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.
This represents a 0.000003 - 0.000006% chance of developing ALCL after getting breast implants.
Some comments from The American Society of Plastic Surgeons (ASPS) President Phil Haeck, MD regarding this announcement:
"Breast implants are the most studied device in the history of medicine."
"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."The 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.
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
Call our office today for any further questions you may have regarding this FDA announcement, or any other questions you may have regarding Breast Augmentation or other Cometic Procedures. (904) 990-3477.
