Mentor cpg clinical trial

This follow-up requirement changed from 10 years to 5 years upon device approval. The CPG implant contains a gel that is a more cohesive silicone gel than that used in other Mentor gel implants. The gel is made from the same materials as Mentor's standard gel. The contour shape of the CPG is designed to provide inferior projection with reduced superior fullness.

The CPG mammary prosthesis contains raised orientation marks on the anterior and posterior of the implant which may help the physician ensure proper placement. CPG was available in sizes cc cc and 5 styles with various projection and height options.

Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Pre-assignment Details. The Primary Augmentation cohort wil Period Title: Overall Study. Not Completed. Reason Not Completed. Total of all reporting groups. Baseline Analysis Population Description.

American Indian or Alaska Native. Native Hawaiian or Other Pacific Islander. United States. Time of occurrence calculated as the number of days from the date of t Baker III was identified as "firm with visible distortion" a Baker III was identified as "firm with visible distortion" and Baker IV was identified as "obvious spherical distortion".

Change in Chest Size was calculated by subtracting the chest circumfer 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. Baseline Surgery to 10 Years. Primary Augmentation. Primary Reconstruction. Revision Augmentation. Revision Reconstruction. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.

Federal Government. Read our disclaimer for details. Results First Posted : November 11, Last Update Posted : November 11, Study Description. Safety information on the rate of capsular contracture, rupture and infection will be collected and used to determine device safety. Detailed Description:. FDA Resources.

Arms and Interventions. Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.

Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.

Outcome Measures. Patients were censored as of the date of their last office visit, the month time point, or the date of explantation of all initial study devices, whichever was earliest. 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.

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.

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. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.