Mentor MemoryGel Post-Approval Study (MGPAS)

Mentor Worldwide

Status: Completed

Conditions: Breast Reconstruction; Breast Revision; Breast Augmentation

Treatments: Device: Mentor Silicone Gel-Filled Breast Implants; Device: Saline Breast Implants

Study type: Observational

Funder types: Industry

Identifiers

NCT00756652

P030053

Details and patient eligibility

About

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.

Enrollment: 42,491 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

42,491 participants in 2 patient groups

MemoryGel Breast Implant Participants

Description:

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

Treatment:

Device: Mentor Silicone Gel-Filled Breast Implants

Saline Breast Implant Control Participants

Description:

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

Treatment:

Device: Saline Breast Implants