In This SectionTexas Health Research & Education Institute
Disease or Condition
MEMORY GEL PAS (Plastic Surgery)
Breast Implant Post - Approval Study.
Is a candidate for breast augmentation with Mentor Memory Gel breast implants and is atleast 22 years old (primary or revision) OR is a candidate for breast reconstruction (primary or revision) with Mentor Memory Gel breast implants.
Signs an acknowledgement of informed decision from the patient brochoure.
Signs an informed consent form and authorization to disclose health information and release medical records.
Completes the baseline questionaire (as evidenced by the participant's signature on the last page of the questionaire).
Agrees to authorize return of the device(s) to Mentor if the device is explanted.
Agrees via informed consent to comply with study follow up questionaire and responding to quesationnaires in their entirety.
Is a U.S. resident.
Has an infection anywhere in her body.
Has existing breast cancer or pre-cancer of the breast without adequate treatment for thos conditions.