The FDA announced that nine deaths from a rare form of cancer are linked to breast implants with pebbly surfaces. As of Feb. 1, the agency received 359 medical device reports of anaplastic large-cell lymphoma (ALCL) with the implants.
In 2011, the FDA identified a possible association between breast implants and the development of ALCL cancer, a rare type of non-Hodgkin’s lymphoma. At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk.
Of the 359 reports including nine deaths, 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. Most of the reports contained no information about the surface textures of any previous implants.
In 2016, a total of 290,467 women received breast implants, according to the American Society of Plastic Surgeons. ALCL is a very rare condition; when it occurs, it has been identified most often in patients undergoing implant revision operations for late onset, persistent seroma (a collection of fluid that builds up under the surface of the skin).
Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.
In 2016, there were several advances in the description of the disease and treatment recommendations:
- The World Health Organization recognized breast implant-associated anaplastic large cell lymphoma as a rare T-cell lymphoma that can develop following breast implants.
- The Australian Therapeutic Goods Administration (TGA) reported a detailed analysis of the 46 confirmed cases of BIA-ALCL in Australia, including 3 deaths. None of the cases occurred in women with smooth implants. TGA estimated the risk of developing BIA-ALCL to be between 1-in-1000 and 1-in-10,000 women with breast implants.
- The French National Agency for Medicines and Health Products Safety (ANSM) asked manufacturers of textured breast implants to perform biocompatibility testing (testing to determine how living tissues react to textured implants) and to report their findings within a year.
A significant body of medical literature has been published since 2011. Most of the cases in the literature reports describe a history of the use of textured implants. Several recent journal articles explore the risk factors for ALCL, including the methods used to create surface texture of the implant and the role of biofilm in causing disease, among others.
All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants. Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.
The FDA advised doctors to consider the possibility of ALCL with patients with late onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If a doctor suspects ALCL, the patient shoud be referred to an appropriate specialist for evaluation.See the FDA Update for more information, including a summary of Medical Device Reports and medical literature, and recommendations for patient care.