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Overview: Breast Implant Illness
The term breast implant illness is often used in reference to anaplastic large cell lymphoma (ALCL), which is a type of non-Hodgkin’s lymphoma. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an immune system cancer that most often is found in the scar tissue and fluid in close proximity to the implant.
So far, this otherwise rare cancer is associated mainly with people who have received textured breast implants.
Discovery of Breast Implant Illness
The U.S. Food and Drug Administration (FDA) found a potential link between breast implants and the development of ALCL in 2011. Due to a limited number of reported cases, the FDA could not pinpoint the commonality among the patients at that time.
Development of Evidence
The World Health Organization declared in 2016 that breast implant-associated anaplastic large cell lymphoma is a T-cell lymphoma that can develop in patients who receive breast implants.
WHO said the number of cases remains elusive due to the lack of reporting of breast implant sales around the world.
The FDA tracks reported incidents of adverse reactions of medical devices, and had received 457 medical device reports as of Sept. 30, 2018. That number includes nine patient deaths.
Other parts of the world are gathering statistics, too. Forty-six confirmed cases of breast implant illness included three deaths, according to the Australian Therapeutic Goods Administration.
In France, the French National Agency for Medicines and Health Products Safety has requested all makers of textured breast implants conduct biocompatibility testing and report their results to the agency. These tests are intended to show how human tissue reacts to the textured implants. France has since banned macrotextured and polyurethane implants due to their link to a heightened risk of cancer.
Worldwide, a total of 17 deaths have been attributed to BIA-ALCL.
FDA Warns Breast Implant Manufacturers
The FDA has not taken textured breast implants off the market, but it has taken less heavy-handed steps.
The FDA warned Mentor Worldwide LLC of Irvine, Calif. and Sientra, Inc. of Santa Barbara, Calif. in March 2019 that the companies needed to conduct post-approval studies to evaluate the long-term safety and possible risks of breast implants. The FDA said the pre-market clinical trials did not sufficiently track the long-term effects.
Mentor Worldwide was specifically told that its post-approval study for the company’s MemoryShape breast implant on the market since 2013 had an inadequate number of patients enrolled. Mentor also was faulted for failing to properly follow up with those patients who did participate in the post-approval research.
The FDA told Sientra that its Silicone Gel Breast Implants, also initially approved in 2013, were inadequately tested post-market because of poor follow-up rates with patients.
To further monitor breast implant illness occurrences, the FDA has partnered with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to create the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology.
Patients who have received textured breast implants should be aware of the following symptoms that could indicate BIA-ALCL:
- Breast pain;
- Swelling around implant area;
- Lumps in the breast or armpit;
- Changes in breast appearance;
- Fluid retention in breasts;
- Skin rash;
- Hardening of the breast.
The FDA says BIA-ALCL can be identified through pathology tests run on fluid and biopsies. The doctor will run tests specifically looking for CD30IHC and anaplastic lymphoma kinase (ALK) markers.
