Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
---|---|
Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00582153 |
This study willbe used to collect short-term (5 year) data about possible health problems associated with silicone gel implants. This data will be used to help see if the implants are both safe and effective.
Condition |
---|
Breast Reconstruction |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Adjunct Study Protocol For Mentor H/S Silicone Gel-Filled Mammary Prostheses |
Estimated Enrollment: | 250 |
Study Start Date: | April 1998 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Breast implants have been used in nearly two million women for nearly 30 years. Although there are side effects and risks of having silicone breast implants, most women who have received them have had satisfactory results. Silicone gel breast implants are optional. They are used because they offer more normal breast consistency to palpation and minimize the possibility of ripple formation typically seen with saline breast implants. The advantage of silicone gel implants over saline implants is purely cosmetic. There are no health benefits to using silicone gel implants. All implants no matter what type require replacement eventually. The Food andDrug Administration (FDA) is concerned that we do not know enough about possible health problems from the silicone gel implants. The FDA has called for detailed studies and has allowed silicone gel implants to be used in these studies while the data is being collected. This study will be used to collect short-term (5 year) data about possible health problems associated with silicone gel implants. This data will be used to help see if the implants are both safe and effective.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Females who are candidates for breast reconstruction
Inclusion Criteria:
The patient must have at least one of the following breast conditions:
revision or replacement required for patients whose prior surgery was not the result of treatment for cancer and for whom saline implants are unsuitable (e.g.
skin too thin, insufficient tissue, etc.) as deemed by the surgeon.
Exclusion Criteria:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Peter Cordeiro, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Peter Cordeiro, MD ) |
Study ID Numbers: | 98-027 |
Study First Received: | December 21, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00582153 |
Health Authority: | United States: Food and Drug Administration |
Breast Cancer Implants Reconstruction |