When I started my plastics fellowship in 2010, there was a notion textured implants, which have a rough surface to attach to the tissue surrounding them so they won’t move, were unsafe because there had been a few concerning cases. Since then, I have only used smooth implants on my patients—which are soft and have the ability to move around the pocket—to ensure their health and safety.
Just one year later, in 2011, the Food & Drug Administration (FDA) identified a possible association between breast implants and the development of anaplastic large-cell lymphoma.
This isn’t breast cancer, but a T-cell type of non-Hodgkin’s lymphoma, a cancer of the immune system, commonly found near the breast implant within the fibrous scar capsule. The symptoms of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) can occur years after implants have been placed, and include continuous breast swelling, the presence of a mass, or persistent pain. Patients should immediately see a healthcare provider, who can find collected fluid around the implant, a lump, or a capsular structure.
Although the risk of developing BIA-ALCL is considered low, it can spread throughout the body and eventually lead to death if left untreated. A study published in January 2018 by JAMA Oncology, a peer-reviewed medical journal published by the American Medical Association, found one in 35,000 women at age 50 would develop the cancer, one in 12,000 at 70, and one in 7,000 at 75. In most cases, it’s been successfully treated with surgery to remove the implant and surrounding scar tissue, while some have also needed chemotherapy and radiation therapy.
However, there were so few cases, the FDA wasn’t able to determine what factors increased the risks. After reviewing post-approval study data and medical device reports and opening public discussions about the topic, it ultimately discovered the chances of developing BIA-ALCL greater among those with textured implants.
Currently, the FDA states, “If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL.”
The FDA recommended textured tissue expanders shouldn’t be used due to insufficient evidence about whether the six-month temporary exposure could endanger patients. As for the fill of the implant—silicone or saline—the FDA hasn’t yet ascertained a link.
In December 2018, Europe banned Allergan, the manufacturer of a specific type of textured implant linked to BIA-ALCL, from selling its Microcell and Biocell textured implants. By May 2019, 38 countries including France and Canada had pulled them from the market.
Shortly after a public advisory committee meeting in March 2019, the FDA announced it would not ban these products, but would work to add a black box warning on the labels of textured implants.
In July 2019, the FDA issued a news release stating it had requested Allergan recall models from the United States market. This action came after reports of 573 cases and 33 deaths worldwide from BIA-ALCL, of which 481 involved patients who had Allergan breast implants. Occurrences have also been on the rise, with an increase of 116 new cases and 24 deaths in 2019 alone, according to Yale Medicine, the clinical practice of Yale School of Medicine.
Allergan agreed to recall its Biocell textured implant products including Natrelle Saline-Filled, Natrelle Silicone-Filled, Natrelle Inspira Silicone-Filled, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs were also taken off the market.
The FDA explained it would continue to collect and evaluate data, and offered recommendations for both patients and healthcare providers concerned about this rare cancer. The federal agency urged patients to keep a record of the device manufacturer, know the symptoms of BIA-ALCL, and talk to health providers immediately if experiencing any signs. It also mandated physicians should stop using the recalled implants and return any inventory, inform patients of the risk of BIA-ALCL, and report any known cases. Currently, the FDA states, “If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL.”
Please contact a healthcare provider if you think you have any of the symptoms of BIA-ALCL.
Buglino Plastic & Reconstructive Surgery performs lifts, reductions and reconstructions, and only utilizes smooth implants for breast augmentations. Contact us today to set up your free consultation.
