Nearly 1 month after the hearing on the safety of breast implants, the Food and Drug Administration stated on Thursday that it might not prohibit textured breast implants that have been associated with a form of lymphoma.
Textured implants by Allergan have already been removed the market due to safety concerns in nearly 40 nations, including Canada and France. But the FDA announced that there is not sufficient evidence to issue a ban in the US.
“At the time being, we don’t believe that, based on the available information and reports. The product doesn’t meet our banning standards,” the agency announced.
The implants, which feature a sandpaper-like, rough texture, are associated with a type of cancer in the immune system. If not treated early, it would be fatal. More than 350 women in the US have been diagnosed with this condition, while 15 people have died of this disease all over the world.
“This issue is still ignored and there are more women diagnosed and died of this disease,” said Michael Sandel, an expert on the condition. “Nevertheless, not prohibiting textured implants just because it does not meet banning standards from a legislative act makes me worried about how this country can protect our kids and us from other cancer-causing products.”
The FDA declares that it is trying to contact manufacturers and patients to make label changes and include a black box warning, which is the strictest caution of the FDA. Also, manufacturers would be required to file adverse effect reviews rather than the existing practice, and all of the information will be available to the general public.
“We are planning these measures to make sure that every woman who chooses breast implants is informed with the necessary info to make a balanced and comprehensive decision about the risks and benefits of these devices,” said the FDA.
But many experts concern that the actions are not enough to protect women.
“It is necessary to make data available to consumers and researchers, but perhaps it won’t be helpful for most doctors and patients,” another expert said.
The agency first found out a possible connection between breast implants and the disease in 2011. While it is still unclear about the commonness of the condition, it is estimated that the rate ranges from 1/3000 to 1/30,000 woman. However, recent reports have found that it can be an emerging risk with the rate of developing as high as 1/1,000 people.