Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis
Mentor is undertaking a five-year prospective clinical study designed to collect safety data associated with the implantation of its gel-filled mammary prostheses. This study is an "adjunct" study, which will encompass clinical reviews of reconstructive cases in all patients who meet clinical and regulatory criteria for breast reconstruction with gel-filled mammary prostheses. This "adjunct" study will be accomplished under a limited clinical protocol in which specific parameters will be required but with controls somewhat less stringent than those normally required in Investigational Device Exemption (IDE) Trials.
|Study Type:||Expanded Access What is Expanded Access?|
|Official Title:||Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis|
Device: Silicone Gel-Filled Mammary Prostheses
- Gel-filled device which is available in smooth surface and textured surface (Siltex®)
- Becker Expander/Mammary Prosthesis which is available in both the smooth and the textured (Siltex) version
Mentor Gel-Filled Mammary Prostheses are comprised of a shell made of medical grade silicone elastomer. Gel-filled implant devices manufactured by Mentor will be used in this study:
Both of these devices were originally indicated for both augmentation and reconstruction mammaplasty procedures, however for purposes of this study, indications are for reconstruction only.
Objectives of this study are to gather safety data regarding short term, post-implant events and complications needed to support Premarket Approval (PMA) submissions for Mentor Silicone Gel-Filled Mammary Prostheses and to maintain a comprehensive record of the patient's ongoing medical history. The FDA has placed the devices in a regulatory category as a Class III device, pursuant to the Medical Device Amendments to the Federal Food and Drug Act which went into effect in May 1976. For devices in this class, FDA requires certain clinical data regarding the risks associated with mammary prostheses. Due to several issues surrounding possible risks of silicone gel-filled breast implants, the FDA has mandated specific clinical study requirements to further assess possible risks and complications of silicone devices. Clinical data collected via this study will supplement data which will be collected in more extensive "Core" studies for breast reconstruction and augmentation procedures.
Primary Objective - Safety Assessment
Specifically, data collected during this study will provide risk and complication data with regard to short-term use of silicone breast implants. This safety assessment will include, but is not limited to:
- Incidence of capsular contracture
- Occurrence of complications such as infection and seroma
- Rupture rates for the implant
This study is not intended to assess rare, long-term or speculative conditions which are not proven clinically to be associated with mammary prostheses, such as their relationship to Connective Tissue Disorders, an increased risk of cancer or teratogenic effects among breast implant patients. This study is also not intended to address issues regarding the effects of breast implants on mammography interpretation and occurrence of calcium deposits in the tissue surrounding the implant. However, data on these and other complications noted in this study, should they occur, will be recorded and analyzed with regard to the objective of the study.