FDA Issues Safety Signal on ALCL and Breast Implants

Healthcare Alert: I thought it best to get this information out right away. Both the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery have advised their members regarding the FDA Safety Signal about a possible association between breast implants and anaplastic large cell lymphoma (ALCL). Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing the condition.

It is important to note as the ASAPS does in today's member advisory...

"This condition is incredibly rare — in the past 25 years only 34 cases have been reported worldwide among an estimated 10 million+ implanted devices. In addition, as opposed to the systemic, nodal pattern of ALCL, in published reports ALCL seen in the presence of breast implants has demonstrated an indolent course: both with women experiencing aggressive systemic therapy as well as those treated with simple explantation and capsulectomy - the condition was resolved."

The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:

• Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online or by calling 800-332-1088.
• Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
• There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, health care providers should follow standard medical recommendations.
• Women should monitor their breast implants and contact their doctor if they notice any changes.
• Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.

The FDA published its literature review in a document posted on FDA’s website site today titled “Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses.”