The FDA issued a press release today concerning an uncommon form of lymphoma (ALCL) that has been reported to occur extremely rarely in women with breast implants. Epidemiologists have been following these reports since 1989 and the FDA press release today issued a summary of these investigations for both patients with breast implants and their physicians:
- There is no evidence of any relationship between breast implants and breast cancer.
- Of the estimated 10,000,000 women worldwide with breast implants, there have been only 34 cases of ALCL ever reported. The known risk of a woman with a breast implants developing ALCL is approximately 1:1,000,000 women. (One in a million chance). By comparison, a woman’s lifetime risk of developing breast cancer is 1:8. These numbers may help you to understand how extremely rare this form of Lymphoma actually is.
- This uncommon form of Lymphoma has been associated with both saline and silicone implants, as well as implants with both textured and smooth surfaces. There has not been however any reported cases of ALCL associated with the newest Form Stable Highly Cohesive Gel implants known as the “Gummy Bears”. Several of the reported cases have yet to be fully diagnosed to determine if they are in fact true Lymphomas. The diagnosis requires an expert Hematopathologist to make the correct diagnosis as ALCL of the breast has been so rarely identified.
- Breast implants have been studied more thoroughly and extensively than any other medical device in history. The FDA announcement clearly states, “The totality of evidence continues to support a reasonable assurance that FDA –approved breast implants are safe and effective when used as labeled”. Plastic surgeons, Manufacturers and the plastic surgical societies have contributed data to the FDA and welcome the initiative to begin a worldwide patient registry of this very rare illness.
- This information is being posted to you to reduce any apprehension you may have of your risks of developing this rare form of Lymphoma, and because many of your friends and relatives may hear news reports and become concerned for your safety. My patients with breast implants for both reconstruction and augmentation are encouraged to continue their annual follow-up visits, just as I have always recommended.
- For further information on this subject please visit:
www.theplasticsurgerychannel.com
www.fda.gov
www.allergan.com
www.plasticsurgery.org
