Member-only story
FDA Questions Safety of Breast Implants
New concerns raised about health risks, plus warnings to manufacturers for failing to study those risks.
The U.S. Food and Drug Administration raised the alarm level on breast implants in two separate actions in recent days.
On March 15, the agency said in a statement that more cases had been confirmed of anaplastic large cell lymphoma linked to breast implants. The disease is a type of non-Hodgkin’s lymphoma that usually stays around the scar tissue but “can spread throughout the body.”
The FDA has in the past warned of health risks related to breast implants (see below). But in the new statement, it acknowledged a slew of other possible health problems that may be linked to breast implants and called for further study:
“We’ve also heard from patients who are concerned that their implants may be connected to other health conditions that could be associated with their immune system’s response to these devices, resulting in symptoms like chronic fatigue, cognitive issues and muscle pain,” the agency said. “While the FDA doesn’t have definitive evidence suggesting breast implants are associated with these conditions, we’re looking to gain a fuller understanding of this issue to communicate risk, minimize harm and help in the treatment…