FDA Confirms Link Between Breast Implants and Increased Risk of Cancer
The Food and Drug Administration (FDA) has updated its 2011 findings of a link between breast implants and the onset of a rare type of non-Hodgkins lymphoma after conducting additional research and analysis of hundreds of reports of women developing anaplastic large cell lymphoma (ALCL) in connection with breast implants. In 2011, the FDA was only able to locate a limited number of cases, but now 359 cases have been identified, including 9 deaths. These numbers are likely only a small fraction of the actual number of existing cases, as the FDA notes that, “The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.” Thus, the identified number of women developing ALCL after receiving breast implants may rise significantly in the months and years to come.
The FDA’s report concurs with findings released in 2016 by the World Health Organization, which found that, “A number of studies in recent years have identified a unique form of ALK− ALCL arising in association with breast implants designated as breast implant–associated ALCL.” Health officials in France and Australia have also identified the risk of ALCL in women receiving breast implants and are continuing their research into the area.
Textured Breast Implants May Present Higher Risk of ALCL
The FDA’s report concludes that, while it will continue to collect information connecting ALCL and breast implantation, “at this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.” Of the 359 reports reviewed by the FDA, 231 included information relating to the type of breast implant. Of those, 203 of the breast implants had textured surfaces and 28 had smooth surfaces. Furthermore, 312 of the reports included information on implant fill types, with ”186 reported implants filled with silicone gel and 126 reported implants filled with saline.”
The report also found that with most cases of ALCL associated with breast implants, the affected patients were undergoing implant revision operations for late onset, persistent seroma. Symptoms associated with this condition include:
Contact Kristy Arevalo at McCune Wright Arevalo If You Have Concerns
The premier complex litigation attorneys at McCune Wright Arevalo in California’s Inland Empire have decades of experience in championing the cause of victims injured by defective medical devices and drugs. Partner Kristy Arevalo, who heads the firm’s defective medical devices and drugs department, has been a leading figure in the fight on behalf of women injured by defective medical devices, including representing 200 women injured by the Essure birth control device. If you believe you are experiencing any signs of health complications following a breast implant procedure, contact Kristy today at 909.572.8019 to schedule a free consultation regarding your circumstances.