Mentor MemoryGel Post-Approval Study

NCT00756652 | Completed Results

• 1 other identifier: P030053
• Study Type: observational
• Target: 42,491
• Locations: 0 countries
• Sites: N/A

Brief Summary

In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional breast reconstruction surgery. This postapproval study is intended to satisfy one element of FDA's postapproval monitoring requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of data collection for the study to the collection of only secondary procedure/reoperation data for MemoryGel participants.

Conditions

Breast Reconstruction; Breast Augmentation; Breast Revision

Outcome Measures

Primary Outcomes (2)

• Kaplan Meier Estimated Cumulative Incidence of Reported Complications

  The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.

  10 years

• Kaplan Meier Estimated Cumulative Incidence of Explantation

  The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.

  10 years

Secondary Outcomes (1)

• Reasons for Reoperations

  10 Years

Study Arms (2)

MemoryGel Breast Implant Participants

MemoryGel Breast Implant Participants received Mentor Silicone Gel-Filled Breast Implants (MemoryGel) during their Breast Augmentation, Breast Reconstruction, or Revision surgery

Device: Mentor Silicone Gel-Filled Breast Implants

Saline Breast Implant Control Participants

Saline Breast Implant Control Participants received Saline Filled Breast Implants during their Breast Augmentation, Breast Reconstruction, or Revision surgery

Device: Saline Breast Implants

Interventions

Mentor Silicone Gel-Filled Breast Implants DEVICE

Also known as: MemoryGel Breast Implants

MemoryGel Breast Implant Participants

Saline Breast Implants DEVICE

Saline Breast Implant Control Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MemoryGel™ PAS uses a current cohort design of 41,900 gel participants and 1,000 saline participants.

You may qualify if:

• Female, age 18 years or older (22 or older for breast augmentation patients)
• U.S. resident

You may not qualify if:

• If a saline participant, current or past, unilateral or bilateral, silicone breast implants
• Active infection anywhere in her body
• Existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions
• Currently pregnant or nursing

Sponsors & Collaborators

• Mentor Worldwide, LLC: lead

Limitations and Caveats

The data presented may represent an under-estimation of reoperation and explantation rates due to the lack of mandatory safety reporting and ability for participants to be treated at non-study sites.

Results Point of Contact

• Title: Sponsor
• Organization: Mentor Worldwide, LLC

mgpas@its.jnj.com

949-453-6408

Study Officials

• John Canady, M.D.

  Mentor Worldwide, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 22, 2008
• Study Start: November 1, 2006
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-06