In the News

FDA issues a white paper on the safety of silicone-gel filled breast implants

On June 22, 2011, the FDA issued a white paper on the safety of silicone gel breast implants. The ASPS (American Society of Plastic Surgeons) and the FDA agree that "silicone-gel-gilled breast implants have a reasonable assurance of safety." Both agencies take the position that women with these implants need to monitor them through their lives, since these are not lifetime devices.

The FDA white paper revealed the 90% of patients are satisfied with their outcomes from breast augmentation and noted an improvement in their quality of life.

The collection and evaluation of data in regard to breast implants is ongoing. As always, patient safety is their, and our, first priority.

The related links:

www.fda.gov

The American Society of Plastic Surgeons has posted additional references for members and consumers:

www.plasticsurgery.org

January 27, 2011

We feel that all our patients and all women considering breast augmentation should be aware that the FDA published a press release on January 26, 2011 indicating a possible association between breast implants and a rare form of lymphoma. Please don't panic, because according to the FDA and the ASPS (American Society of Plastic Surgeons), this is what we know:

• ALCL is extremely rare. There are approximately 10 million women in the world with breast implants. Of these, only 34 cases of ALCL (anaplastic large cell lymphoma) have been diagnosed.

• According to the FDA, the risk that a woman with breast implants will develop ALCL is extremely low.

• A woman is more likely to be struck by lightning than develop this problem.

• The FDA and the ASPS remain confident that breast implants are safe and effective.

What you should do if you have or are considering getting breast implants:

• If you have implants, continue your normal routine medical care.
• If you have implants and you notice unusual pain or swelling, contact Dr. Rosenthal or your ASPS Member Surgeon.
• If you are considering breast implant surgery, be sure to discuss potential risks and benefits with Dr. Rosenthal or your ASPS Member Surgeon.

The following is a link to the full FDA news release:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm241090.htm

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm240000.htm

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/
BreastImplants/ucm239996.htm

http://www.plasticsurgery.org/