FDA Begins Investigation of Possible Link ALCL and Implants

Advertisement

Yesterday, the US Food and Drug Administration published a press release requesting health care professionals to report confirmed cases of anaplastic large cell lymphoma (ALCL) in women with breast implants.

The basics of the press release can be found here.

While the FDA notes an awareness of 60 cases, their literature review only identified 34 unique cases of ALCL in women with both saline and silicone breast implants.

While 34 cases of ALCL among an estimated 5 to 10 million women worldwide who have breast implants may be statistically significant, women with implants should not be overly concerned.

There is no need to rush into your doctor’s office to ask for your implants to be removed. There is no need to cancel your scheduled augmentation or reconstructive procedure.

ALCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma that is usually of the T-cell type. The cancer cells express a marker called CD30 or Ki-1 on the surface, and may appear in the lymph nodes, skin, bones, soft tissues, lungs, or liver.

According to the National Cancer Institute, ALCL of all parts of the body (is diagnosed in about 1 out of 500,000 women in the United States. Primary breast ALCL is found in only about 3 out of every 100 million women nationwide without breast implants.

Advertisement

At this point, more data is needed to know the true risk of any association of ALCL and breast implants. The FDA is requesting health care professional 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.

Women with implants should remember ALCL is extremely rare. There is no need to change your routine medical care and follow-up.

For more information from the FDA:
Breast Implant Consumer Information
ALCL and Breast Implants Consumer Article

Update (February 4, 2011)
SunSentinel.com is hosting a live Web chat today, Friday February 4th (1 p.m. EST, noon CST, 10 a.m. PST).
Dr. Seth Thaller, a surgery professor and chief of plastic and reconstructive surgery at the University of Miami medical school, will be the guest on the live Web chat, discussing the science behind the risks of breast implants and ALCL.

Sources
FDA Review Indicates Possible Association Between Breast Implants and a Rare Cancer; January 26, 2011

Breast Implants and Lymphoma Risk: A Review of the Epidemiologic Evidence through 2008; Plastic & Reconstructive Surgery. 123(3):790-793, March 2009; Lipworth, Loren Sc.D.; Tarone, Robert E. Ph.D.; McLaughlin, Joseph K. Ph.D.

Anaplastic large-cell lymphoma in women with breast implants; JAMA. 2008;300:2030-2035; De Jong D, Vasmel WLE, de Boer JP, et al.

This page is updated on May 12, 2013.

Advertisement