23 March, 2017
The FDA has received more than 350 reports, including the nine deaths, as of February 1, about breast implant-linked anaplastic large cell lymphoma, ALCL, an extremely rare cancer that affects the immune system.
The FDA said that the condition occurs most frequently in patients undergoing implant revision operations for late onset, persistent seroma.
The FDA notes that it is unclear how many cases of implant-related cancer exist due to a lack of data and reporting problems. About 28 implants were smooth while 203 other were textured. Breast implants approved in the US can be filled with either saline or silicone gel and come in different sizes and shapes and have either smooth or textured shells.
Most cases have been treated by removing the implant but some women have required chemotherapy and radiation, it said.
Health risks associated with either type of implant include capsular contraction (scar tissue distorting the implant's shape), breast pain, infection, implant leakage or rupture, and changes in nipple or breast sensation.
"There's many kinds of texturing, and different companies do it differently", Srinivasa says, so it's hard to know what specific quality of textured implants could be associated with the cancer.More news: EBay to launch Guaranteed Delivery in U.S. this summer
The cancer is not breast cancer, the FDA emphasized.
"The release advises women to educate yourself about breast implants before agreeing to surgery". Last year, the World Health Organization classified breast implant-associated ALCL as a separate diagnosis, and authorities in Australia and France took steps to track and assess the connection. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant.
"Follow your doctor's instructions on how to monitor your breast implants".
Exactly how breast implants might cause cancer is not known.
The FDA said that people who are considering getting breast implants should talk with their doctors about the benefits and risks of textured implants versus smooth implants. So far, scientists haven't found a link between the lymphoma and the material used to make the implant-saline and silicone implants appear to be equally affected.
Safety concerns are a high priority when opting for breast augmentation procedures, as both types of breast implants - saline and silicone - pose a series of health risks.