Breast implants have been linked with an indolent form of non-Hodgkin's lymphoma in a small number of women -- a concern that has stirred up considerable controversy and charges that plastic surgeons may be misleading patients about the safety of the devices.
In January, an FDA review drew attention to reports of anaplastic large-cell lymphoma (ALCL) in 34 women with implants, but advised that the disease was rare and the risk was minimal.
"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.
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But less than a month later, Dr. Sidney Wolfe and Dr. Michael Carome of Public Citizen contacted the FDA with information about a webinar sponsored by two plastic surgery organizations in which they advised their members to minimize the risks of ALCL among women with implants -- referring to it as a "condition" rather than a "cancer" or "tumor."
The organizations, the American Society for Aesthetic Plastic Surgery and and the American Society of Plastic Surgeons (ASPS), denied trying to mislead patients, explaining that their intent was to help surgeons appropriately advise patients.
"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.
The ASPS also has agreed to work with the FDA to establish a breast-implant registry to track adverse events more closely.
Some answers to the controversy may be coming.
Monitoring Adverse EventsA systematic literature review on ALCL and implants prepared by the RAND Corporation and led by Dr. Soeren Mattke of RAND Health in Boston, was published recently online in the ASPS journal, Plastic and Reconstructive Surgery.
"This is the first of two papers, where we review the evidence," Mattke told MedPage Today.
The second paper, expected to appear on the ASPS website in a few weeks, will be more important in that it will summarize the recommendations of an expert panel convened to provide clarification to the questions about implants that have been raised, he explained.
"I believe our work will strongly influence the debate about implants and lymphoma," Mattke said.
"In general, the findings are reassuring, but I can't comment further than that at this time," he added.
The systematic review identified 36 cases of non-Hodgkin's lymphoma in women with implants.
Most were ALCL and typically were characterized by the presence of a seroma in the fibrous capsule that forms around the implant.
Other types of lymphoma in this group included follicular lymphoma, lymphoplasmacytic lymphoma, and Sézary syndrome.
Among patients with follow-up data available, there were no recurrences in 75 percent, and, at last contact, all patients with ALCL were alive.
Anaplastic large cell lymphoma historically has been considered as consisting of two distinct subtypes: systemic disease, with lymphadenopathy and extranodal involvement; and primary cutaneous disease limited to the skin.
Aside from clinical manifestations, the two subtypes differ histologically, with the tyrosine kinase receptor ALK being expressed almost exclusively in the systemic form of the disease, and being involved in pathogenesis through alterations in the ALK gene.
But systemic ALK-negative disease is less well understood, and reports have suggested that five-year survival is less than 50 percent compared with 70 percent in ALK-positive systemic disease.
Yet all the women in this study for whom histologic findings were available were ALK-negative, and no deaths have been reported.
"This is a somewhat surprising finding, given the usual poor prognosis of extranodal ALK-negative cases," observed Mattke and colleagues.
Therefore, because implant-associated ALK-negative disease behaves clinically more like cutaneous than systemic disease, some researchers have suggested that it should be considered a distinct disorder.
In addition, treatment "may therefore only require surgical removal of the affected implant and capsule and clinical follow-up, as opposed to aggressive adjuvant chemotherapy and/or radiation therapy," the investigators suggested.
Limitations of the study included possible inconsistencies in interpretation of pathology findings and underreporting of the condition.