FDA Warns of Additional Type of Cancer Found in Implant-Related Scar Tissue


In a warning released yesterday, the Food and Drug Administration shared there have been reports of a type of cancer called squamous cell carcinoma and various lymphomas found in the capsule that forms around breast implants. While the number of patients who have been reported to have this cancer in the scar tissue around their implants is low—less than 20 cases—the agency stressed that it’s their duty to inform physicians and those who have or are considering breast implants.

The Numbers

According to La Jolla, CA plastic surgeon Robert Singer, MD, that low figure shows how rare this newly found BIA-SCC, or breast implant related squamous cell carcinoma, really is: “To put it in perspective, it is estimated that there are 20,000,000 to 25,000,000 patients around the world who have had breast implants,” he says.

The FDA identified this information through information placed in the MAUDE database, a site for reporting information to the FDA, explains Louisville, KY plastic surgeon M. Bradley Calobrace, MD: “Because of this reporting, which is a passive process, it is difficult to draw conclusions. These cases could be duplicates, it is often uncertain if the SCC was truly part of the implant environment or just happened in a person with implants or whether the information reported was accurate.”

Reported Symptoms

However, due to the history of breast implants and breast implant related illness, health officials felt the need to share the early findings with doctors and patients. Those who were diagnosed say symptoms included pain, swelling, lumps and skin changes. “From a statement provided by the American Society of Plastic Surgeons, this BIA-SCC seems to be involved with textured breast implants,” explains Eugene, OR plastic surgeon Mark Jewell, MD. “Other reports in the scientific literature report the occurrence of squamous cell carcinoma around dental and orthopedic implants as well. This is not a breast implant issue only.”

Rare Cases

New York plastic surgeon Daniel Y. Maman, MD says the most important thing to understand are the numbers. “So, they’re talking about 15 cases in the entire world out of the millions of women that have breast implants, that’s number one. Number two is, it is well known in the medical literature that chronic scars can develop into squamous cell carcinoma. It’s a well-known phenomenon that every dermatologist or plastic surgeon knows and is always in the back of our mind in regards to scars. If it looks funny, it may be cell carcinoma. What has never been described is the presence of SCC within scar tissue in the breast pocket. I personally don’t think it’s necessarily associated with the implant directly; just chronic scars can become when the cell carcinoma and that’s a known phenomenon.”