The FDA came under fire March 25 from women demanding that certain “cancer-causing breast implants” be banned. Breast implant-associated anaplastic large cell lymphoma, known as BIA-ALCL, was the topic at a two-day hearing where the women pressed an FDA advisory panel to recommend more long-term research, bans or restrictions on certain products, and a better informed consent process so women may better understand the risks and benefits of medical devices, including breast implants. Emotions ran high at the hearing as women shared heart-wrenching stories of what they suffered following breast augmentation surgery and the placement of breast implants.
Anaplastic large cell lymphoma (ALCL) is a rare type of cancer of the immune system that historically has been estimated to affect only one in half a million women, but that studies show that number is on the rise. ALCL usually develops in the lymph nodes, skin, lungs, or liver; however, ALCL sometimes develops in the breast area of women with breast implants.
In 2011, the FDA identified a possible connection between certain implants and a heightened risk of ALCL, but at that time the data was not significant enough to deter many women or physicians. Now, after a few more years of additional findings, the connection between the two is becoming more clear. In 2016, the World Health Organization (WHO) confirmed the link between a certain type of breast implant and ALCL. The FDA has so far identified 457 cases of BIA-ALCL, but with over 300,000 women getting breast implants every year, that number could rise.
Charting the Link Between Implants and Cancer
The FDA first reported the link between ALCL and breast implants in early 2011. In 2013, researchers at MD Anderson Cancer Center studied 60 women with breast implants who were diagnosed with ALCL. Since ALCL was believed to only be in one woman in half a million, this was much higher than would be expected. In 2014, the National Comprehensive Cancer Network (NCCN), a nonprofit group of cancer experts, released an oncology standard for surgeons and oncologists worldwide to test for and diagnose BIA-ALCL. In March 2017, the FDA finally updated its website to officially report that breast implants could cause ALCL.
For many years, breast implant companies, plastic surgeons, and the FDA assured women that breast implants were safe. Early reports of a link between implants and some types of cancer was dismissed, even evidence that came from the National Cancer Institute did not prove worrisome to many.
Which Implants Are Problematic?
Both silicone gel and saline breast implants may increase the risk of BIA-ALCL, which may produce one or more of the following symptoms:
- Lumps in the breast
- Hardening around the implants
- Fluid buildup around the implants
In an article in the New York Times, the Associated Press reported that government medical advisers claim it’s just soon to ban a type of breast implant without more information necessary to fully understand this problem. On March 25, the FDA didn’t recommend any immediate restrictions on breast implants after a day reviewing the latest research and hearing people speak who are currently suffering from the cancer likely caused by their breast implants. An advisory committee did, however, indicate the need for a standardized, easily understood consent form that explains the major risks of certain medical devices; the consent form would be thoroughly reviewed by physicians and patients prior to undergoing surgery.
The FDA recommends women with breast implants who are not experiencing symptoms continue to undergo yearly examinations and breast cancer screenings. The symptoms of BIA-ALCL may take as little as one year or as many as 8-10 after implantation to occur. Any women with breast implants should see their doctor for evaluation; there is treatment for BIA-ALCL when it’s caught early.