Mentor MemoryGel Post-Approval Study

Breast Reconstruction Clinical Trial

— MGPAS  

Official title:

MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756652
• Other study ID #: P030053
• Status: Completed
• Start date: November 1, 2006
• Est. completion date: July 31, 2019

Study information

• Verified date: June 2020
• Source: Mentor Worldwide, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT00495534

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42491
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female, age 18 years or older (22 or older for breast augmentation patients)

2. U.S. resident

Exclusion Criteria:

1. If a saline participant, current or past, unilateral or bilateral, silicone breast implants

2. Active infection anywhere in her body

3. Existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions

4. Currently pregnant or nursing

Related Conditions & MeSH terms

• Breast Augmentation
• Breast Reconstruction
• Breast Revision

Intervention

Device:
• Mentor Silicone Gel-Filled Breast Implants

• Saline Breast Implants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mentor Worldwide, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Reasons for Reoperations	Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years	10 Years