- Females of any age for which breast reconstruction is considered appropriate.
(Patients under 18 years old require parental/legal guardian consent to participate).
- Have any of the following conditions or situations present:
- Post mastectomy surgical removal of the breast for cancer or other diseases;
- Post trauma or post surgery where there was total or partial removal of the
breast resulting in significant deformity.(for any reason);
- Severe ptosis requiring reconstruction (i.e. mastopexy);.
- 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, but are not limited to:Pectus excavatum, Pectus
carinatum; Thoracic hypoplasia (Poland's syndrome, Scoliosis; Isolated rib
deformities; Tuberous breasts; Congenital absence
- 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. rapture or significant capsular contracture
(Baker Grade III or IV) requiring revision;
- 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.
- Adequate tissue available to cover implants.
- Saline-filled implants are not an appropriate choice.
- 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.
- Advanced fibrocystic disease considered to be premalignant-without accompanying
- Existing carcinoma of the breast, without mastectomy.
- Abscess or infection in the body at the time of enrollment.
- Pregnant or nursing.
- Have any disease, including uncontrolled diabetes; which is clinically known to
impact wound healing ability.
- Show tissue characteristics which are clinically incompatible with mammaplasty, such
as tissue damage resulting from radiation, inadequate tissue, compromised vascularity
- Have, or under treatment for, any condition which, in the opinion of the surgeon, may
constitute an unwarranted surgical risk.
- 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.
- Wish to have augmentation mammaplasty, but do not have at least one of the diagnoses
identified in Patient Inclusion Criteria item G #2, pages 7 & 8.
- Are not willing to undergo 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 wrinkling.