FDA Pushing For Stronger Warnings About Dangers Of Getting Breast Implants
PHILADELPHIA (CBS) -- The FDA wants women considering getting breast implants to receive stronger warnings about dangers. The agency announced Wednesday recommendations that would require manufacturers to include black box warnings with breast implants.
Most women who get breast implants are fine but they do face an increased risk for a variety of problems, including rupture, pain, chronic fatigue and even a rare cancer.
The FDA says women need to be better warned about those potential complications.
"I think the FDA is finally taking a better stance on the complications and problems occurring with implants," Dr. Kirk Brandow said.
Brandow, a Bala Cynwyd plastic surgeon, is applauding the FDA's proposal to better warn women about potential problems linked to breast implants.
In calling for black box warnings, the strongest available, the FDA wants women to know.
Implants have an increased risk of causing a rare lymphoma. Also, they are not lifetime devices and complications increase the longer they're in place.
"The largest number of cases are with the textured ones," Brandow said.
Textured implants reduce the risk for hardening but they also increase the risk for serious complications. The FDA has received thousands of complaints about breast implant-associated illnesses.
And while breast augmentation remains the most popular type of cosmetic surgery, with 400,000 women getting them yearly, there are also a growing number of women having them removed.
"In the past three months, I've removed eight implants, and the trend is for a lot of patients coming in saying, 'I really don't need these implants anymore. I want to take them out,'" Brandow said.
While both saline and silicone implants are approved, Brandow only uses saline, which he says is much safer.
Wednesday's announcement from the FDA is a recommendation. There will be 60 days for public comment before a final guidance is issued.
Breast implants are only supposed to last up to 10 years, then doctors say they should be removed or replaced.
Some surgeons, like Brandow, are using the patient's own fat, instead of an implant, to enhance the breast.