FDA report links breast implants with squamous cell carcinoma, at least 19 cases reported, Based on published studies, the Food and Drug Administration (FDA) has released a report identifying a link between squamous cell carcinoma (SCC) and breast implants in 19 cases where the disease was detected in the scar tissue around the implant. Of these 19 cases, 3 have already resulted in death.
Lumps, breast pain, and discoloration were some of the most commonly reported symptoms in the cases. While the symptoms were common among patients, there was variation in the time after the implant was first inserted and when the cancer was diagnosed. It took between 7 to 42 years after the initial implant placement for people to be diagnosed. Not only this but the age at which people had been diagnosed also varied between 40 to 81 years.
The type of implant also varied among the diagnosed people. These included both saline-filled implants and silicone implants as well as implants with a smooth or textured surface.
As of mid-January, the agency has also received a total of 24 medical device reports (MDRs) regarding the possible relationship between SCC and breast implants. The limitations of the FDA’s reporting system, however, prevent the agency from counting them all as unique cases since there are possibilities of overlaps. Additionally, injuries and deaths detailed in MDRs typically can’t be definitively linked to a specific cause.
The agency has previously issued a warning about squamous cell carcinoma and various lymphomas forming around breast implants, and this new report acts as an update to it. Of the total 24 MDRs reported, 14 were referenced in last September’s safety notice.
For people with breast implants who have not experienced any symptoms, the FDA does not recommend removing their implants. However, the agency has updated its recommendations for healthcare providers and people considering getting implants.
Firstly, doctors are now asked to inform patients of the risk of developing SCC and various lymphomas in the capsule around breast implants when they are having discussions about getting one. Secondly, if doctors discover any cases of cancer in that scar tissue, they need to inform the FDA immediately. The report sent to the FDA must include the results of any scans performed, treatment plans and outcomes, symptoms, pathology of cancer, and the patient’s breast implant history.
The authority also recommends that treatment plans be developed on a case-by-case basis, “in coordination with a multi-disciplinary team of experts including surgical oncology, plastic surgery, breast surgery, radiology, oncology, and pathology.”
This new development is not to be confused with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a threat the FDA has been aware of since 2011. In fact, three years ago, Allergan recalled its Biocell textured breast implants because of a linkage to BIA-ALCL. There are also restrictions on Sientra, Mentor, and Ideal Implants when it comes to the sale of breast implants. Despite this, as of April 2022, the agency has received 1,130 MDRs for the disease.
According to the American Society of Plastic Surgeons, there were over 193,000 breast augmentation procedures and over 137,000 breast reduction and reconstruction procedures in 2020 alone.
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