Allergan Clinical Studies

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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.) Allergan'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

Allergan 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, Allergan 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

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.

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: WHAT WERE 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.

859 of the original 901 patients (95%) at 18 months were included in an analysis of cup size (5% did not provide data because pre/post measurements were not obtained or replacement/removal occurred prior to obtaining a post measurement). Of these 859 patients, the following shows the percentage of patients experiencing various changes in cup size:

• Increase by 1 cup size: 38%
• Increase by 2 cup sizes: 49%
• Increase by 3 cup sizes: 9%
• No Increase: 4%

683 of the original 901 patients (76%) were included in an analysis of satisfaction at 5 years (24% were not included because satisfaction data was not obtained or implant replacement/removal occurred prior to 5 years). Of these 683 patients, 95% indicated being satisfied with their breast implants at 5 years.

Before implantation, augmentation patients scored higher (better) than the general U.S. female population on the SF-36 and MOS-20 scales, which measure general health-related quality of life. After 3 years, augmentation patients showed a worsening in their SF-36 and MOS-20 scores. The following two scales showed no change over the 3 years: The Tennessee Self Concept Scale (which measures overall self concept) and The Body Esteem Scale (which measures overall self esteem related specifically to one's body). The Rosenberg Self Esteem Scale (which measures overall self esteem) showed a slight improvement over the 3 years. The Semantic Differential Scale (which measures attitudes about your breasts compared to attitudes about yourself) showed that patients experienced an increased positive attitude towards their breasts compared to themselves.

BREAST AUGMENTATION CONSIDERATIONS

SPECIAL CONSIDERATIONS FOR BREAST AUGMENTATION
What Are the Alternatives to Breast Augmentation?

• Accept your breasts as they are
• Wear a padded bra or external prostheses

You are advised to wait a week after reviewing and considering this information before deciding whether to have augmentation surgery.

What Questions Should You Ask Your Surgeon About Breast Augmentation?

The following list of questions may help you to remind you of topics to discuss with your surgeon. You may have additional questions as well.
1. What are the risks and complications associated with having breast implants?
2. How many additional operations on my implanted breast(s) can I expect over my lifetime?
3. How will my breasts look if I decide to have the implants removed without replacement?
4. What shape, size, surface texturing, incision site, and placement site is recommended for me?
5. How will my ability to breast feed be affected?
6. How can I expect my implanted breasts to look over time?
7. How can I expect my implanted breasts to look after pregnancy? After breast feeding?
8. What are my options if I am dissatisfied with the cosmetic outcome of my implanted breasts?
9. What alternate procedures or products are available if I choose not to have breast implants?
10. Do you have before and after photos I can look at for each procedure and what results are reasonable for me?

Other Factors To Consider In Breast Augmentation
Choosing a Surgeon

When choosing an experienced surgeon who is experienced with breast implantation, you should know the answers to the following questions:
1. How many breast augmentation implantation procedures does he/she perform per year?
2. How many years has he/she performed breast implantation procedures?
3. Is he/she board certified, and if so, with which board?
4. In which province(s) is he/she licensed to practice surgery? Note that some sprovinces provide information on disciplinary action and malpractice claims/settlements to prospective patients either by request or on the world wide web.
5. What is the most common complication he/she encounters with breast implantation?
6. What is his/her reoperation rate with breast implantation and what is the most common type of reoperation he/she performs?

Familiarize yourself with the following options in breast implant surgery and be prepared to discuss with your surgeon the following issues:

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.

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.

There were 99 reports of breast disease through 5 years. Of these 99 reports, 7 are new since year 4. Additionally, 1 unknown outcome report was recategorzed at 5 years. 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 4 years*
Benign	72%	75%
Malignant	19%	24%
Unknown Outcome	1%	0%

** As reported in original PMA submission with additional data clarification:
Benign includes 61 additional 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 5 reports of CTD through 5 years. Of the 5 reports, 4 are new since year 4 (all unconfirmed). Additionally, 4 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	1	0	1	0
Lupus Erythematosus and/or Rheumatoid Arthritis	0	1	0	3
Inflammatory Bowel Disease	0	1	0	0
Thyroiditis	0	2	0	1
Total	1	4	1	4

*As reported in original PMA sumbission.

RECONSTRUCTION: WHATWERE THE BENEFITS?

The benefits of saline-filled breast implants in the R95 Study were assessed by a variety of outcomes, including 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 satisfaction which was measured at every follow-up visit through 5 years.

137 of the original 237 patients (58%) were included in an analysis of satisfaction at 5 years (42% were not included because satisfaction data was not obtained or implant replacement/removal occurred prior to 5 years). Of these 137 patients, 89% indicated being satisfied with their breast implants at 5 years.

Before implantation, reconstruction patients scored higher (better) than the general U.S. female population before implantation on some SF-36 scales, which measure general health-related quality of life. After 3 years, reconstruction patients showed an improvement in some of their SF-36 and MOS-20 scores. The following three scales showed no change over the 3 years: The Tennessee Self Concept Scale (which measures overall self concept), The Rosenberg Self Esteem Scale (which measures overall self esteem), and The Body Esteem Scale (which measures overall self esteem related specifically to one’s body). The Semantic Differential Scale (which measures attitudes about your breasts compared to attitudes about yourself) showed that patients experienced an increased positive attitude towards their breasts compared to themselves.

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