Breast Implant Clinical Studies

Breast Implants - What Were the Complication Rates from the A95 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 augmentation 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 (26% or 26 patients out of 100) and breast pain (17% or 17 patients out of 100).

Complication	N = 901 Patients
	3 - Year** Complications Rates	5 - Year Complication Rates
Additional Operation (Reoperation)	21%	26%
Breast Pain*	16%	17%
Wrinkling*	11%	14%
Asymmetry*	10%	12%
Implant palpability/Visibility*	9%	12%
Implant Replacement/Removal for Any Reason	8%	12%
Capsular Contracture	9%	11%
Intense Nipple Sensation*	9%	10%
Loss of Nipple Sensation*	8%	10%
Implant Malposition*	8%	9%
Intense Skin sensation*	7%	8%
Scarring Complications	6%	7%
Leakage/Deflation	5%	7%
Irritation/Inflammation*	3%	3%
Seroma	3%	3%
Hematoma	2%	2%
Skin Rash	2%	2%
Capsule Calcification*	1%	2%
Delayed Wound Healing	1%	1%
Infection	less than 1%	1%

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

Augmentation: 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 224 patients who had one or more additional operations after the initial implantation (reoperations), for a total of 293 reoperations. These reoperations involved one or more surgical procedures, for a total of 463 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. The most common type of additional surgical procedure through 5 years was implant removal with replacement (34% of the 463 procedures performed).

Type of Surgical Procedures	N=901 Patients
	Through 4 Years* % (N=402 Surgical procedures)	Through 5 Years % (N=463 Surgical procedures)
Implant Removal With Replacement**	30%	34%
Capsule Procedure	19%	19%
Adjust Saline fill Volume	11%	11%
Scar Revision/Wound Repain	8%	9%
Aspiration	7%	6%
Mastopexy	7%	6%
Biopsy/Lump Removal	4%	5%
Reposition Implant	5%	4%
Implant Removal Without Replacement	3%	2%
Removal of Skin Lesion/Cyst	2%	2%
Exploration of Breast area or Implants	2%	1%
Other Procedures***	2%	2%
Total	100%	100%

*As reported in original PMA submission with additional data clarification.
**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 laser treatment or chemical peel to correct color change of chest/breast, relaxing incisions, excision of excess skin, nipple related. Through 5 years, other procedures were laser treatment of chemical peel to correct color change of chest/breast area, relaxing incisions, excision of excess skin, revision plication of pocket, nipple related.

Augmentation: What Were the Reasons for Implant Removal?

The following table details the primary reasons for implant removal in the A95 Study over the 5 years. Through 5 years, there were 166 devices removed in 98 patients. Of these 166 devices, 156 were replaced and 10 were not. The most common reason for implant removal through 5 years was patient request for a size or style change (42% of the implants removed).

Primary Reason for Implant Removal	Through 4 Years* % (N=132 Implants Removed)	Through 5 Years* % (N=166 Implants Removed)
Patient Request for Size/Style Change	43%	42%
Leakage/Deflation	33%	33%
Capsular Contracture	10%	10%
Wrinkling/Asymmetry/Malposition	8%	5%
Implant Palpability/Visibility	0%	4%
Other***	2%	2%
Breast Pain	2%	2%
Infection	1%	1%
Implant Extrusion	1%	1%
Damage to Implant During Surgery	1%	1%
Total	100%	100%

*As reported in original PMA submission with additional data clarification.
**Includes 1 implant removal where the reason for removal is unknown Through 5 Years
*** Through 4 years, another reason was too much upper pole fullness. Through 5 years, other reasons were too much upper pole fullness and to be smaller/treat ptosis.