Continued Access Study of the Mentor Becker Expander/Breast Implant
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
The Mentor Becker Expander/Breast Implant was used throughout the United States during this
time (since 1992) under the Mentor Adjunct Study to allow continued access to the device and
to collect some safety information, however was not evaluated in the MemoryGel Core Study.
The gel fill used in the MemoryGel implants is the same gel fill that is used for the Becker
This protocol describes the study design procedures and population for a Continued Access
(CA) Study for the Mentor Becker 25 and 50 Expander/Breast implants. While Core Becker
patient follow-up is being completed, this CA Study is designed to enroll patients at a
limited rate per month to allow for continued physician experience with the device. The
safety data obtained may be used to provide supplemental information to the PMA. It will be
requested that this study be initiated and renewed every six months until a final decision
is reached regarding the Becker PMA.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety will be determined by incidence, severity, method of resolution, and duration for all adverse events on a per implant and per subject basis
Mark A. Walker
United States: Food and Drug Administration
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