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| Protocol Number: |
Version 12.10.97 |
| Trial Phase: |
Phase I |
| IRB Number: |
WIRB # 980510 |
| Study Status: |
Active |
| Enrollment Status: |
Open |
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| Coordinator: |
Kim
Pickard
RN
(502) 894-9900
(502) 894-9922
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| This study is designed to collect 5 year data about possible health problems associated with breast implants. These data will be used to help determine if these implants are both safe and effective. If they are proven safe and effective, they will continue to be available. If the data from the studies does not show that they are safe and effective to the satisfaction of the FDA, they may not be available in the future. |
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Eligibility |
Inclusion Criteria: 1. Females of any age for which breast reconstruction is considered appropriate. (Patients under 18 years old require parental/legal guardian consent to participate.)
2. Have any of the following conditions or situations present:
a. Post mastectomy surgical removal of the breast for cancer or other diseases;
b. Post trauma or post surgery where there was a total or partial removal of the breast resulting in significant deformity (for any reason);
c. Severe ptosis requiring reconstruction (i.e. mastopexy);
d. Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity. This does not include normal variants of asymmetry. Examples include, are not limited to, those listed below:
- Pectus excavatum - congenital concave chest wall deformity with abonormalities of the sternum and anterior ribs;
- Pectus carinatum - congenital convex chest wall deformity with abnormalities of the sternum and anterior ribs;
- Thoracic hypoplasia (Poland's syndrome) - congenital chest wall deformity with underdevelopment of the ribs and breast on one side;
- Scoliosis - congenital or acquired curvature of the spine which may result in a substantial compensatory deformity of the sternum and anterior ribs;
- Isolated rib deformities - congential or acquired absence or distortion of isolated ribs which may produce an anterior chest wall deformity;
- Tuberous breasts - usually congenital development deformity of one or both breats characterized by an abnormal appearing breast with an enlarged pedunculated and protuberant nipple combined with a constricted breast base circumference;
- Congenital absence - a typically unexplained absence of one or both breasts;
e. Revision of implant procedure due to any of the following circumstances;
- Previous augmentation or reconstruction with silicone - or saline-filled implants where problems exist, such as implant rupture or significant capsular contracture (Baker Grade III or IV) requiring revision;
f. Contralateral mammaplasty in unaffected breast as a result of the affected breast requiring surgery (for one of the aforementioned circumstances), when medically indicated to provide symmetry.
3. Adequate tissue available to cover implants.
4. Saline-filled implants are not an appropriate choice.
5. Willingness to follow all study requirements, such as agreeing to all required follow-up visits, and acceptance of the risks involved as indicated by signing of the Patient Informed Consent document.
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Exclusion Criteria: 1. Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
2. Existing carcinoma of the breast, without mastectomy.
3. Abscess or infection in the body at the time of enrollment.
4. Pregnant or nursing.
5. Have any disease, including uncontrolled diabetes, which is clinically known to impace wound healing ability.
6. Show tissue characteristics which are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration.
7. Have, or under treatment for, any condition which, in the opinion of the surgeon, may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation.
8. Show psychological characteristics which, in the opinion of the surgeon, may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation.
9. Wish to have augmentation mammaplasty, but do not have at least of one of the diagnoses identified in Patient Inclusion Criteria item G # 2, pages 7 & 8.
10. Are not willing to undergo further surgery for revision, if medically required.
11. Diagnosis of lupus or scleroderma.
12. Replacement of saline-filled implants solely for a less than desirable cosmetic outcome, such as wrinkling. |
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