Breast Implant Clinical Studies

Breast Implant Shape and Size
Depending on the desired shape you wish to achieve, you and your surgeon may choose a round or contoured implant shape. Generally, the larger you want your cup size, the larger the breast implant the surgeon will consider (measured in cubic centimeters, or cc’s). You should be aware that contoured implants that are placed submuscularly (under your chest muscle) may assume a round shape after implantation.

Your surgeon will also evaluate your existing tissue to determine if you have enough to cover the breast implant. If you desire a breast implant size too large for your tissue, the surgeon may warn you that breast implant edges may be apparent or visible post-operatively. You may even risk surgical complications. Also, excessively large breast implants may speed up the effects of gravity and result in earlier droop or sag.

BREAST RECONSTRUCTION RESULTS FROM R95 STUDY
What Were The Complication Rates From The R95 Study?

The 3-year and 5-year complication rates are shown from the most common 5-year rate to the least common 5-year rate in the table below. The rates reflect the number of reconstruction patients out of 100 who experienced the listed complication at least once within the first 3 and 5 years after implantation. Some complications occurred more than once for some patients. The two most common complications experienced within the first 5 years of implantation were reoperation (45% or 45 patients out of 100) and asymmetry (39% or 39 patients out of 100).

Complication	N = 237 Patients
	3 - Year** Complications Rates	5 - Year Complication Rates
Additional Operation (Reoperation)	39%	45%
Asymmetry*	33%	39%
Capsular Contracture	25%	36%
Implant Replacement/Removal for Any Reason	23%	28%
Implant Palpability/Visibility*	20%	27%
Wrinkling*	23%	25%
Breast Pain*	15%	18%
Loss of Nipple Sensations*	12%	18%
Implant Malposition*	12%	17%
Leakage/Deflation	6%	8%
Irritation/Inflammation*	7%	7%
Intense Skin Sensation*	6%	6%
Scarring Complications	6%	6%
Infection	5%	6%
Capsule Calcification*	5%	5%
Seroma	4%	4%
Skin/Tissue Necrosis	4%	4%
Delayed Wound Healing*	3%	3%
Implant Extrusion	3%	3%
Skin Rash	3%	3%
Hematoma	1%	1%

*These Complications were assessed with severity ratings. Only the rates for moderate, severe, or very severe (excludes minld and very milde ratings) are shown in this table.
**As reported in original PMA submission

Reconstruction: What Were the Types of Additional Surgical Procedures Performed?

The following table provides a breakdown of the types of surgical procedures that were performed through 4 and 5 years after implantation. Through 5 years, there were 100 patients who had one or more additional operations after the initial implantation (reoperations), for a total of 126 reoperations. These 126 reoperations involved one or more surgical procedures, for a total of 159 surgical procedures. Examples of multiple procedures during a single reoperation include implant replacement for both breasts or a capsule procedure and mastopexy on the same breast. This table does not include the 282 planned nipple reconstruction and nipple/areolar tattoo procedures that occurred through 4 years. Only the 151 unplanned procedures through 4 years and the 159 unplanned procedures through 5 years are included in the table. The most common type of unplanned additional surgical procedure through 5 years was implant removal with replacement (31% of the 159 procedures performed).

Type of Surgical Procedures	N = 237 Patients
	Through 4 Years* % (N=151 Surgical Procedures)	Through 5 Years % (N=159 Surgical Procedures)
Implant Removal With Replacement**	30%	31%
Scar Revision/Wound Repair	18%	18%
Implant Removal Without Replacement	11%	13%
Capsule Procedure	12%	8%
Other Procedures***	7%	7%
Adjust Saline Fill Volume	6%	6%
Aspiration	5%	4%
Biopsy/Lump Removal	5%	4%
Reposition Implant	4%	4%
Nipple Related Procedures (unplanned)	2%	2%
Removal Skin Lesion/Cyst	1%	2%
Total	100%	100%

*As reported in original PMA submission.
**Some removals were replaced with a McGhan Medical implant, while others were replaced with a non-McGhan Medical implant.
***Through 4 years, other procedures were liposuction, revision of lateral left breast, excision of excess skin, placement of a stacked implant. Through 5 years, other procedures were liposuction, placement of a stacked implant, excision of excess skin, revise lateral left breast, Tram flap.