Two plastic surgery groups have removed information that downplayed the risks of a rare type of <“https://www.yourlawyer.com/topics/overview/Breast-Implant-ALCL-Lymphoma-Anaplastic-Large-Cell-Lymphoma-Lawsuit-Lawyer”>lymphoma linked to breast implants, following a discussion with the U.S. Food & Drug Administration (FDA). The group Public Citizen had complained to the FDA about the way the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) had characterized the association between breast implants and anaplastic large cell lymphoma (ALCL) last month.
As we reported previously, Public Citizen had sent a letter to the FDA alleging that the ASPS and ASAPS urged their members to downplay the cancer risks of breast implants in a members-only webinar held on February 3. Among other things, the letter slammed the webinar for advising surgeons to avoid using the words â€œcancerâ€ or â€œtumor,â€ when discussing breast implants with patients. During the webinar, doctors were also told to refer this â€œconditionâ€ as having a â€œbenign courseâ€ and that â€œsurgery is curativeâ€ when speaking to women about breast implants.
In its letter, Public Citizen asserted that the â€œASPS and the ASAPS have ignored the currently available facts from published case reports of breast implant-associated ALC,” pointing out that for most ALCL patients, chemotherapy and/or radiation therapy will be part of the recommended treatment plan.
According to a Bloomberg report, the organizations have removed the webinar from their websites, even though the FDA could not order them to do so.
â€œIt was never our intention to downplay the risk of a very rarely occurring cancer associated with breast implants,â€, a spokesman for the American Society of Plastic Surgeons told Bloomberg via email. â€œWe regret that our word choice caused confusion, and we voluntarily removed the webinar from our website.â€
According to Bloomberg, the FDA does not regulate independent organizations like the ASPS and ASAPS.
ALCL is a rare malignant tumor (non-Hodgkin lymphoma) that may appear in several parts of the body including the lymph nodes, skin, bones, soft tissue, lungs or liver. The FDA recently warned that 60 cases ALCL have been reported in breast implant patients. The agency also said its review of the medical literature published between January 1997 and May 2010 revealed 34 unique cases of ALCL.
According to the FDA, 27 cases of the lymphoma involved silicone breast implants. Most of the ALCL cases were diagnosed after silicone implants returned to the market in 2006. The diagnoses tended to occur a median of eight years after implantation, and involved implants for breast augmentation as opposed to reconstruction following breast cancer surgery.