FDA issues safety signal on ALCL & breast implants
The Food and Drug Administration (FDA) on Jan. 26 issued a communication to inform health care practitioners and the public 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. ASPS has been actively engaged with the FDA on this matter and is collaborating with the Agency to develop a centralized registry to collect more information on existing case reports and any new cases that may be identified.
Noting that the FDA is aware of between 34 and 60 case reports of ALCL among as many as 10 million women with breast implants worldwide (based on a review of scientific literature from January 1997 through May 2010), FDA Deputy Center Director for Science, Center for Devices and Radiological Health Bill Maisel, MD, emphasized during a media teleconference that ALCL is quite rare.
"Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms, such as pain, lumps, swelling or asymmetry," Dr. Maisel said. "These symptoms developed long after the initial surgery had been performed and after the surgical sites had fully healed."
Dr. Maisel added that symptoms may be caused by several factors, including collection of the fluid around the implant (peri-implant seromas), hardening of the breast area around the implant (capsular contracture) or lumps/masses discovered around the implant.
"ASPS shares the FDA's commitment to patient safety, but we also want to make certain this information does not raise false alarms with our patients," says ASPS President Phil Haeck, MD. "We've been down this path before. For nearly 20 years American women were denied access to their choice of breast implants because of false claims and unfounded science. We are determined this shouldn't happen again."
Appearing on multiple local and national newscasts after the FDA announcement, Dr. Haeck further reassured the public of the safety of breast implants and the extremely rare incidence of ALCL.
"Breast implants are the most studied device in the history of medicine," Dr. Haeck said. "Both the FDA and ASPS believe that implants are safe and effective, and there is no reason to change what we're doing now.
"A woman with breast implants has about the same chance of being hit by lightning as she does coming down with this condition," he added.
ASPS and the FDA recommend that women with breast implants should continue their normal routine in medical care and follow-up, specifically regular self-examination and mammography when appropriate. Women with breast implants should watch for changes in their breasts such as pain and swelling, and contact their plastic surgeon if they have questions.
For plastic surgeons, the FDA recommends testing for ALCL if a patient has a late onset and persistent fluid around the implant.
"By sending a sample of this fluid to a pathology lab, a health care professional can test for ALCL," Dr. Maisel said. "Women with breast implants who are not showing any symptoms or problems do not need to change their health care routine. ALCL is rare and has occurred in a very small number of women when compared to the millions of women who have breast implants. The FDA is not recommending the routine removal of breast implants in patients without symptoms or other abnormalities."
The Agency has posted two resources on its website. The first is a Safety Communication that provides a summary of the issue, recommended actions for physicians and patients, and how to report information to the FDA. The second is a more detailed report of the FDA's preliminary findings and analyses on ALCL in women with breast implants. Following the signing of a Confidential Disclosure Agreement with the Agency, ASPS was asked by the FDA to comment on both documents. Working with both internal and outside scientific experts, ASPS provided extensive comments, some of which are reflected in the final documents.
The FDA has provided the following documents on its website:
FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants
Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings & Analyses
The Society is also executing an aggressive media relations campaign to represent plastic surgery's view and minimize potential false alarms for patients and consumers. ASPS has posted additional resources for members and consumers on its website.
"Women who are considering breast implant surgery should do their homework to see if it is right for them," Dr. Haeck says. "ASPS is committed to helping women make informed choices about their health care and our website, plasticsurgery.org, is an excellent resource."
In March 2010, PSN reported on a joint effort between ASPS and ASAPS to convene an advisory council of experts from plastic surgery, epidemiology, pathology, oncology and the FDA to further study anecdotal case reports of the abnormality. The impetus for this effort came from reports by Garry Brody, MD, professor emeritus at the University of Southern California, who has sought to identify common factors among the patients. Dr. Brody presented data at the American Association of Plastic Surgeons annual meeting in San Antonio, Texas, in March 2010.
The FDA is requesting health care professionals to report all confirmed cases of ALCL in women with breast implants to Medwatch - the FDA's Safety, Information and Adverse Event Reporting Program.
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