McGhan Medical Silicone-Filled Breast Implant Adjunct Study

NCT00581984 | Completed

• 1 other identifier: 98-089
• Study Type: observational
• Target: 1,016
• Locations: 1 country
• Sites: 1

Brief Summary

This study will collect 5 year data about any possible health problems associated with breast implants. This data will be used to help see if the implants are both safe and effective. If they are proven safe and effective, they will continue to be available. If they are not proven safe and effective to the satisfaction of the FDA, they may not be available in the future.

Conditions

Breast Reconstruction With Silicone Implants

Keywords

breast cancer; breast reconstruction; silicone implants

Outcome Measures

Primary Outcomes (1)

• Evidence of breast implant complications

  10 years 3 months

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females who are candidates for breast reconstructio

You may qualify if:

• 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.

You may not qualify if:

• Advanced fibrocystic disease considered to be premalignant-without accompanying subcutaneous mastectomy.
• 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 or ulceration.
• 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.
• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter Cordeiro, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: September 1, 1998
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

US (1)