Breast Implant ALCL Rates in U.S. Reported By New National Registry

A new national registry designed to track instances of anaplastic large cell lymphoma (ALCL) from breast implants has identified at least 148 different cases in the United States since 2011, as part of an effort to better evaluate the cancer risks women may face from certain types of implants.

The American Society of Plastic Surgeons and Plastic Surgery Foundation, in collaboration with the FDA, have developed a national registry, known as the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE) registry, and released the first findings at a meeting earlier this month in Orlando, Florida.

The registry is the first of its kind in the U.S., and arose amid growing concerns over about reports of the rare blood cancer that has come to be known as breast implant-associated anaplastic large cell lymphoma (BI-ALCL), since it has been associated with the use of certain types of implants.

From data collected between October 2011 and June 2017, researchers found at least 148 “distinct, pathologically confirmed” breast implant ALCL cases in the United States. It has received complete case forms on 77 of those cases, or 52%.

From the more detailed reports filed, PROFILE researchers found that 53% of the cases involved women who had cosmetic breast augmentation, while 43% of cases occurred in women who had post-mastectomy reconstruction. The mean time from implantation to diagnosis was 11 years. They also found that 43% of cases involved saline implants, while 51% involved silicone.

The abstract released for the conference did not mention what percentage of the breast implants involved textured surfaces, a feature that has been closely linked to BI-ALCL in other cases.

Earlier this year, the FDA issued warnings about breast implant lymphoma rates, indicating that the agency was aware of at least 359 medical device reports worldwide involving women diagnosed with the rare form of non-Hodgkins lymphoma, including at least nine deaths.

After Australia’s Therapeutic Goods Administration (TGA) launched an effort to monitor for cases of anaplastic large cell lymphoma (ALCL) from breast implants, the number of identified cases in that country more than doubled, increasing the level of concern among doctors and patients worldwide.

There is little known about the cause of the breast implant cancer, but investigators have noted that the risk seems higher among women with breast implants that have a textured surface, which may be causing chronic inflammation and immune system reactions, leading to the development of lymphoma in the fluid around the breast implant.

In June, another study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.

As researchers continue to evaluate the specific cause of the breast implant lymphoma problems, many women are raising serious questions about why certain products appear to be more likely to be associated with the development of cancer, and how manufacturers failed to address potential design defects earlier.

Product liability lawyers are reviewing potential breast implant ALCL lawsuits for women diagnosed with this rare cancer that develops in the tissue surrounding the implant.