The U.S. Food & Drug Administration (FDA) has issued a new warning regarding breast implants and a rare type of cancer called anaplastic large cell lymphoma (ALCL). According to an alert issued yesterday, silicone and saline breast implants have been implicated in nine cancer deaths and at least 350 reports in which the devices may be associated with onset of the disease.
“All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants,” the FDA said in its statement.
The available data now suggests that ALCL is more likely to occur among women who receive textured breast implants.
“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 FDA noted.
Of the reports indicating implant fill type, 186 involved silicone gel devices and 126 reported implants filled with saline.
The FDA first warned of a possible link between ALCL and breast implants in 2011. However, so few cases had been reported that it was impossible to identify what factors might increase a patient’s risk for the disease. Since then, however, more information has been collected that points to breast implants as a cause of ALCL.
It’s important to note that ALCL is not breast cancer. However, the existing medical literature indicates that most cases of breast implant-associated ALCL occur in the area around the implant. The main symptoms noted incuded swelling or pain in the vicinity of the device. Symptoms of the disease may present well after the surgical incision has healed, even years after implant placement.
According to the FDA, there is no need for women with breast implants to alter their routine medical care and follow-up.
“Follow your doctor’s instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment,” the agency advised. “Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants.”
This is not the first time breast implants have been linked to serious side effects. In fact, thousands of women filed suit against device manufacturers in the 1980s and 1990s, claiming that silicone breast implants had caused autoimmune disease and other health problems. Billions of dollars were ultimately spent to settle those cases, and the FDA imposed a near ban on silicone devices for 14 years starting in 1992.
Restrictions on silicone breast implants were lifted in 2006, and now three companies — Allergan Plc, and Sientra Inc. and Mentor Worldwide – are licensed to market the devices. However, researchers continue to study the long-term health impacts of both saline and silicone implants.
According to a report published by Bloomberg News earlier this year, at least two new breast implant lawsuits have been filed on behalf of women who claim that Mentor’s MemoryGel silicone implants made them ill. An attorney for one of the women asserted that the filings could be just the “tip of the iceberg,” and claimed that Mentor’s silicone breast implants may have caused illness in thousands of women.