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| Protocol Number: |
WIRB # 96564 |
| Trial Phase: |
Phase I |
| Maximum # of Subjects: |
20 |
| IRB Number: |
WIRB # 1048806 |
| Study Status: |
Active |
| Enrollment Status: |
Open |
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| To gather safety data regarding short term, post-implant events and complications needed to support Premarket Approval (PMA) submissions for Mentor H/S Silicone Gel-Filled Mammary Prostheses and to maintain a comprehensive record of the patient's outgoing medical history. |
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Eligibility |
Inclusion Criteria: 1. Must be females at least 18 years of age.
2. Must have one or more of the following breast conditions:
a. Post-unilateral or bilateral mastectomy (immediate or delayed) as a result of cancer or other disease process.
b. Require reconstruction due to cancer treatments other than mastectomy.
c. Require a revision due to complications or other undesirable results of a previous surgery for the above reasons.
d. Post-Trauma defined as total or partial removal of the breast(s) through surgery (for any reason) or as a result of the trauma itself.
e. Congenital deformities such as:
- Pectus Excavatum defined as congenital concave chest wall deformity with abnormalities of the sternum and anterior ribs.
- Pectus Carinatum defined as convex chest wall deformity with abnormalities of the sternum and anterior ribs.
- Severe asymmetry defined as congenital or acquired substantial discrepancy in breast sizes such as to represent a significant physical deformity or abnormality (e.g. Poland’s syndrome).
f. Severe ptosis defined as requiring a specific reconstruction procedure (i.e. mastopexy).
g. 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.
h. Replacement or revision for patients whose prior surgery was not a result of treatment for cancer and for whom saline implants are unsuitable (e.g. skin too thin, insufficient tissue, etc.) as deemed by surgeon.
i. Patients who require Augmentation mammaplasty in the unaffected breast as a result of the surgery, due to one of the above indications, in the affected breast (i.e. unilateral mastectomy with augmentation to opposite breast to provide symmetry.
j. Special circumstances for implantation will be considered on a case by case basis per written FDA authorization.
3. Conditions must be such that saline implants are unsuitable for the patient as deemed by the surgeon.
4. Must be willing to follow the study requirements to include:
a. Signing of Informed Consent Document.
b. Agreeing to complete all required follow-up visits.
c. For those patients participating in the Patient Registry: agree to conditions of Implant Registry and follow the requirements of the Registry program.
d. Agreeing to follow Mentor H/S Standard Operating Procedures for explant Analysis on any device(s), which may require removal throughout the duration of the study.
e. Must be determined by the investigator and other medical specialists (as required) to be an acceptable candidate for reconstructive breast surgery. General medical condition and history, as well as psychological appropriateness should be considered before surgical intervention.
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Exclusion Criteria: 1. Have an abscess or infection anywhere in the body at the time of study entry.
2. Be currently pregnant or nursing.
3. Be diagnosed as having lupus (e.g. Systemic Lupus Erythematosus or Discoid Lupus), scleroderma (e.g. Progressive Systemic Sclerosis).
4. Currently have uncontrolled diabetes or any diseases which are clinically known to impact wound healing ability.
5. Demonstrate tissue characteristics, which are clinically incompatible with mammaplasty (e.g. tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration).
6. Possess any condition or currently be under treatment for any condition, which in the opinion of the plastic surgeon and/or consulting physician(s), may constitute an unwarranted surgical risk.
7. Demonstrate psychological characteristics such as inappropriate attitude or motivation, which in the opinion of the surgeon are incompatible with the risks involved with the surgical procedure and the prosthesis.
8. Augmentation mammaplasty and the failure to have at least one of the diagnoses identified in the inclusion criteria.
9. Unwillingness to undergo any further surgery for revision (if required).
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