Although the risk for breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) has been well-documented, patients considering breast implants continue to be inadequately informed of the propensity for disease development. Awareness of BIA-ALCL has risen since 2020, but adequate safeguards have not yet been put in place, according to experts in the field.
“There have been efforts made [to ensure patients are informed], but they have not been successful,” Diana Zuckerman, PhD, president of the National Center for Health Research (NCHR), said in an interview with Cancer Therapy Advisor.
The most recent effort to more frontally disclose the risk for BIA-ALCL is a final guidance document released by the FDA on September 28, 2020.1 The guidance, which applies to all breast implants, advised breast implant manufacturers to add a black box warning that mentions the risks associated with breast implants such as BIA-ALCL. In the guidance, the FDA also encouraged manufacturers to incorporate a patient decision checklist in the labeling to “better ensure certain information is received and understood by patients.”1,2 Manufacturers, however, are not required to follow these recommendations.
Zuckerman, who is a member of the Breast Implant Working Group,
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said she was surprised by the FDA’s decision to recommend rather than require these facets of the guidance. “We don’t have the answer to that question other than we have talked to FDA officials who said that at least some of this will at some point be a requirement, but we don’t know when that is,” she said.
With no mandates in place to ensure that patients receive information about the risks for BIA-ALCL—among other breast implant-associated complications—upfront, the industry is left to educate—and this does not seem to be working.
Patient advocates Terri McGregor and Jennifer Cook, both of whom have received a BIA-ALCL diagnosis, discussed a misleading patient brochure that has further contributed to the misinformation about breast implant-associated cancer risk. Sold online by the American Society of Plastic Surgeons (ASPS), the brochure featured the symbol for breast reconstruction awareness—a modified pink ribbon—and the slogan “Closing the loop on breast cancer.”3
The brochure was sponsored by several companies, including 2 prominent breast implant manufacturers, Allergan and Mentor. Though the document encouraged users to “stock up now” ahead of Breast Reconstruction Day,3,4 it notably made no mention of BIA-ALCL—not even on the page that describes the risks and safety issues associated with breast implants.
Conflicts of Interest Cloud Risk Disclosure
BIA-ALCL has been diagnosed in more than 1100 patients with a known history of textured implants worldwide, according to Mark W. Clemens, MD, FACS, a plastic surgeon and an associate professor at the University of Texas MD Anderson Cancer Center in Houston, Texas. Outcomes for affected patients are generally good if the implants and capsule are surgically removed; however, it has taken more than a decade for the disease to gain recognition, translating to a delay in the implementation of the appropriate interventions for removal.5
Eric Swanson, MD, a plastic surgeon at the Swanson Center for Cosmetic Surgery in Leawood, Kansas, told Cancer Therapy Advisor that plastic surgeons’ financial ties to breast implant manufacturers are part of the reason why they have been slow to respond to the issue of BIA-ALCL. “There’s a big problem with conflict of interest in plastic surgery. Once [a person has] taken funds from a company, it is very rare for the taker to be critical of that company,” Swanson said.
Evidence suggests that more than half of plastic surgeons have financial relationships with the industry. A 2019 study revealed that substantially higher payments were made to plastic surgeons who spoke at professional society conferences compared with plastic surgeons in general.6,7 Approximately 13% of these speakers were paid more than $37,000, or 10% of the average plastic surgeon’s salary.7
The impact of these conflicts came to a head during a March 2019 FDA meeting held to discuss BIA-ALCL and other issues related to the safety of medical devices. Several plastic surgeons repeatedly defended the use of textured breast implants and downplayed the risk for BIA-ALCL, assuring attendees that changes in surgical technique could reduce the risk. The surgeons reportedly also alleged that the cancer has been associated with smooth rather than textured implants.8,9
Clemens was one of the few presenters at the FDA meeting to advocate that BIA-ALCL was associated with textured breast implants, specifically. “There has never been a pure smooth case ever reported in any case report, case series, or registry to date when a complete device history was known,” he told Cancer Therapy Advisor. “It’s thought that [BIA-ALCL] is an exclusively textured implant phenomenon.”
Clemens previously consulted for breast implant manufacturers including Allergan and received substantial payments, but when he began to conduct research on BIA-ALCL, he realized that consulting was “incompatible” with the research he was doing and discontinued all consulting work.10
“I have not worked with any company in a renumerated fashion for the past 6 years due to the direction my research took,” he said. “That was an important decision for patients and physicians to have faith in the outcomes that we were reporting.”
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February 08, 2021 at 09:00PM
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Patients Continue to Be Inadequately Informed of Risk for Breast Implant-Associated ALCL - Cancer Therapy Advisor
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