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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Plastic Surgery
Title   MEMORY GEL PAS (Plastic Surgery)
Description   Breast Implant Post - Approval Study.
IRB Number   Pro290
Inclusion/Notes   INCLUSION:
  • 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.

EXCLUSION:
  • Has an infection anywhere in her body.

  • Has existing breast cancer or pre-cancer of the breast without adequate treatment for thos conditions.

  • Is currently pregnant or nursing.
Status   Completed
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    Harlan Pollock MD
Contact Name   Joanne Mendenhall
Phone   (214) 363-2575

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