Breast Implant Clinical Studies

Breast Implant Augmentation: What Were the Complication Rates After Implant Replacement?

There were 78 patients in the A95 Study who had 126 implants removed and replaced with McGhan® implants. The table below reflects the number of replaced implants (not patients) out of 100 implants associated with the listed complications within 2 and 3 years following replacement. For example there was capsular contracture in 8% or 8 out of 100 implants at some time within 3 years after replacement. The complications reported following implant replacement were restricted to the same ones collected in the Larter Simple Trial, LST

Complication Following Replacement of Augmentation Implant(s)	2-Year Complications Rate % (N=108 Implants)	3-Year Complication Rate % (N=126 Implants)
Removal/Replacement	5%	18%
Leakage/Deflation	9%	9%
Capsule Contracture III/IV	7%	8%
Infection	1%	3%

*As reported in original PMA submission

Augmentation: What Were the Breast Disease and CTD Events?

Breast disease and connective tissue disease (CTD) were reported in some patients through 5 years after implantation in the A95 Study. Although there were 901 patients enrolled in the A95 Study, not every patient returned for each follow-up visit. Therefore, the percentage of patients with these events cannot be determined. Only the number of events can be reported. Without a comparison group of women with similar characteristics (such as age, race, etc.) and without breast implants, no conclusions can be made about the relationship between breast implants and these breast disease and CTD events.

There were 81 reports of breast disease through 5 years. Of these 81 reports, 7 are new since year 4. Additionally, 2 unknown outcome reports at year 4 were found to be false reports and were removed from the year 5 numbers, and the remaining 7 unknown outcome patients at year 4 were recategorized into benign. 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 5 Years*
Benign	66	80
Malignant	1	1
Unknown Outcome	7	0

*As reported in original PMA submission with additional data clarification:
Benign includes 22 additional reports and unknown outcome (includes 2 fewer 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 20 reports of CTD through 5 years. Of the 20 reports, 11 are new since year 4 (2 confirmed, 9 unconfirmed). Additionally, 3 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	2	0	3	0
Hyperthyroiditis	1	2**	2	1
Lupus Erythematosus and /or Rheumatoid Arthritis	0	3	0	1
Thyroiditis	0	2	0	4
Chronic Fatigue Syndrome or Fibromyalgia	2	0	2	4
Inflammatory Bowel Disease	0	0	0	1
Raynaud’s Phenomemon, graves’ Disease, Hyperthyroiditis, and Rheumatoid Arthritis	0	0	0	1**
Seronegative Spondylarthritis	0	0	0	1
TOTAL	5	7	7	13

*As reported in original PMA submission
**Patient was recategorized at 5 year timepoint

AUGMENTATION: WHATWERE THE BENEFITS?

The benefits of saline-filled breast implants in the A95 Study were assessed by a variety of outcomes, including bra cup size change, 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 bra size and satisfaction. Bra size was measured within the first year and a half after surgery. Satisfaction was measured at every follow-up visit through 5 years.