CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)

Launched by MENTOR WORLDWIDE, LLC · Oct 8, 2013

Keywords

ClinConnect Summary

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 pre-market 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 marketin...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Subject is genetic female, 18 years of age or older
• • A candidate for: Primary breast augmentation (general breast enlargement), Primary breast reconstruction (for trauma, loss of breast tissue due to mastectomy, malignancy, contralateral post-reconstruction symmetry, congenital deformity, including asymmetry), or Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants)
• • Signs the Informed Consent
• • Agrees to return device to Mentor if explant necessary
• • Agrees to comply with follow-up procedures, including returning for all follow-up visits
• Exclusion Criteria:
• • Subject is pregnant
• • Has nursed a child within three months of study enrollment
• • Been implanted with any silicone implant other than breast implants (e.g. silicone artificial joints or facial implants)
• • Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondylarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
• • Currently has a condition that could compromise or complicate wound healing (except reconstruction subjects)
• • Subject in Augmentation cohort and has diagnosis of active cancer of any type. (Exception is low-grade non-metastasizing skin cancer)
• • Infection or abscess anywhere in the body
• • Demonstrates tissue characteristics which are clinically incompatible with implant (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity)
• • Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
• • Anatomic or physiologic abnormality which could lead to significant postoperative adverse events
• • Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure
• • Premalignant breast disease without a subcutaneous mastectomy
• • Untreated or inappropriately treated breast malignancy, without mastectomy
• • Are HIV positive
• • Work for Mentor or the study doctor or are directly-related to anyone that works for Mentor or the study doctor