SPRINGFIELD — Mercy Medical Center plastic and reconstructive surgeon Dr. Brian A. Pryor called the Food and Drug Administration’s concurrence Tuesday of a link between a rare form of cancer and breast implants “significant,” and further indication of the need for ongoing patient education around the procedure.
“Any negative ramification from any cosmetic or reconstructive surgery is significant and not something to be dismissed,” Pryor said.
He termed any such ramification, in this case the FDA saying it had nine reports of deaths from breast implant-associated anaplastic large cell lymphoma, a rare type of non-Hodgkin’s lymphoma, “another layer of discussion to have with patients.”
“Two weeks ago, I spent a significant amount of time talking about the benefits and risks of breast augmentation with a patient to help her put them in perspective and make an educated decision on whether to proceed, keeping in mind the FDA and American Society of Plastic Surgeons recommendations,” Pryor said.
He added that he was not surprised by the FDA’s announcement, saying that both the FDA and ASPS have been tracking an association between breast implants and the rare T-cell lymphoma since 2011. He called it an “update” on existing literature and registries tracking the association worldwide, and noted that neither organization has changed its recommendations on implants as a result of Tuesday’s announcement.
In making its announcement, the FDA said, “Since 2011, we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants.”
It called such a risk “very low,” although higher for women with implants, but said women with breast implants have “no need to change your routine medical care and follow-up,” but to “contact your health care provider promptly to schedule an appointment” if they notice any changes.
Pryor noted the number of cases reported to the FDA with BIA-ALCL range “between 220 and 300 cases” out of “some 10 million breast implants that have been installed or placed in the world.”
“With every surgery and treatment options it is important to educate patients and help them understand the facts,” said Pryor, adding that his patient decided to go ahead with breast implants.
“The number 220 to 300 patients is very significant for those patients diagnosed with BIA-ALCL, but you put that in the perspective of the number of breast implants in the world today.”
Pryor noted that the instances of the rare cancer linked to breast implants was higher for implants with textured surfaces, which are less common in the United States than elsewhere, and also that the incidences of cancer were diagnosed 10 years after the implants were done.
Pryor, who uses only smooth surface breast implants, speculated that textured ones may interact more with the body. It is in the fluid around an implant that cancer cells were detected. Treatment involves removal of the implant as well as the fluid-filled area called the capsule and, in some cases, radiation and chemotherapy.
Pryor said he does about 50 breast implants annually, the majority involving breast cancer patients wanting reconstructive surgery.
Pryor said he tests capsule fluid whenever he exchanges or modifies a breast implant and said he has never had a patient test positive for ALCL, a type of cancer that Pryor said can also be found in individuals who have never had a breast implant.
Similar comments about an ongoing awareness of an ALCL association with breast implants were echoed by Dr. Pranay Parikh, Baystate Medical Center’s chief of plastic surgery, as well as on the importance of patient education about any possible risk.
“To date, I have not treated any patients at Baystate for this disease, and in my career as a plastic surgeon, I have not personally seen a single case,” Parikh said.
“However, because we are aware of BIA-ALCL, we always consider it as a potential diagnosis in cases of late fluid buildup around implants, and have the tools and testing needed to diagnose and treat the disease once identified.”
Parikh added, “Women considering implants deserve choices and need the best information we can give them.”
“We pride ourselves on providing safe, quality care for our patients, and have long counseled people seeking breast implants about the benefits and risks, including for developing ALCL, so that every patient can make an informed decision about what is right for them,” Parikh said.