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 of affected patients.”
Today, the FDA sent warning letters to two breast implant manufacturers citing “serious deficiencies” in the companies’ long-term studies to evaluate the safety and risks of their products—studies that were required as part of the approval process for the implants.
“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” said FDA Commissioner Scott Gottlieb. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety.”
More than 300,000 women got breast implants for cosmetic reasons last year, 4 percent more than the year prior. Breast-implant removals were up 6 percent, to 29,236.
All surgeries carry risk. So it’s no surprise that sticking a squishy bag under the breasts has its fair share. Both saline and silicone breast implants are approved by the FDA, but the agency had long offered several cautions.
For one, they usually have to come out at some point.
“Breast implants are not considered lifetime devices,” the agency cautions. “The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery… while a few people may keep their original implants for 20 to 30 years, that is not the common experience.”
Other risks long noted by the FDA:
- Breast pain
- Changes in nipple sensation
- Wrinkling, displacement or asymmetry
And here’s a doozie: Rupture, detailed thusly by the FDA: “Leakage of the saltwater (saline) solution from a saline-filled breast implant, often due to a valve leak or a tear or cut in the implant shell (rupture), with partial or complete collapse of the implant.”
Some 20 percent of breast implants require removal within 10 years, the agency says. If they’re not replaced, well: “Women who do not have their implants replaced may have cosmetically undesirable dimpling, puckering, or sagging of the natural breast following implant removal.”
A study published in the Annals of Surgery last year looked at data on 100,000 breast-implant patients, finding an association with certain cancers and autoimmune diseases.
Arthritis, Melanoma, Scleroderma?
Patients who received one brand of silicone implants reported between two and eight times higher rates of rheumatoid arthritis, melanoma, scleroderma (hardening of the skin) and Sjogren syndrome (which causes dry mouth and dry eyes), compared to the population at large. Those with another brand of silicone implants reported twice the normal rate of dermatomyositis (skin rash and muscle weakness), scleroderma and Sjogren syndrome.
“All surgical procedures and implantable devices have potential complications and side effects,” said study leader Mark Clemens, a professor in plastic surgery at the University of Texas MD Anderson Cancer Center. “This is important safety information for women to consider when thinking about cosmetic or reconstructive surgery with breast implants.”
But Clemens stressed that the study showed associations, not cause-and-effect, adding that more research is needed.
Note: Some of background material in this article was previously published in this one: Boob Jobs, Butt Lifts & Botox Grow Despite Real Risks.