FAQs: Cohesive Gel Breast Implant Study – Breast Augmentation

Cohesive Gel Breast Implant Study

Many thanks to Steven Teitelbaum, M.D. of Beverly Hills, CA for this contribution.

NOTE: In the United States, cohesive implants are investigational devices, and are available only to select surgeons, and patients participating in clinical trials.

Dr. Teitelbaum has had a keen interest in the field of cohesive gel breast implants, and has lectured about them to other plastic surgeons. He is the only physician selected to be a participant in all 3 clinical trials being conducted in the United States on cohesive silicone gel breast implants: these include implants made by Inamed (formerly McGhan), Mentor, and Silimed. Enrollment is ongoing for a limited time in all three of these trials.

Because participants must be available for annual follow-up for 10 years, Dr. Teitelbaum will only enroll patients in the Southern California area; patients from other areas should contact Mentor Silimed or Inamed to find a surgeon in their area.

A cohesive implant - and even a piece of it should maintain its shape even when cut apart. The thick gel does not "run."

Cohesive breast implants were invented in the early 1990s, and have been used throughout the world for about 10 years. Only the United States has yet to approve these devices. Though the experience of these implants overseas will be taken into account, the FDA requires that a prospective large-scale study be done in the United States, adhering to their rigorous guidelines and scrutiny. These implants are not approved by the FDA. It is only in the context of such a study that these implants are available in the United States.

These implants were originally invented with 2 purposes in mind: 1) to make a longer- lasting implant, and 2) to make an implant that would maintain a more attractive and predictable shape. This goal is primarily achieved by making the gel more cohesive, so that it is less liquid-like and more solid than other silicone gel implants. For this reason, they have been known as the "gummy bear implants". Though preliminary data suggests these implants might be meeting its goals, prospective enrollees must understand that these claims have not yet been proven.

Three companies are currently doing clinical trials in the United States: Inamed, Mentor, and Silimed. Each company's devices are based upon similar concepts, but there are very significant differences between them.

Some women consider this an opportunity to have a chance to be the first to get what may be the implant of the future, while other women feel uncomfortable being a participant in a study of a new medical device. Only women highly motivated to receive these implants, and who are willing to participate in the study for 10 years of follow-up, should consider these devices.