The FDA notification was issued following a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists and breast implant manufacturers.

The review suggests that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.

The FDA is asking the health professionals to report any confirmed cases of ALCL in women with breast implants.

In addition, the agency has recommended women to monitor their breast implants and consult their doctor if they observe any changes.

In an attempt to ensure that patients receiving breast implants are informed of the possible risk, FDA is working with breast implant manufacturers in the coming months to update the product labeling materials.

FDA Center for Devices and Radiological Health chief scientist William Maisel said FDA is working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help in understanding the development of ALCL in women with breast implants.