This analysis includes medical device reports through the end of 2019 to add 160 new cases and 3 deaths due to breast implant associated anaplastic large cell lymphoma, or BIA-ALCL, which is a cancer of the immune system that is typically found in the scar tissue and fluid surrounding the implant. According to the agency this increases their total to 733 cases and 36 deaths, including 620 cases that are tied to implants that were manufactured by Allergan.
Allergan launched a global recall of their textured breast implants in July of 2019 which included Biocel and Natrelle product lines of saline and silicone filled implants and tissue expanders after the FDA identified a spike in BIA-ALCL cases which have been tracked since 2011. While the overall incidence is low, this cancer can be fatal if not diagnosed and treated early with a surgery to remove the implant and surrounding scar tissue or with radiation and chemotherapy, according to the agency.
“The FDA has been diligently monitoring adverse events associated with breast implants for decades and has been working to better understand the quality of life and satisfaction a breast reconstruction patient may experience in order to refine our evaluation of breast implant benefits and risks,” said Binita Ashar, director of the agency’s Office of Surgical and Infection Control Devices.
Reports of the systemic signs and symptoms of “breast implant illness” total close to 2,500 from November 2018 to October 2019, according to the agency. This increase is a big jump based on the 1,808 reports that the agency has received from January 2008 to October 2018; the agency attributes this steep incline in part to growing awareness of the condition being driven by the press, social media, and their own public meetings on the topic.
The most common symptoms being reported by patients with breast implants include; 49% report fatigue, 25% report brain fog and joint pain, 24% report anxiety, hair loss has been reported by 21%, 19% report feelings of depression, 18% report rashes, 18% report developing autoimmune diseases, 18% report inflammation, and 18% report experiencing weight problems, according to the FDA.
“While the FDA doesn’t have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some patients experience systemic symptoms that may resolve when their breast implants are removed,” explains the FDA.
