CompletedNot Applicable

Mentor MemoryGel Post-Approval Study

42,491 participantsStarted 2006-11-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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

What they're measuring

Kaplan Meier Estimated Cumulative Incidence of Reported Complications

Timeframe: 10 years

Kaplan Meier Estimated Cumulative Incidence of Explantation

Timeframe: 10 years

Trial details

NCT IDNCT00756652

SponsorMentor Worldwide, LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-07-31

Results submitted2020-03-27

View on ClinicalTrials.gov More Breast Reconstruction trials