During a January review, the FDA brought attention to reports of anaplastic large-cell lymphoma in 34 women with implants. However, it was noted that the disease was rare as it directly related to implants, and the risks involved was small.
"Because the risk of ALCL appears very small, 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," the agency stated.
Now, less than a month after the fact, Sidney Wolfe and Michael Carome of Public Citizen contacted the FDA regarding a webinar sponsored by two plastic surgeon groups that advised their members to minimize the risks of ALCL among women with implants. Further, the two groups -- the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons -- referred to the risks involved as “conditions” instead of using the words “cancer” or “tumor.”
In response to recent reports on the matter, both organizations have issued the following statements:
"The ASPS and the FDA agree this extremely rare form of lymphoma is not breast cancer. Of the estimated 10 million implants worldwide, only 34 cases of ALCL have been identified since 1989," reads a statement on the ASPS website.
"ASPS shares the FDA's commitment to patient safety, but we also want to make certain this information does not raise false alarms with our patients." the society's president Phillip Haeck, MD, said in a press release.
