Breast Implant Clinical Studies

Reconstruction: What Were the Complication Rates After Implant Replacement?

There were 37 patients in the R95 Study who had 40 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 34% or 34 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 Large Simple Trial, LST.

Complication Following Replacement of Reconstruction Implant(s)	2-Year Complication Rate* % (N=40 Implants)	2-Year Complication Rate % (N=40 Implants Removed)
Capsular Contracture III/IV	33%	34%
Removal/Replacement	26%	27%
Leakage/Deflation	5%	10%
Infection	7%	3%

*As reported in original PMA submission with correction to capsular contracture rate.

Reconstruction: 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 R95 Study. Although there were 237 patients enrolled in the R95 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.

Reconstruction: What Were the Reasons for Implant Removal?

The following table details the primary reasons for implant removal in the R95 Study over the 5 years. Through 5 years, there were 70 devices removed in 62 patients. Of these 70 devices, 49 were replaced and 21 were not. The most common reason for implant removal through 5 years was capsular contracture (31% of the 70 implants removed).

Primary Reason for Implant Removal	Through 4 Years* % (N=62 Implants Removed)	Through 5 Years % (N=70 Implants Removed)
Capsular Contracture III/IV	26%	31%
Patient Request for Size/Style Change	23%	21%
Leakage/Deflation**	16%	17%
Infection	10%	10%
Wrinkling/Asymmetry/Malposition	11%	9%
Other***	8%	6%
Implant Extrusion	6%	6%
Total	100%	100%

*As reported in original PMA submission with additional data clarification.
**Includes removals where the reason for removal was unknown.
***Through 4 years, other reasons were recurrent breast cancer, abnormality of CT scan at mastectomy site, poor tissue expansion due to radiation, Ryan procedure. Through 5 years, other reasons were recurrent breast cancer abnormality of CT scan at mastectomy site, poor tissue expansion due to radiation, second stage breast reconstruction.

Reconstruction: What Were the Complication Rates After Implant Replacement?

There were 37 patients in the R95 Study who had 40 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 34% or 34 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 Large Simple Trial, LST.

Complication Following Replacement of Reconstruction Implant(s)	2-Year Complication Rate* % (N=40 Implants)	2-Year Complication Rate % (N=40 Implants Removed)
Capsular Contracture III/IV	33%	34%
Removal/Replacement	26%	27%
Leakage/Deflation	5%	10%
Infection	7%	3%

*As reported in original PMA submission with correction to capsular contracture rate.

Reconstruction: 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 R95 Study. Although there were 237 patients enrolled in the R95 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.