Are Cohesive Breast Implants FDA Approved?

asked 2 years ago by anon
Latest answer by Steven Wallach, MD
Question viewed 631 times
Tags: FDA

Doctors: I read on a cohesive breast website that these breast implants are much better. it looked like they arent arppoved. is the fda close to approiving them?

6 answers to Are Cohesive Breast Implants FDA Approved?

Highly cohesive-form stable implants-Allergan style 410

You are probably referring to the Allergan style 410 or the Mentor CPG device. It is still uncertain when they will be approved by the FDA. They have been in use since 1994 and are currently used without restriction in Canada, Australia, Europe-essentially everywhere but the United States. In my experience using the devices, they may have several advantages for some patients. Although they won't be for everyone. Technically all silicone devices are "cohesive". The degree of... more

John E. Gross, MD
Los Angeles Plastic Surgeon

Cohesive implants

Cohesive gel implanta are not approved for general use in the US. They are stil on research protocol.

Steven Wallach, MD
Manhattan Plastic Surgeon

Cohesive breast implants.

Hi! In NYC, we use MemoryGel breast implants made by Mentor. These are cohesive, they are FDA approved, and they are the #1 preferred breast implant in the US market today. If you cut these implants in half, all the gel remains in place and does not leak. That is what cohesive means. There are also clinical trials on "form stable" or "gummy bear" implants. These are not FDA approved and will not be for the foreseeable future. These implants are hard (like a gummy bear... more

George J. Beraka, MD
Manhattan Plastic Surgeon

Cohesive gel implants are still waiting for FDA approval.

Cohesive gel implants are available in Europe but are not yet in the USA. If they are made available in the USA they will widen the range of options for patients . They are shaped implants and are also reported to be somewhat firmer than the current silicone implants available in the USA. Plastic surgeons will have more options to explore with their patients as to which implant (gel, shaped gel, saline ) is the best implant for them. I would recommend talking to a plastic surgeon as... more

Susan E. Downey, MD
Los Angeles Plastic Surgeon

Not sure when FDA will approve cohesive implants

I'm not sure anyone can tell you when the FDA will clear these implants. You should keep in mind that these are shaped implants that will provide volume to the upper pole of the breast. They may not be appropriate for every patient.Having said that, there are surgeons in this country that are using these implants as part of the study. If you are very interested, you could inquire of our society (American Society of Plastic Surgeons) about surgeons in your area enrolled in the study.Good... more

Jeffrey Horowitz, MD
Baltimore Plastic Surgeon

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