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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Plastic Surgery
Title   McGhan Medical Corporation Silicone-Filled Breast Implant Adjunct Clinical Study (Plastic surgery)
Description   Long term study of silicone-filled breast implants.
IRB Number   Pro224
Inclusion/Notes   INCLUSION:
  • The characteristics of the subjects are limited only to female, There are no backgroung exclusion.

  • Patients will be eligible for inclusion in the study if surgery has been recommended by the consulting plastic surgeon and they meet the following criteria.

  • Female of any age for which beast reconstruction is approriate. (If under the age of 18 parent or legal gaurdian consent needed)

  • Have any of the following conditions or situations present:
    a. Post mastectomy surgical removal of the breast for cancer or other disease.
    b. Post trauma or post surgical where there was total or partial removal of the breast resulting in siginificant deformity.
    c. Severe ptosis requiring rconstruction.
    d. Any congenital or aquired discrepancy in the breast size such as to represent a significant physical deformity.
    e. Revision of implant procedure die to previous augmentation or reconstruction with silicone or saline filled implant where a problem exsist, such as implant rupture capsular contracture (Baker III or Baker IV requiring revision) f. Contralateral mammaplasty in unaffected breast as a result of the afffected breast requiring surgery, when medically indicated to provide symmetry.

  • Adequate tissue available to cover implants.

  • Saline-filled implants are not appropriate choice.

  • Willingness to follow all study requirements, such as agreeing to all required follow up cisits, and acceptance of all risks involved as indicated by signing of the Patient Informed Consent.

EXCLUSION:
  • Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastevetom.

  • Existing carcinoma of the breast without mastectomy.

  • Abcess or infection on the body at the time of enrollment.

  • Pregnant or nursing.

  • Have any, including unctrolled diabetes, which is clinically known to impact wound healing ability.

  • Show tissue characteristics which are clinically incompatible with mammoplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration.

  • Have, or under treatment for, any condition which, on the opinion of the surgeon, may constitue an unwarented surgical risk.

  • Show psychological characterisitics which, in the opinion of the surgeon, may be incompatible with the surgical procedure and the prosthesis, such as inappropriate atitude or motivation.

  • Wsh to have augmentation mammaplasty,but do not have ate least one of the diagnoses identified in Patien Inclusion Criteria it G#2 pages 7 & 8.

  • Are not willing to indergo further surgery for revision, if medically required.

  • Diagnosis of lupus or scleroderma.

  • Replacement of saline-filled implants solely for a less than desirable cosmetic outcome, such as walking.
Status   Completed
Location   Texas Health Harris Methodist Hospital Fort Worth
Principal Name    Louis Leighton Strock MD
Contact Name   Elena Broyles
Phone   (817) 335-1616

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