U.S. FDA announces link between breast implants and ALCL

The U.S. Food and Drug Administration today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma, a very rare type of cancer.

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." The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.Source: fda

Advertisements
This entry was posted in Uncategorized. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s