Breast Implants and ALCL

In the last few days I have received questions from several patients who heard about the U.S. Food & Drug Administration’s recent guidance regarding a possible connection between breast implants and anaplastic large cell lymphoma (ALCL). Both for women who have implants and those who are considering a breast augmentation procedure, I would like to provide more information about this guidance and suggest some next steps.

What the FDA Is Doing

An initial review by the FDA has identified 34 unique cases of ALCL in women with breast implants throughout the world. To put this in perspective, it is estimated that 5 to 10 million women worldwide have breast implants. The FDA believes that women with breast implants may have a very small but increased risk of developing this disease, and is asking health care professionals to report confirmed cases of ALCL in women with breast implants to the FDA.

What the FDA Is Not Doing

The FDA is not taking back its approval of saline and silicone gel breast implants. To quote the organization: “The FDA believes that the totality of evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.”

What You Need to Know

If you have had breast augmentation, I advise you to continue to follow your doctor’s regular implant care instructions. Because ALCL is not a breast cancer, there is no benefit to performing additional self exams, but it is worth talking with your surgeon in more detail if you are particularly concerned, if only for added peace of mind.

For women who are thinking about breast augmentation, it is important to get the latest facts. Additional fact finding on this issue will be ongoing and informed surgeons will be able to give you the most current information while providing additional context for the scientific findings so far.

Tags: alcl, Breast Augmentation, breast implants

This entry was posted on Monday, January 31st, 2011 at 10:17 pm and is filed under Plastic Surgeon,Breast augmentation,Breast Implant,Breast,General Plastic Surgery. You can follow any responses to this entry through the RSS 2.0 feed.