Breast Implant Clinical Studies

Breast Implant INAMED Clinical Studies

Although you will experience your own risks (complications) and benefits following breast implant surgery, this section describes the specific complications and benefits of McGhan® saline-filled breast implants. (For complete information on the complications associated with Saline Filled Breast Implant surgery click here.) INAMED's studies indicate, for example, that most women can expect to experience at least one complication at some point through 5 years after implant surgery. The studies also indicate that the chance of additional surgery through 5 years is about 1 in 4 for augmentation patients and 1 in 2.5 for reconstruction patients. The information below provides more details about the complications and benefits you may experience.

Description of Studies

INAMED conducted clinical studies testing of its saline-filled breast implants to determine the short-term and most common complications as well as benefits of their implants. These were assessed in the following studies:

• The Large Simple Trial (LST)
• The 1995 Augmentation Study (A95)
• The 1995 Reconstruction Study (R95)

The Large Simple Trial was designed to determine the 1-year rates of capsular contracture, infection, implant leakage/deflation, and implant replacement/removal. There were 2,333 patients enrolled for augmentation, 225 for reconstruction, and 317 for revision (replacement of existing implants). Of these enrolled patients, 62% returned for their 1-year follow-up visit.

The A95 and R95 Studies were designed as 5-year studies to assess all complications as well as patient satisfaction, body image, body esteem, and self concept. Patients were followed annually and data through 3 years (with partial 4 year data) were presented to FDA for PMA approval. After PMA approval, INAMED transitioned data collection to a post-approval study. The first phase of this postapproval study consisted of completion of the A95 and R95 Studies, with collection of all risk/benefit information through 5 years.

This section of the brochure includes original data presented to FDA for PMA approval along with the 5-year post-approval study data. The data presented through 5 years includes earlier data shown in the tables with new information added to it.

The A95 Study enrolled 901 augmentation patients, with 77% returning for their 3-year follow-up visit. Of those A95 patients available to be seen for their 5-year follow-up visit, 81% returned and were seen at 5 years after implant surgery. The R95 Study enrolled 237 reconstruction patients, with 71% returning for their 3-year follow-up 10 visit. Of those R95 patients available to be seen for their 5-year follow up visit, 80% returned and were seen at 5 years after implant surgery.

What Were the 1-Year Complication Rates from the LST?

The table below shows the complication rates for augmentation, reconstruction, and revision patients through 1 year. The rates reflect the number of patients out of 100 who experienced the listed complication. For example, 7% or 7 out of 100 augmentation patients experienced capsular contracture at some time within 1 year after implantation. However, this does not mean that 7% of patients still have capsular contracture at 1 year.

Complication	1-Year Complication Rate
	Augmentation	Reconstruction	Revision
Capsular Contracture III/IV	7%	13%	12%
Implant Removal	6%	14%	8%
Leakage/Deflation	4%	3%	5%
Infection	2%	6%	3%

*Data on 62% of the 2875 patients enrolled in the study

Breast Augmentation Results from A95 Study