The Food and Drug Administration identified a relationship between breast implants and anaplastic large cell lymphoma (ALCL) in 2011. This relationship seems to have been confirmed.
As of February 1st, the FDA has received 359 reports of this rare form of cancer that is associated with breast implants. Despite being directly associated with breast implants, the cancers were not the cause of death in the nine patients. Anaplastic large-cell lymphoma, a rare malignancy in the immune system, was ultimately responsible for the casualties.
Amongst all reported cases of cancers associated with breast implants, those who used textured implants were found to contract cancer more often than those who used smooth implants.
The FDA reports, “As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants.”
The contents of the implant are not associated with an increased likelihood of ALCL diagnosis. Both silicone gel and saline filled implants had comparable representation in the 312 cases of ALCL in which the implant contents were known.
Symptoms of breast cancer associated with implants include lumps, pain, fluid buildup, and swelling.
It is difficult for the FDA to pinpoint exactly how many cases of cancer associated with breast implants exist because of limited data on the sale of implants worldwide. However, it is known that approximately 290,000 women in the United States received breast implants, and approximately 109,000 received them after undergoing reconstructive breast surgery after battling with breast cancer.
According to the FDA, these numbers are likely below the actual values of people who received breast implants. The FDA reports that “The incidence or prevalence of an event cannot be determined from the MDR reporting system due to potential under-reporting, duplicate reporting of events, and the lack of information about the total number of breast implants.”
Researchers are still unsure of exactly why there is a discrepancy between smooth implants and textured implants. Studies conducted on rats have shown an increase in activity in tissues that have been exposed to textured implants as opposed to smooth ones.
Dr. Alex K. Wong, a plastic surgeon and researcher at the Keck School of Medicine at the University of Southern California, says, “When we take these out, you can hear a peeling sound, whereas a smooth implant is like Jell-O. You can spin it around. It moves really easily.”
Textured implants are generally used by doctors seeking to fit a specific anatomical form. If these implants shifted or rotated like smooth implants, they would look unsightly and not provide the natural look desired.
Despite these concerns regarding cancer associated with breast implants, the FDA has actually asked doctors with patients without symptoms to not remove implants. The FDA states that “[ALCL] has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.”
The study does not defame breast implants, but serves to act as a warning to carefully monitor and examine patients that have received implants. BIA-ALCL is a very rare condition but it has shown to manifest more commonly in women that have received textured implants.
The FDA stresses that, regardless of type of implant, women should continue to receive standard check-ups and stay aware of the warning signs, lumps, pain, fluid buildup, and swelling, that may indicate complications. The FDA recommends that any patients who notice change should contact their healthcare provider to schedule an appointment and have routine mammography screenings with a technologist specifically trained with patients with implants.
Studies regarding these findings are still ongoing, and as more data is added and analyzed, researchers hope to attain a better understanding of the condition. The FDA urges health care providers to report all confirmed cases of ALCL associated with breast implants so that they can ask for additional information and help other women who are at risk.
Sources: Grady, D. (2017, March 21). 9 Deaths Are Linked to Rare Cancer From Breast Implants. Retrieved March 21, 2017.
Breast Implants - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).