On August 21, 2020 Allergan reported As part of its safety surveillance efforts, the FDA has published new data on harmful side effects associated with breast implants, including certain cases of cancer as well as what patients have termed "breast implant illness"—a collection of symptoms that can include fatigue, memory loss, confusion, rashes and joint pain (Press release, Allergan, AUG 21, 2020, View Source [SID1234563954]).
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The agency’s analysis covers medical device reports through the latter half of 2019, adding 160 new cases and three deaths due to breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, a cancer of the immune system typically found in the scar tissue and fluid surrounding an implant.
This brings the FDA’s worldwide total up to 733 cases and 36 deaths, including 620 cases tied to implants manufactured by Allergan, the agency said.
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In late July 2019, Allergan launched a global recall of its textured breast implants—including in its Biocell and Natrelle product lines of saline- and silicone-filled implants and tissue expanders—after the FDA saw a spike in BIA-ALCL cases, which the agency has been tracking since 2011.
While the overall incidence of BIA-ALCL is low, the cancer can be fatal if not diagnosed and treated early, according to the FDA, such as with surgery to remove the implant and the surrounding scar tissue or with radiation and chemotherapy.
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"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.
Meanwhile, reports of the systemic signs and symptoms referred to as breast implant illness totaled nearly 2,500 across the 12 months from November 2018 to October 2019, the FDA said.
RELATED: FDA sends warning letters to breast implant manufacturers as safety probe continues
That’s a steep jump from the 1,080 reports the agency received over the decade-plus spanning January 2008 to October 2018. The FDA attributes the increase in part to growing awareness of the condition driven by the press, social media and the agency’s public meetings on the subject.
According to the FDA, the top 10 most common symptoms reported by patients with breast implants include fatigue (49%), brain fog (25%), joint pain (25%), anxiety (24%), hair loss (21%), depression (19%), rash (18%), autoimmune diseases (18%), inflammation (18%) and weight problems (18%).
"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," the agency said.