Breast Implant Clinical Studies

Breast implants continued:

There were 99 reports of breast disease through 5 years. Of these 99 reports, 7 are new since year 4. Additionally, 1 unknown outcome report was recategorzed at 5 years. The reports of breast disease through 4 and 5 years are summarized in the following table.

Breast Disease Observation	No. of Patient Reports Through 4 years*	No. of Patient Reports Through 4 years*
Benign	72%	75%
Malignant	19%	24%
Unknown Outcome	1%	0%

** As reported in original PMA submission with additional data clarification:
Benign includes 61 additional reports.

The table below shows the number of patients reported to have CTD through 4 and 5 years after implantation. Confirmed reports were based on a diagnosis by a doctor. Unconfirmed reports were based on self-reports by the patients. There were 5 reports of CTD through 5 years. Of the 5 reports, 4 are new since year 4 (all unconfirmed). Additionally, 4 unconfirmed reports at year 4 were found to be false reports and were removed from the year 5 numbers.

Connective Tissue Disease	Through 4 Years*		Through 5 Years
	No of confirmed Reports	No. of Unconfirmed Reports	No of confirmed Reports	No. of Unconfirmed Reports
Graves' Disease	1	0	1	0
Lupus Erythematosus and/or Rheumatoid Arthritis	0	1	0	3
Inflammatory Bowel Disease	0	1	0	0
Thyroiditis	0	2	0	1
Total	1	4	1	4

*As reported in original PMA sumbission.

RECONSTRUCTION: WHATWERE THE BENEFITS?

The benefits of saline-filled breast implants in the R95 Study were assessed by a variety of outcomes, including patient satisfaction, body image, body esteem, and self concept. These outcomes were assessed for patients with both original and replacement saline devices before implantation and at 3 years after surgery, except for satisfaction which was measured at every follow-up visit through 5 years.

137 of the original 237 patients (58%) were included in an analysis of satisfaction at 5 years (42% were not included because satisfaction data was not obtained or implant replacement/removal occurred prior to 5 years). Of these 137 patients, 89% indicated being satisfied with their breast implants at 5 years.

Before implantation, reconstruction patients scored higher (better) than the general U.S. female population before implantation on some SF-36 scales, which measure general health-related quality of life. After 3 years, reconstruction patients showed an improvement in some of their SF-36 and MOS-20 scores. The following three scales showed no change over the 3 years: The Tennessee Self Concept Scale (which measures overall self concept), The Rosenberg Self Esteem Scale (which measures overall self esteem), and The Body Esteem Scale (which measures overall self esteem related specifically to one’s body). The Semantic Differential Scale (which measures attitudes about your breasts compared to attitudes about yourself) showed that patients experienced an increased positive attitude towards their breasts compared to themselves.