ALCL is exceedingly rare in women with and without breast implants. According to the National Cancer Institute, an estimated 1 in 500,000 women per year in the U.S. is diagnosed with ALCL. ALCL in the breast is even rarer. Approximately 3 in 100 million women per year in the U.S. are diagnosed with ALCL in the breast. Others have estimated that the incidence of ALCL in women with breast implants is between 1-3 per million women with implants every year.
How many women with breast implants have developed ALCL?
The exact number of cases is unknown. At the time of writing this article, there have been less than 50 reported cases of ALCL in women with breast implants worldwide. However, it is quite likely that the true number is higher than this due to under reporting.
Is there any causal relationship between breast implants and ALCL?
There is no evidence that breast implants cause ALCL and it may be impossible to ever demonstrate a causal link because the disease is so rare.
What are the symptoms of ALCL in women with breast implants?
The main symptoms of ALCL in women with breast implants have been reported as persistent swelling or pain aound the breast implant. These symptoms were noted to occur weeks to years after implant insertion. A seroma (fluid collection around the implant), palpable mass or capsular contracture (thick and noticeable scar capsule around the implant) have all been reported. It should be noted that these symptoms are far more likely to be the result of other harmless processes rather than ALCL. Most of the cases reported to date have been in women undergoing implant revision operations for late onset, persistent seroma.
Does the type of breast implant increase the risk of ALCL?
There have been some suggestions that textured breast implants may be associated with ALCL but the truth remains that there are no studies available to show whether ALCL may be found more or less frequently in women with textured, smooth, saline or silicone implants.
What is the advice of the regulatory authorities?
Due to the exceedingly rare nature of ALCL and the difficulty in proving any causal relationship with breast implants, there have been no recommendations to withdraw breast implants. Breast implants remain safe for use in cosmetic augmentation and breast reconstruction. Detailed information from the US FDA can be followed under the links below.