Dr. Fredric M. Barr, M.D., F.A.C.S. Comments On ASPS Statement on BIA-SCC
(WEST PALM BEACH, FL) — The American Society of Plastic Surgeons® (ASPS) recently commented on the FDA’s safety communication regarding squamous cell carcinoma (SCC) and various lymphomas in the capsule around breast implants.
The FDA statement reads in part, “The U.S. Food and Drug Administration (FDA) is informing the public about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. The various lymphomas reported are not the same as the lymphomas described in previous FDA Communications as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The FDA learned about these reports through our continual postmarket review of breast implants and our ongoing collaboration with external stakeholders.
“While the FDA believes that occurrences of SCC or various lymphomas in the capsule around the breast implant may be rare, health care providers and people who have or are considering breast implants should be aware that cases have been reported to the FDA and in the literature. Currently, the incidence rate and risk factors for SCC and various lymphomas in the capsule around the breast implants are unknown. When breast implant information was provided, there have been literature reports of SCC and various lymphomas in the capsule around the breast implants for both textured and smooth breast implants, and for both saline and silicone breast implants. In some cases, people were diagnosed after years of having breast implants. Some of the reported signs and symptoms included swelling, pain, lumps, or skin changes.
“This is an emerging issue, and our understanding is evolving. For this reason, the FDA is asking health care providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around the breast implant to the FDA.”
The American Society of Plastic Surgeons® supports the FDA’s recommendation that all confirmed cases of BIA-ALCL be reported to the PROFILE on the Plastic Surgery Foundation (PSF) website, a joint effort of the FDA and ASPS/PSF to collect data on BIA-ALCL.
Furthermore, all confirmed or suspected cases of BIA-SCC will be eligible to report to the PROFILE registry as The Plastic Surgery Foundation expedites its efforts to include BIA-SCC data points. Although the PROFILE is a physician reporting system, patients who would like to report their case directly can contact a physician willing and able to report their case.
Dr. Fredric M. Barr, M.D., F.A.C.S., of Palm Beach Plastic & Cosmetic Surgery in West Palm Beach, Florida, believes this is a welcome development for women suffering from suspected symptoms of Breast Implant Illness (BII). “Although the association between breast implants and hormonal, thyroid, or other autoimmune type illnesses has yet to be definitively and scientifically established by the medical community, I listen to my patients when they report these symptoms,” he says. “Based on the feedback I received, I decided not to perform breast implant surgery in 2019. This recent safety communication from the FDA and their partnership with the ASPS/PSF in creating this PROFILE is a positive step in the right direction for patients dealing with debilitating, unexplained symptoms. I’m grateful for the physicians willing to help women report their cases via the PROFILE. I will continue to listen to my patients and recommend the best course of action for each individual.”
To learn more, visit https://www.plasticsurgery.org/patient-safety/breast-implant-safety#SCC.
About Palm Beach Plastic & Cosmetic Surgery
Headed by Fredric M. Barr, M.D., F.A.C.S., Palm Beach Plastic & Cosmetic Surgery is one of the finest medical and reconstructive surgery providers in Palm Beach County, Florida. With a successful track record of over thirty years in the area, Palm Beach Plastic & Cosmetic Surgery is the surgical specialty that even physicians choose. The practice believes in three basic patient principles of understanding each patient’s unique needs, providing each patient with the utmost care and compassion, and making sure no question or issue goes unaddressed. For those reasons, along with Dr. Barr’s extensive skills and experience, Palm Beach Plastic & Cosmetic Surgery is a premier choice for those desiring to be renewed in beauty and spirit. When it’s time to look anew, look to Palm Beach Plastic & Cosmetic Surgery. With offices conveniently located in West Palm Beach and Palm Beach Gardens, call today at (561) 833-4122.