The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety. Approximately 1000 patients at centers across the United States will be enrolled in this research study. These patients will be implanted with silicone breast prostheses and monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.
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 clinical study. 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,008
Two types of Mentor Round Low-Bleed Silicone Gel-filled Mammary Prostheses will be used in the study: the Siltex textured surface device and the smooth surface device. Each implant is a silicone elastomer (rubber) mammary device that is supplied individually packaged in a doubled wrapped packaging system, sterile, and non-pyrogenic (does not cause fever). Each device consists of a silicone shell encasing a silicone gel filler material with a patch on the posterior side of the device. The basic smooth device shell consists of a silicone layer sandwiched in between two other silicone layers. This construction acts as a barrier to slow the diffusion of (spread) any gel filler materials through the shell. The Siltex textured shell consists of a smooth shell to which is bonded an additional layer of silicone with a textured pattern imprinted into its surface. The Siltex shell is intended to prevent tissue ingrowth. The implants will be available in sizes 100cc through 800ccs.
Mentor Worldwide, LLC
Santa Barbara, California, United States
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Time frame: 10 years
Overall Mean Change in Circumferential Chest Size
Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study
Time frame: Change from baseline to 10 years post-baseline
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture
Baker III was identified as "firm with visible distortion" and Baker IV was identified as "obvious spherical distortion". Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Time frame: 10 Years
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Time frame: 10 Years
10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
Time frame: 10 Years
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