What the FDA Says About Cancer Risk and Breast Augmentation
Recently there has been a lot of attention directed at a recent FDA notice regarding cancer risk and breast augmentation.All of this attention is not directed at your typical common breast cancer that most women dread. It is directed at another type of cancer that is extremely rare, called ALCL (Anaplastic Large Cell Lymphoma), which is really not a breast cancer but a type of lymphoma.
Let me first alleviate your fears about breast augmentations using silicone or saline implants regarding common breast cancer. Breast cancer primarily deals with the glands of the breasts, i.e. the parts of the breasts whose function is to make and secret breast milk after a pregnancy. There is no evidence to suggest that breast implants increase your risk of developing breast cancer.
However, the FDA has recently stated that they want further information of the long-term effects of breast implants and this other cancer which appears to be associated with breast implants. ALCL is a type of lymphoma, i.e. has to do with the lymph system, which grows in the scar tissue surrounding the breast. It does not deal with the actual breast tissue as in the commonly understood forms of breast cancer. The FDA is always on the lookout for possible complications of any device or drug, including the use of implants.
The incidence of ALCL is around one case in 30,000 patients who have had implants, but this varies from different analysis, with some reports stating a one in 3,817 incidences. Almost all these implants used are called “textured” implants.This type of implant has a roughened surface and is used mostly in Europe, while most American surgeons use the “smooth” type of implant. There are very very few cases of ALCL associated with smooth implants.
There is not a difference in whether the silicone implant or the saline implant was used. In the data evaluated by the FDA, almost half had saline and the other half had silicone. It really depended more on whether the implant was textured on the shell, or outside covering of the implant versus the substance the filling the implant.
ALCL is a very slow growing cancer and most cases are very treatable.Worldwide there have only been twelve deaths linked to the disease compared to the millions of patients who have received implants.
According to Dr. Mark Clemens at the MD Anderson Cancer center, “We recognized 152 unique and confirmed cases in the U.S., and the shortest time interval to development has been 2.2 years after implant.”
The most common symptom is delayed seroma, which is a fluid collection around the implants within a scarred capsule. There is no currently available testing for the test unless a seroma is present. If such fluid is present, a special genetic typing of the cells within the seroma fluid can be determined which correlates with ALCL.Breast Implant–Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk.
Basically, the FDA statements concern the need for further evaluation and patient registry of the cases of ALCL.They want to evaluate this risk further and define the long-term risks of patients with implants with respect to development of ALCL.
What this means for women with implants is this. First, if you had smooth implants placed, don’t worry about ALCL. The risk of you developing this lymphoma is extremely rare. If you had textured implants, the risk is still very rare. However, if you develop a seroma months to years after textured implant surgery, make sure the fluid is taken to detect the maker that may implicate the possibility of ALCL. For 99% of Americans who have had breast augmentation, be happy and don’t worry; the chance of you getting ALCL is very small.
At our office of DrTrue / TrueMD, we have consistently stated in our consent sheets that there is a possible growth of ALCL, but the incidence is extremely low. Moreover, 99% of the time we use smooth implants, and only use textured in that rare situation when specifically requested by the patient. We have never seen a case of ALCL and, most likely never will considering the rare incidence of this cancer. But if we did, we would submit the information to the FDAfor their Registry.
Lock-Wilkinson A, et al. Plastic and Reconstructive Surgery. 140(4):645–654, OCT 2017. DOI:10.1097/PRS.0000000000003654
Clemens, M. HIA-ALCL Resources. American Society of Plastic Surgeons. February 8, 2019