Study of the Safety and Effectiveness of the Mentor Becker Expander/Breast Implant in Subjects Who Are Undergoing Primary Breast Reconstruction
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 Pre-market 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 pre-market 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 subjects. Every subject implanted had to be part of an adjunct study, in addition
to being offered participation in a registry of gel-filled breast implant subjects. In
order to be implanted with gel-filled implants for augmentation, women had to be enrolled in
an IDE clinical trial.
A PMA for Mentor's MemoryGel™ Silicone Gel-Filled breast implants (which did not include the
Becker Expander/Breast Implants) was subsequently filed with FDA in December 2003, and
approved in November 2006 (P030053). As a condition of approval of P030053, new enrollment
in Mentor's Adjunct Study has ceased, and women no longer have access to the Becker
This study is designed to evaluate the safety and effectiveness of Mentor's Becker
Expander/Breast Implants for primary breast reconstruction
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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 per subject basis.
Alexander Digenis, M.D.
United States: Food and Drug Administration