Cohesive Gel: Can Silicone Implants Be Safe?

Over the past year Dr. Donald Kress, a practicing plastic surgeon in Washington, D.C., has performed breast augmentations on about 160 women using a silicone implant. Now I know what you're thinking, "weren't silicone implants banned in the U.S. years ago because they were too dangerous?" Actually, the implant that Dr. Kress uses is called a cohesive gel implant or "gummy bear" implant, manufactured by Rio de Janeiro based Silimed, a new type of implant that is currently under FDA trial in America.

Silicone Vs. Saline: The U.S. Breast Debate

The history of silicone implants in the United States is a highly publicized one, full of debates about effectiveness and health risk. In 1992 the FDA placed a moratorium on silicone implants in the U.S., meaning that the most popular type of implant would no longer be available to patients seeking cosmetic enhancement. The moratorium was placed on silicone implants due in large part to concerns of health risks in the event that the implant ruptures. Since then, silicone implants have been available only for re-operations and major reconstruction, with only saline implants available for cosmetic purposes.

The biggest problems with saline implants are that they wrinkle and fold with greater ease than silicone, some women complain that they do not feel natural, and, according to Dr. Kress, some saline manufacturers report re-operation rates that are as high as 40%. With the cohesive gel implant, what Silimed is calling their "high strength" implant, these problems are nearly eliminated. In Europe, this type of implant has been used for years, and the use of its saline counterpart is almost non-existent. In fact, says Dr. Kress, "the whole world laughs at us. 'The Americans and their sacks of water' they say." But with the stigma that has attached itself to any concept of a silicone implant in this country, it is difficult to reverse tradition, even when clinical information points to a safer and better alternative.

What Is Cohesive Gel?

Dr. Donald W. Kress

The new cohesive gel implant is safer, says Dr. Kress, because with the amount of cross-linking of the silicone strands the gel is so thick that even when cut, liquid and oil do not leak out, leaving the implant in its original shape. In fact, Dr. Kress has an implant that he sliced and placed on a paper towel in his office about a year ago. In that time there has been not even a drop of oil that has leaked, and, he points out, there have even been German studies that suggest that the environment necessary to cause leakage would not even be possible to create in a living human.

This news aside, however, there are instances when this type of implant may not be the best option. Anything larger than D cup would require too big of an implant and would not look natural. Additionally, for patients who are seeking massive reconstruction after mastectomy, the cohesive gel will probably not offer the best results.

Silimed's implant was given the "gummy bear" implant nickname, for the obvious reason that the inside gel material is of about the same consistency. It's a form stable implant that can be handled and squeezed with human hands without rupturing, and will return to its original shape immediately. And, as you might imagine, Dr. Kress says that "the satisfaction rate is incredibly high."

The Surgery, The Results, and What Lies Ahead

So, okay, here's how the surgery works. Because the implant won't fold like other types, it has to be placed through an incision made at the lower breast crease; an incision that Dr. Kress says is virtually invisible in all of his 160 cases so far. The implant is placed between the breast gland and pectoral muscle, the incision sewn up, and viola! Surgery over. Of course, it's not quite that easy. There is certainly some amount of pain, it may take a few weeks until the breasts are looking the way they should, and Dr. Kress's patients aren't going back to work any sooner than they would with saline or traditional silicone implants.

There are also possible complications. In addition to the possibility of a blood clot, infection, and other possible problems that accompany any major surgery performed under general anesthesia, there is also the possibility of wrinkling and capsular contracture, in which scar tissue surrounding the implant collapses around it, making it feel hard, although instances of both are way down compared to other types. And don't forget about women who still aren't happy with the way they look afterwards. Dr. Kress has re-operated on one woman because she thought that her breast were too big and wanted to go smaller, another who thought that hers were too small and wanted bigger, and one who had a knot on the upper part of one breast due to scar tissue. Compared to much higher saline re-operation rates and other complications, that's not bad, but remember, it has only been a year and there are still no long-term studies of how the implants perform years and decades down the road.

So What's Available Now?

This new-style cohesive gel implant is available only to patients taking part in FDA trials, and there are only 23 doctors, including Dr. Kress, that can perform implantation with the Silimed product as a part of these trials. As clinical studies progress, the company will eventually seek FDA approval, and when, and if, this occurs, the implant will be available on a wider scale. But for now, commercially speaking anyway, we stick with our safety-conscious "sacks of water."