There’s no understating the disappointment felt by manufacturers of silicone gel breast implants, plastic surgeons–and, of course, many women–when the federal government voted in January to continue a 12-year-old ban on the implants.
But manufacturers have a card up their sleeve, and they plan to play it soon.
Three companies are working on a different type of silicone gel breast implant, called a cohesive gel implant, which they say is unlikely to leak or rupture. One manufacturer, Inamed, plans to file paperwork later this year seeking approval to market the product.
Although still made of silicone, the gel in the new implants has the consistency of gummy bear candy; the gel inside traditional implants has a motor-oil feel.
Even in the event the new implants do rupture, researchers say, the silicone won’t leak and migrate to other areas of the body. In its January ruling, the Food and Drug Administration had cited concerns over what happens when silicone implants rupture and this migration occurs.
“These cohesive gel implants make a lot of the questions the FDA asked irrelevant,” said Dr. William P. Adams Jr., associate professor of plastic surgery at the University of Texas Southwestern Medical Center in Dallas. He is researching a cohesive gel implant made by Mentor, which may be ready to seek approval for its product by the end of next year.
“There is good data on cohesive gel implants in the United States and Europe, and everyone’s hope is that these implants can be approved,” Adams said.
Cohesive gel implants also are superior to other types of implants in terms of cosmetic results, some plastic surgeons say.
“Patients are dissatisfied with saline implants,” said Dr. Grant Stevens, medical director of Marina Plastic Surgery Associates in Los Angeles. “They don’t like the ripples or the liquid feel. But they, and the FDA, have some concerns about liquid silicone.”
The cohesive gel has a better feel and look but eliminates the question of what happens when liquid silicone migrates out of the breast, added Grant, a clinical investigator on a cohesive gel implant made by a Dallas-based company called Silimed.
The first breast implants containing silicone gel were introduced in the U.S. in 1963, but they were banned in 1992 except for use in clinical trials and by women undergoing breast reconstruction surgery.
Some studies suggested that the implants caused autoimmune diseases, such as lupus and arthritis, but a 1999 report from the Institute of Medicine found no link between the implants and those diseases.
In January, however, the FDA decided to continue the ban, saying that manufacturers had not answered questions about why implants rupture and where the gel goes when implants leak.
One criticism of the cohesive gel implants is that they may prove to be too rigid for some women. Also, because the implants are less flexible, surgeons may need to make a slightly larger incision to place the implants into the breast, Adams said.
Even leakage of the silicone from a cohesive gel implant, while unlikely, cannot be ruled out based on studies so far, Adams added.
The lack of long-term data is what concerns some consumer activists.
“Without long-term studies, we won’t know whether this cohesive gel is any better than what has been presented before,” said Sybil Niden Goldrich, executive director of the Command Trust Network, a consumer group that has criticized the safety of implants.
Breast boom
American women can still obtain saline implants (and silicone gel implants under the FDA restrictions)–and they appear to be doing so in record numbers. More than 254,000 women underwent breast augmentation in 2003, a 20 percent increase from 2000, according to the American Society of Plastic Surgeons.
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Edited by Cara DiPasquale (cdipasquale@tribune.com) and Kris Karnopp (kkarnopp@tribune.com)
