TMC PULSE

t m c » p u l s e | m ay 2 0 1 9 4 By Shanley Pierce T he U.S. Food and Drug Administration (FDA) recently held a two-day hearing on the long-term safety of a specific type of breast implant that is linked to a rare cancer that grows in the scar tissue around the breast, known as breast implant associated- anaplastic large cell lymphoma (BIA-ALCL). The FDA reported 457 confirmed cases of BIA-ALCL in the United States, all linked to textured breast implants. For women in the U.S. with textured implants, the current lifetime risk of BIA-ALCL runs between 1 in 3,817 and 1 in 30,000. "It's devastating," said Alan Matarasso, M.D., president of the American Society of Plastic Surgeons (ASPS). "But we have to recognize that this is a device, and as much as we study it and as much as we try to perfect it, it adds a third factor into the equation of surgery. It goes beyond just the patient and the surgeon; it [includes] the device. … We have to look at this and study this to get our arms around it." The rough surface of textured implants allows them to adhere to surrounding tissue, which makes them less likely to become repositioned in the implant pocket. Smooth implants, on the other hand, settle faster in the body and tend to create a more natural look. The FDA and the ASPS maintain that breast implants are safe devices. Although France recently decided to ban textured implants, most of the 19 panelists at the FDA hearing and many experts in the medi- cal community say a similar measure in the U.S. would be premature. Symptoms can look like other illnesses Common symptoms of BIA-ALCL include pain, a swelling or hardening of the breast due to fluid collecting around the implant and a discrete mass or lump in the breast or armpit. These symptoms are similar to other, more common, conditions and are more likely indicative of other issues or ill- nesses, said Sebastian Winocour, M.D., assistant professor in the Michael E. DeBakey Department of Surgery at Baylor College of Medicine and member of the Dan L Duncan Comprehensive Cancer Center at Baylor. "Infections or sterile seromas … are far more frequent than ALCL," he said. A woman with symptoms should talk to her physician, who can perform a physical exam and order tests—including magnetic resonance imaging and ultrasounds—to check for any suspicious lumps or swelling. In the presence of fluid or a mass, a physician will then perform a needle biopsy to test for BIA-ALCL. No testing or screening is available to women who are asymptomatic. If caught early, BIA-ALCL is completely curable by removing the implant and the surrounding scar tissue. BIA-ALCL causes are still unclear The direct cause of BIA-ALCL is still unknown, but doctors and scientists are focusing on implant texture, bacterial con- tamination and geographical location. Patients with smooth implants who develop capsules of scar tissue around the implants sometimes opt to replace them with textured implants, which have been shown to reduce the risk of scar formation. BIA-ALCL has been found most frequently in patients undergoing implant revision operations for persistent seroma—a fluid-filled pocket that often develops after surgery, according to the FDA. In addition, some studies have shown that bacteria in the breast lymphoma trig- gers a long-term inflammatory response, Winocour said. Researchers have also identified a possi- ble geographical and genetic variability in BIA-ALCL cases. For example, Australia and New Zealand reported a higher incidence of BIA-ALCL than the U.S., with a 1 in 1,000 to 1 in 10,000 risk with textured implants. "All three of those factors are at this point associations. They're not causations," Winocour emphasized. Textured breast implants linked to cancer BREAST IMPLANTS AND BIA-ALCL Source: American Society of Plastic Surgeons * As of 4/12/19 based on FDA report. 550,000 total breast implants are placed per year in the U.S., including 70,000 textured breast implants • 457 confirmed cases of BIA-ALCL in the U.S. • 9 known deaths* in the U.S., may be attributable to BIA-ALCL Textured breast implants offer a different feel and mobility compared to smooth implants.

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