Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses in Patients Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction or Revision
Silicone gel-filled breast implants were introduced in the early sixties and were in
wide-scale distribution by the time the Medical Device Amendments to the Food Drug and
Cosmetic Act was passed in 1976. In 1983, gel-filled breast implants were designated as
Class III devices requiring premarket approval. In May 1990, the Food and Drug
Administration (FDA) published a proposed request (515(b)) for Premarket Approval
Applications (PMA) and in April 1991 published the final request. This final publication
put manufacturers of gel-filled breast implants on notice that for continued marketing of
gel-filled breast implants, a PMA was due to FDA in 90 days from the final publication date.
A premarket approval (PMA) for the Mentor gel-filled breast implants was filed with the FDA
in July 1991. At the FDA General and Plastic Surgery Advisory Committee meeting in November
1991, the committee recommended the submission of additional information to establish the
safety and effectiveness of gel-filled breast implants.
In January 1992, the FDA Commissioner announced a voluntary moratorium of the sale of
gel-filled breast implants to allow the advisory panel time to assess additional
information. In April 1992, the moratorium was lifted but only for reconstruction and
revision patients. Every patient implanted had to be part of an adjunct study, and had to
be offered participation in a registry of gel-filled breast implant patients. In order to
be implanted with gel-filled implants for augmentation, women had to be enrolled in a core
The objective of this study is to determine the safety and effectiveness of the smooth and
textured surface Mentor Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who
are undergoing primary breast augmentation, primary breast reconstruction or revision.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety will be determined by the incidence, severity, method of resolution, and duration for all adverse events on a per implant and a per patient basis.
United States: Food and Drug Administration
|Mentor Worldwide, LLC||Santa Barbara, California 93111|