NEW ORLEANS -- Getting breast implants continues to be the number one cosmetic surgical procedure in the United States, and now there is something new for women that some believe is not only safer, but more natural looking as well.
In 2009 Medical Watch took a first look at something new for U.S. women, the latest breast implants nicknamed "gummy bears." Women in countries all over the world had been using them for nearly 20 years. In the U.S., they were being tested.
Back in 2009 we talked to Metairie plastic surgeon Dr. Gustavo Colon and asked if women who used the implants liked them.
"I haven't heard from women. I've heard from doctors, and they say they like them. They get very good results," said Dr. Colon.
Now they are approved for use in the United States. Three companies will manufacture the new gummy bear implants but right now only Sientra has FDA approval. Five year follow up studies show its product is effective and safe.
"They cannot deflate. That's the beauty of this implant is that you have a shaped implant that actually maintains the way it looks. Even if you cut this implant, it's still going to maintain its shape," explained Dr. Kaveh Alizadeh, president of the Long Island Plastic Surical Group.
Doctors got a first look at the new implants in New Orleans at the largest gathering of plastic surgeons in the world. Dr. Alizadeh came to the late October meeting of the American Society of Plastic Surgeons.
"These are all an improvement over what we had as recently as a couple of years ago," he said.
He says women have more choices now. There's the old, round shape and different styles of a tear drop, a more anatomically shaped implant that looks and feels more like a natural breast. Because they are "gummy bear," or a semi-solid, high strength, cohesive gel, the shape stays stable over time. They last longer because there are fewer complications, including the risk of getting the painful scaring and hardening called capsular contracture. And experience from other countries shows they are less likely to rupture, because the natural shape keeps them from making folds or creases that you can feel through the skin.
"So it's no longer one size fits all. The round implant we're trying to make it fit everyone. So there is a lot of options available, and I think the patients need to be educated and needs to come and ask their doctor specifically about, 'Is this available for me. And, 'Is it a good option for me,'" said Dr. Alizadeh, who has been a principal investigator on clinical trials.
"Knowing that that implant is form stable, it's not liquid, the risk of rupture disappears, and so they don't have to worry about that," said the immediate past president of the American Society of Plastic Surgeons, Dr. Malcolm Z. Roth of New York and Albany.
With this implant doctors feel it is best to put under the muscle, going in through a one to two inch incision in the fold under the breast. And good news for cancer patients: doctors say they work well for women who need reconstruction after a mastectomy.
Bottom line, the doctor and patient should talk about what custom design is best for her body.
The correct term for these implants is "form stable." Doctors recommend you go to a board certified plastic surgeon, who has experience, because you don't want the implant pocket too loose where this implant could rotate since there is a top and bottom to it.
Four brands were studied in the U.S.: Allergan's 410, Mentor's CPG, and Silimed/Sientra's Nuance and Enhance. It is unclear when the others will get FDA approval.
Dr. Kaveh Alizadeh authored the "Five-Year Follow-Up data from the U.S. Clinical Trial for Sientra's U.S. Food and Drug Administration-Approved Silimed Brand Round and Shaped Implants with High-Strength Silicone Gel."