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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Plastic Surgery
Title   MENTOR SILICONE GEL-FILLED H/S ADJUNCT STUDY (Plastic Surgery)
Description   Review of the safety of silicone breast implants.
IRB Number   Pro111
Inclusion/Notes   INCLUSION:
  • Female patients 18 years of age or older.

  • Immediate or delayed breast reconstruction mastectomy.

  • Reconstructuion due to cancer treatments other than mastectomy.

  • Revision due to complications or other undiesirable results of a previous surgery for mastectomy or cancer treatments other than mastectomy.

  • Post-Trauma defined as total or partial removal of breast(s) through surgery (for any reason or as a result of trauma itself.

  • Congenital deformities: Pectus excavatum defined as congenital concave chest wall deformity abnormalities of the sternum and anterior ribs; Pectus carinatum defined as congenital covex chest wall deformity with abnotmalities of the sternum and anterior ribs; and severe asymmetry defined as congenital or aquired substantial discrepancy in breat sizes such as to represent a signifigant physical deformity (e.g., Polands syndrom)6.Severe ptosis defined as requiring a specific reconstruction procedure (e.g., mastopexy).

  • Patients who require revision for implant replacement for severe deformity caused by medical or surgical complications regardless of original indication for implantation or type of device originally implanted.

  • Patients who require augmentation mammaplasty in the uinaffected breast as a result of surgery, due to one of the above indications, in the afected breast (e.g., unilateral mastectomy with augmentation to opposite breast to provide symmetry).

  • Replacement or revision for patients whose prio surgery was not a result of treatment for cancer and for whome saline implants are unsuitable (e.g., skin too thin, insufficient tissue, ect.) as deemed by the surgeon.

  • Special circumstances for implantation will be considered on a case-by-case basis per written FDA authorization.

  • Determined by a physician not to be a candidate for saline-filled mammart implants, due to skin being too thin, insufficient tissue, ect.

  • Patient must be willing to follow the Study requirments.

EXCLUSION:
  • An active infection or abcess anywhere in the body.

  • Pregnancy or nursing mothers.

  • Lupus (e.g., SLE and DLE).

  • Sceroderma (e.g., progressive systemic sclerosis).

  • Uncontrolled diabetes or other diseases which impacts healing.

  • Tissue characteristics which are clinically incompatible with mammaplsty (e.g., tissue damage resulting from raiation inadequate tissue, comprised vascularity or ulceration).

  • History of sensitivity to foreign material or repated attempts and failures at brest reconstruction or augmentation.

  • Posses any condition or currently be under the treatment for any condition which, in the plastic surgeon's and/or consulting physicians'(s) opinion may constitute unwarranted surgical risk.

  • An unwillingness to under go any further surgery for revision.

  • Psychological characteristics such as inappropriate attitude or motivation which, in the surgeon's opinion are incompatible with the surgical procedure and prosthesis.

  • Augmentation mammaplasty and the failure to have at least one of the diagnoses identified in the inclusion criteria.
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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