Cohesive Implants FAQ’s
What are Cohesive Implants?
The standard implant in the United States since 1992 has been the saline-filled implant. The FDA placed a moratorium on silicone implants due to safety concerns. However, cohesive implants have been available outside the United States for the past 10 years. They have not yet been approved by the FDA. They are available only in the course of clinical trials in the United States.
Cohesive implants are different from silicone implants in that cohesive implants contain a thicker gel. They have been called “gummy bear implants” due to the consistency of the gel they contain. This gel allows the implants to keep their shape. They are not affected by gravity and movement. They are also less likely to leak than are traditional implants. If cut in half, cohesive implants are still able to maintain their shape.
Which Surgeons Can Use Cohesive Implants in the United States?
Of the three U.S.-based companies that are performing clinical studies, only a small percentage of surgeons are allowed to order the implants and use them on study participants.
Which Patients Can Receive Cohesive Gel Implants in the United States?
Since cohesive implants are available in the U.S. only in clinical trials, patients wishing to receive them must do so as part of a study. These patients must agree to follow-up with their doctor for the length of 10 years. Some women may view the participation in the study as a way to receive advanced medical treatment while being reimbursed for medical expenses. Others may not feel comfortable participating in a study when all the risks may not be known.
Do Cohesive Implants Come With a Smooth or Textured Surface?
The surface of a cohesive implant is textured to prevent it from moving around by increasing friction. The company Silimed makes an implant with a smooth surface, however, these implants are not used in the United States.
What Happens if a Cohesive Implant Ruptures?
There is not much information on ruptures, and therefore, it is not completely known what would happen. It is likely that, because of the gummy consistency of the gel, that the gel would stay in place with minimal leaking. There is an ongoing investigation into this issue and more research is needed in this area.
How Can You Detect a Leak in a Cohesive Implant?
Because of the thick consistency of the gel, it would likely be difficult to know if the implant has ruptured. An MRI or mammogram may be able to determine if there is a leak.