The FDA has a new warning out about breast implants. The U.S Food and Drug Administration has identified a possible link between implants and the development of a rare type of cancer called anaplastic large cell lymphoma. The FDA isn't warning women to remove their breast implants out of fear of anaplastic large cell lymphoma. Experts advise to have normal check-ups and watch for the warning signs which include swelling, pain, lumps or asymmetry.
This illustration shows the typical location of the ALCL that was diagnosed in patients with breast implants. ALCL is lymphoma, a type of cancer involving cells of the immune system. It is not cancer of the breast tissue.
Public Citizen, a consumer watchdog group, indicates that the FDA did not go far enough in warning women about the risks associated with silicone breast implants, suggesting that women should be advised against having the implants. Public Citizen also pointed out that the report comes just months after the FDA warned that both silicone and saline breast implants could be linked to lymphoma.
The FDA issued new safety data for silicone breast implants, indicating that the agency has found no link between the breast implants and breast cancer. Although the agency said that the silicone implants have a “reasonable assurance of safety”, they also indidicated that “the longer a woman has (silicone) breast implants, the more likely she is to experience local complications or adverse outcomes.”
The FDA has acknowledged that while there appears to be no link to breast cancer, there are other common side effects and complications with silicone breast implants, such as ruptures, scarring, tightening of the skin around the implant, pain and infections. Despite these problems, the agency has determined that silicone implants are safe and effective when used properly, but the FDA is continuing to gather data.
In 2006, the FDA allowed silicone gel-filled breast implants to return to the market after having requiring a silicone breast implant recall in 1992 due to a failure by manufacturers, Allergan and Mentor Corp., to turn over requested clinical trial data and suspicions that the implants could cause breast cancer. The FDA’s subsequent studies found no links to breast cancer and the manufacturers turned over preliminary trial data, allowing for their return to the market.
In January, the FDA also warned that both silicone and saline breast implants may be linked to a form of cancer known as anaplastic large cell lymphoma (ALCL). After the FDA issued the warning, the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) put up an online video, urging plastic surgeons to downplay the FDA warning and avoid using the word cancer.
Public Citizen called on the FDA to take action. The information was taken down after the FDA contacted the two groups. Public Citizen said that the incident highlights concerns that women who participate in studies or receive breast implants may not be adequately educated enough to provide informed consent.
If you want to learn more about breast implants and ALCL, visit FDA’s Center for Devices and Radiological Health. If you have breast implants and have been diagnosed with ALCL, submit an online report through the agency’s MedWatch program online or call 1-800-332-1088. All reports are confidential.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.
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