Many women hoping for a more natural-looking alternative to saline breast implants were disappointed by the Food and Drug Administration’s recent decision to maintain the ban on silicone-gel-filled implants. But there may be other options on the market one day, as doctors continue their quest to find better ways to boost a woman’s bosom.
Among the most promising developments, they say, are cohesive silicone gel, leak-resistant implants with the consistency of a gummy bear and a new type of implant shell coating that may be less likely to cause inflammation and scarring in the surrounding breast tissue.
“I think we are getting closer to developing the perfect implant, in terms of durability, biocompatibility and natural shape,” says Dr. Mark Jewell, a plastic surgeon and vice president of the American Society for Aesthetic Plastic Surgery.
Safety concerns linking ruptures of the silicone gel implants to autoimmune problems in some women caused the FDA to ban the sale of the implants in 1992, except for use in clinical trials and by women undergoing breast reconstruction. While the implants were somewhat exonerated by an Institute of Medicine report saying they do not up the risk of autoimmune disease, the new FDA ban calls for more study before they can be put back on the market.
Both saline- and silicone-filled implants have a silicone shell. But if the saline implants leak, deflate or rupture, which they often do, they would release only salt water — not silicone — into the body. The downside of the saline implants, though, is that they don’t look and feel as natural as the others.
“Some people are concerned about the safety of silicone gel and many people are disappointed about the performance of saline implants, notably that they are associated with more ripples, have a more liquid feel and don’t look as natural as the silicone implants,” says Dr. Grant Stevens, medical director.
‘Gummies’
Enter cohesive gel implants, which are currently on the market in other countries, and now being studied in the United States.
“The ‘gummy bear’ implants have the positive attributes of the silicone gel, but lack the concerns of gel migration,” says Stevens, who is one of 15 U.S. doctors participating in a study of Silimed cohesive gel implants.
Dr. William P. Adams, Jr., agrees. “The gel doesn’t migrate, so there are potential safety benefits because if the shell should fail, the gel will not go anywhere — it would just stay in one place,” says Adams, an associate professor of plastic surgery at the Southwestern Medical Center.
And unlike saline implants, Stevens notes, “cohesive gel implants feel like breast tissue, not a water balloon.”
So far, he adds, the data and patient response are “overwhelmingly positive.”
Last October, 42-year-old Charlie Sheridan, who works in Stevens’ office, traded in her saline implants for a pair of cohesive gel implants as part of the clinical trial.
“I am sporting a pair of gummies,” Sheridan says. “They have the look and feel of silicone, but don’t have the hardness or lack of naturalness of saline and there is no worry of deflation,” she says. One of her saline implants did, in fact, deflate which is why she opted for the newer model.
The companies that manufacture breast implants also are conducting studies of their versions of the cohesive gel implants.
Experts in the field say it could be at least three to five years before any such product is on the U.S. market, provided the FDA approves one.
But not all plastic surgeons are<