is important to understand this recently identified potential risk.

The FDA states the information they will have to share about this link will be solely based upon the number of reports the registry receives.  It will be interesting to see if the increased attention to this issue increases monitoring, and thus case-finding, among breast implant recipients.  However, considering the 5-10 million people worldwide with breast implants and 37 confirmed cases of ALCL among them, is this just another media-hyped story adding to cancer-hysteria?