Breast implants are changing


Breast Implants Undergo Reconstruction
By ABBY ELLINDEC. 2, 2015  New York Times  December 2, 2014   –   PHOTS OF IMPLANT
Dr. Robert S. Hamas created the Ideal Implant, which bills itself as “natural feel without silicone gel.” Credit Rex C. Curry for The New York Times

Hilary Miller’s breasts are not what they once were. Two children and many feedings later, they simply don’t have the perkiness of youth. “I’d like them to look the way they used to,” said Ms. Miller, who works at a beauty company in Dallas.

She has long wanted an augmentation, but she worried about silicone implants. Never mind that the Food and Drug Administration approved them in 2006, after they were removed from the market in 1992 while the F.D.A. evaluated their safety. After years of litigation and expert panel study, silicone gels were deemed safe, but the stigma has remained. Many women still fear “silent ruptures,” that is, tears that are undetectable without an M.R.I., which can cost thousands of dollars and usually isn’t covered by insurance. Many women also fear foreign substances coursing through their veins, worrying that they cause autoimmune diseases or cancer.

“I don’t like the idea of something in my body that I don’t know about,” Ms. Miller, 38, said. Saline didn’t appeal to her; she didn’t want to feel as if two water balloons were dwelling beneath her blouse.

So in September, Ms. Miller got something called the Ideal Implant, which bills itself as “natural feel without silicone gel.” The implants, created by a Dallas plastic surgeon, Dr. Robert S. Hamas (pronounced HEY-mus), are made of saline. But instead of bouncing around and potentially scalloping or folding, as saline implants tend to, they are as soft as gel.

“They look good; they feel natural,” said Ms. Miller, who paid about $7,000 for the implants and a breast lift. “I like the way they fit in my clothes. I’m very happy.”

A 2014 analysis in the Archives of Plastic Surgery found that silent ruptures occurred in 9 to 12 percent of cases eight years after implantation. The F.D.A. advises women with silicone-gel implants to get an M.R.I. three years after the original surgery, and then every other year thereafter. Unlike silicone, saline implants deflate if there’s a leak, so it’s easy to tell if there’s a problem.

Dr. Hamas has been working on his product since 1992, shortly after the moratorium on silicone. The idea was to figure out a way to keep the saline from sloshing around like a whiskey sour. After much trial and error, he created a series of implant shells nested together, like Russian dolls, and two separate chambers that hold saline. This internal structure limited the saline’s ability to move, while supporting the implant edges to reduce wrinkling.

The company, Ideal Implant Inc., which he started in 2006, is majority owned by about 120 board-certified or board-eligible plastic surgeons, and gained F.D.A. approval in 2014. It was made available to the public in September of this year. Sort of.

The Ideal Implant, which costs $1,500 a pair in addition to surgical costs, slightly higher than silicone implants, is only available to the shareholders and 45 doctors who investigated them for the F.D.A. (none of whom have a financial stake in the company). But demand far outweighs supply, so doctors have been compiling waiting lists of women who want them.

“Ten years ago, when Dr. Hamas showed it to me, I thought it was a good idea to improve upon saline implants, especially back then when that was all we had,” said Dr. James. C. Grotting, a plastic surgeon in Birmingham, Ala. “I didn’t know it was going to take so long.”

Dr. Kevin Brenner, a plastic surgeon in Beverly Hills, Calif., who was one of the original F.D.A. investigators, said he has patients who have been waiting five years. “Breast augmentation is a very personal decision for most women, and they’ve got to be comfortable with what I’m putting in them,” he said. “Both saline and silicone have upsides and downsides. The Ideal Implant is the best of both worlds.”

A diagram showing how the implant has been built with baffles.
Not every doctor is on board. Dr. Scot Glasberg, a plastic surgeon in New York and the immediate past president of the American Society of Plastic Surgeons, said he has received calls from a half-dozen doctors concerned about the marketing of the Ideal Implant. “It suggests in a roundabout way that silicone is not safe,” he said. “We’ve spent such a large amount of time ensuring the safety of silicone products. We’d hate to have a situation where anyone, even in a remote way, is trying to lay a foundation that they’re not safe.”

Dr. Steven Teitelbaum, a plastic surgeon in Santa Monica and president of the California Society of Plastic Surgeons, doesn’t even see the need for another saline implant. According to the American Society for Aesthetic Plastic Surgery, in 2014, 20 percent of breast augmentations involved saline. “Nobody comes in asking for saline except real bargain hunters or women who want really enormous implants but small incisions,” Dr. Teitelbaum said. (Saline implants can be inserted around the nipple or through a cut in the underarm, and then inflated.) “A saline implant can never feel like a silicone implant.”

He also worries about the data, or lack thereof. F.D.A. approval was based on the initial results of a two-year study, published in the September 2012 issue of the Aesthetic Surgery Journal. Dr. Hamas is one of the authors. A 10-year study of nearly 500 women ages 18 to 67, also conducted by the company, is underway. It will conclude in 2019.

And finally, Dr. Teitelbaum is bothered by the implant’s limited availability. “You don’t launch a product when you don’t have it ready to ship,” he said. “It’s a false launch.”

Dr. Hamas stresses that his company is tiny, which accounts for its inability to produce mass quantities of the implant. It wouldn’t have been able to get off the ground without investments from other doctors. And he believes women are worried.

Breast implants are changing.

“A lot of plastic surgeons say, ‘Don’t worry about silicone, the F.D.A. has approved it,’” he said. “The F.D.A. has said silicone gel is safe but women should get an M.R.I. scan every other year, for life, to see if they’re ruptured because you can’t tell by examining a patient or looking at it.”

Dr. Grotting and other investors say they aren’t going to get rich from the Ideal. They are happy to disclose their financial interest to patients. “I show women all the devices available, and explain the pros and cons of each,” he said. (Informing patients of financial interest in a product is determined on a state-by-state basis by state medical boards.)

Dina Kaufman, a 29-year-old graphic designer in Hoboken, N.J., is on the waiting list with Dr. Sherrell Aston, a plastic surgeon in New York and an investor. Over the last six years, Ms. Kaufman has lost about 100 pounds, and wants a breast lift and implants to help bring back the shape of her breasts from before she lost the weight.

“The saline wasn’t as natural and you could tell they were fake, and with silicone I read a lot of horror stories,” she said. “Because I’m so young, I didn’t want to have to worry about them.”

She read an article about the Ideal Implants a few years ago. That her doctor is a minor investor in the company doesn’t bother her at all. “It makes me want it even more,” she said.