JACKSONVILLE, Fla. — Dee Hicks couldn’t wait to get breast implants. She was after that confidence boost many women want so badly.
The implants were life-changing. ”They were great until they were not,” Hicks recalled.
Hicks now works at a surgeon’s office where patients get their implants removed. ”They look beautiful on the outside, but on the inside, they’re wreaking havoc,” she said.
Hicks says her body formed scar tissue around her implants, causing immune dysfunction. Chest rashes, sinus infections -- you name it. Hicks says she was sick all the time. Once her implants were removed, she felt better immediately. That led her and a group of women to push the FDA to enforce more warnings.
Her efforts are now paying off. ”This is such a huge step in the right direction,” Hicks said. Now, the FDA is strengthening its safety rules when it comes to warning patients about breast implants.
Manufacturers are now required to include a boxed warning explaining the risks, which include infection, rupture, and in rare cases, lymphoma. Doctors must improve the patient’s informed consent process, and check for implant ruptures in their patients later on.
”Breast implant surgery is probably the most common cosmetic procedure performed in the United States,” Dr. Erez Sternberg said. He’s among five plastic surgeons at Ponte Vedra Plastic Surgery. Together, they perform around 1,500 implant procedures a year.
”You have to know the risk going in,” Sternberg said. “90% plus patients have no problems with implants and do very well with them in the long term. There are certain subsets of patients that don’t do as well. They either get hardening of the implant (capsular contracture), they can get an infection around the implant, they can reject the implant in some scenarios. So I think having that real good dialogue with the patient letting them know ‘yes they are great implants, they are a great device and well-studied, overall they are safe.’ Like everything else there is a pro and a con, and helping the patient really understand these issues through an informed consent process is really good and that’s what the FDA trying to do.”
Sternberg says doctors still don’t know why some patients have implant illness syndrome like Hicks did, and it can take around seven years for a patient to find out if their body is rejecting an implant.
”It’s certainly a great procedure and we don’t want to scare anyone away, it’s very effective and patients are very happy, but the more you know going into a surgical procedure, the better,” Sternberg added.
Both Sternberg and Hicks say the FDA took a step in the right direction.
”It’s going to make a difference,” Hicks said.
The FDA expects implant manufacturers to update the labeling of their implants on their websites by the end of the month.
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