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INAMED - Making an Informed Decision
Saline-Filled Breast Implant Surgery

2004 Update

INTRODUCTION

TO THE PATIENT

The information contained in this booklet, Making an Informed Decision, Saline filled Breast Implant Surgery, is designed to provide you with an understanding of the risks and benefits of surgery with saline-filled breast implants, as well as provide an overview of the experience of patients in INAMED clinical studies.

Please review this information to ensure your preoperative consultation is effective and comprehensive. Make notes about issues that you would like to further discuss with your plastic surgeon, and ask questions. Give yourself time to consider your choices and proceed with surgery only after you are satisfied that the decision is right for you.

TO THE HEALTHCARE PROFESSIONAL

Discussion of the content of this document is an important part of the informed decision making process for the patient. Please take time to familiarize yourself with the information presented here and incorporate it into your pre-operative discussion.

For your convenience, a signature block is provided as a means of documenting the preoperative discussion in the patient’s file.

After removing the signature block, please give this book to the patient for her records.

Making an Informed Decision

Saline Filled Breast Implant surgery

I have reviewed the information presented in Making an Informed Decision, Saline Filled Breast Implant Surgery. My concerns and questions have been addressed by my doctor, and I have considered alternatives to surgery, including use of external prostheses.

I am choosing to proceed with saline-filled breast implant surgery.

Patient Name ____________________________________________

Patient Signature _________________________________________

Date ______________________________

Surgeon Name ____________________________________________

Surgeon Signature ________________________________________

Date ________________________________

TABLE OF CONTENTS

So You’re Considering Saline-Filled Breast Implant Surgery

What Gives the Breast Its Shape?
What is a Saline-Filled Breast Implant?
What are Important Factors for You to Consider When Deciding to Have Saline-Filled Implants?
Are You Eligible for Saline-Filled Breast Implants?
Who is not Eligible for Breast Implants?
What are Contraindications, Warnings, and Precautions for You to Consider?
What Types of Breast Implants Are Available from INAMED Aesthetics?

What are the Potential Breast Implant Complications?
INAMED’s Clinical Studies

Description of Studies
What Were the 1-Year Complication Rates from the LST?

Breast Augmentation Results from A95 Study

What Were the Follow-Up Rates from the A95 Study?
What Were the Complication Rates from the A95 Study?
What Were the Types of Additional Surgical Procedures Performed?
What Were the Reasons for Reoperation?
What Were the Reasons for Implant Removal?
What Were the Complication Rates After Implant Replacement?
What Were the Breast Disease and CTD Events?
What Were the Benefits?
Breast Augmentation Results from the PASS Study
What Were the Complication Rates from the PASS Study?
What Were the Reasons for Reoperation?
What Were the Reasons for Implant Removal?
What was the Satisfaction Rate at 7 Years?

Breast Augmentation Considerations

Special Considerations for Breast Augmentation
What Questions Should You Ask Your Surgeon About Breast Augmentation?
Other Factors to Consider in Breast Augmentation

Breast Reconstruction Results from R95 Study

What Were the Complication Rates from the R95 Study?
What Were the Types of Additional Surgical Procedures Performed?
What Were the Reasons for Reoperation?
What Were the Reasons for Implant Removal?
What Were the Complication Rates After Implant Replacement?
What Were the Breast Disease and CTD Events?
What Were the Benefits?
Breast Reconstruction Results from the PASS Study
What Were the Complication Rates from the PASS Study?
What Were the Reasons for Reoperation?
What Were the Reasons for Implant Removal?
What was the Satisfaction Rate at 7 Years

Breast Reconstruction Considerations

Special Considerations for Breast Reconstruction
What Questions Should You Ask Your Surgeon About Breast Reconstruction?
Other Factors to Consider in Breast Reconstruction

If You Experience a Problem, Should You Report It?
What Are Other Sources of Additional Information?
Glossary Of Medical Terms

WHAT GIVES THE BREAST ITS SHAPE?

The breast consists of milk ducts and glands, surrounded by fatty tissue that provides its shape and feel. Situated beneath the breast is the pectoralis major muscle (chest muscle) of the chest wall. Factors such as pregnancy (when milk glands are temporarily enlarged), rapid weight loss, and the effects of gravity as you age combine to stretch the skin, which may cause the breast to droop or sag.

WHAT IS A SALINE-FILLED BREAST IMPLANT?

A breast implant is a sac (implant shell) of silicone elastomer (rubber), which is surgically implanted under your tissues, and then filled with sterile saline, a salt water solution, through a valve.

WHAT ARE IMPORTANT FACTORS FOR YOU TO CONSIDER WHEN DECIDING TO HAVE SALINE-FILLED IMPLANTS?

• Whether you are undergoing augmentation or reconstruction, be aware that breast implantation may not be a one time surgery. You are likely to need additional surgery and surgeon visits over the course of your life.
• Breast implants are not considered lifetime devices. You will likely undergo implant removal with or without replacement over the course of your life.
• Many of the changes to your breast following implantation are irreversible (cannot be undone). If you later choose to have your implant(s) removed, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast.
• Breast implants may affect your ability to produce milk for breast feeding. Also, breast implants will not prevent your breast from sagging after pregnancy.
• With breast implants, routine screening mammography will be more difficult, and you will need to have additional views, which means more time and radiation.
• For patients who have undergone breast implantation either as a cosmetic or a reconstructive procedure, health insurance premiums may increase, coverage may be dropped, and/or future coverage may be denied. Treatment of complications may not be covered as well. You should check with your insurance company regarding these coverage issues.
  

ARE YOU ELIGIBLE FOR SALINE-FILLED BREAST IMPLANTS?

IMPLANTS ARE TO BE USED FOR FEMALES FOR THE FOLLOWING INDICATIONS (PROCEDURES):

BREAST AUGMENTATION
This is done to increase the size and proportion of a woman’s breasts. A woman must be at least 18 years old for breast augmentation.

BREAST RECONSTRUCTION
This procedure is done to restore a woman’s breast shape after a mastectomy or injury that resulted in either partial or total loss of the breast(s), or to correct a birth defect.

WHO IS NOT ELIGIBLE FOR BREAST IMPLANTS?

IMPLANTS ARE NOT TO BE USED FOR:

• Women with existing malignant or pre-malignant cancer of the breast without adequate treatment
• Women with an active infection anywhere in her body
• Augmentation in women who are currently pregnant or nursing

WHAT ARE CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS FOR YOU TO CONSIDER?

SURGICAL PRACTICES THAT ARE CONTRAINDICATED IN BREAST IMPLANTATION BECAUSE THEY MAY DAMAGE THE SHELL AND CAUSE DEFLATION/RUPTURE:

• Placement of drugs/substances inside the implant other than sterile saline
• Any contact of the implant with Povidone-Iodine
• Injection through the implant shell
• Alteration of the implant
• Stacking of implants (more than one implant per breast)
  

SAFETY AND EFFECTIVENESS HAS NOT BEEN ESTABLISHED IN PATIENTS WITH THE FOLLOWING CONDITIONS:

• Autoimmune diseases such as lupus and scleroderma
• Conditions that interfere with wound healing and blood clotting
• A weakened immune system (for example, currently receiving immunosuppressive therapy)
• Reduced blood supply to breast tissue

FURTHER CONSIDERATIONS:

Pre-implantation Mammography
You may wish to undergo a preoperative mammogram and another one 6 months to one year after implantation to establish a baseline.

Interference with Mammography
The implant may interfere with finding breast cancer during mammography and also may make it difficult to perform mammography. Therefore, it is essential that you tell your mammography technologist that you have an implant before the procedure. The technologist can use special techniques to minimize the possibility of rupture and to get the best possible views of the breast tissue. Because the breast is squeezed during mammography, it is possible for an implant to rupture during the procedure. More x-ray views are necessary with these special techniques; therefore, women with breast implants will receive more radiation. However, the benefit of the mammogram in finding cancer outweighs the risk of the additional x-rays.

Distinguishing the implant from breast tissue during breast self-examination
You should perform a breast self-examination monthly on your implanted breast. In order to do this effectively, you should ask your surgeon to help you distinguish the implant from your breast tissue. Any new lumps or an abnormal finding on the mammogram should be evaluated with a biopsy. If a biopsy is performed, care must be taken to avoid puncturing the implant.

Long Term Effects
The long term safety and effectiveness of breast implants have not been studied; however, INAMED is monitoring the long term (10 year) chance of implant rupture, reoperation, implant removal, and capsular contracture (hardening of the tissues around the implant). INAMED is also conducting mechanical testing to assess the long-term likelihood of implant rupture. As new information becomes available, INAMED will issue an updated version of this brochure.

Capsulotomy
You should be aware that closed capsulotomy, the practice of forcible squeezing or pressing on the fibrous capsule around the implant to break the scar capsule is not recommended as this may result in breakage of the implant.

WHAT TYPES OF SALINE-FILLED BREAST IMPLANTS ARE AVAILABLE FROM INAMED AESTHETICS?

Breast implants come in a variety of shapes, surface textures, and sizes. All currently available INAMED Aesthetics implants have a selfsealing (diaphragm) valve that is used for filling the device. Depending on the style, the filling valve may be located on the front (anterior) or the back (posterior) of the implant. Below is a description of INAMED Aesthetics breast implant styles. Be sure to familiarize yourself with the different features of breast implants and to discuss the most appropriate type(s) of implants for you with your surgeon.

A = Width; B = Projection Round Breast Implant	A = Width; B = Height; C= Projection Shaped Breast Implant

WHAT ARE THE POTENTIAL BREAST IMPLANT COMPLICATIONS?

Undergoing any surgical procedure may involve the risk of complications such as the effects of anesthesia, infection, swelling, redness, bleeding, and pain.

IN ADDITION, THERE ARE POTENTIAL COMPLICATIONS SPECIFIC TO BREAST IMPLANTS. THESE COMPLICATIONS INCLUDE:

Deflation/Rupture
Breast implants deflate when the saline solution leaks either through an unsealed or damaged valve or through a break in the implant shell. Implant deflation can occur immediately or slowly over a period of days and is noticed by loss of size or shape of your breast. Some implants deflate (or rupture) in the first few months after being implanted and some deflate after several years. Causes of deflation include damage by surgical instruments during surgery, overfilling or underfilling of the implant with saline solution, capsular contracture, closed capsulotomy, stresses such as trauma or intense physical manipulation, excessive compression during mammographic imaging, umbilical incision placement, and unknown/unexplained reasons. You should also be aware that the breast implant may wear out over time and deflate/rupture.

Deflated implants require additional surgery to remove and to possibly replace the implant.

Capsular Contracture
The scar tissue or capsule that normally forms around the implant may tighten and squeeze the implant and is called capsular contracture. Capsular contracture may be more common following infection, hematoma, and seroma. It is also more common with subglandular placement (behind the mammary gland and on top of the chest). Symptoms range from mild firmness and mild discomfort to severe pain, distorted shape, palpability of the implant, and/or movement of the implant.

Additional surgery is needed in cases where pain and/or firmness is severe. This surgery ranges from removal of the implant capsule tissue to removal and possibly replacement of the implant itself.

Capsular contracture may happen again after these additional surgeries.

Pain
Pain of varying intensity and duration may occur and persist following breast implant surgery. In addition, improper size, placement, surgical technique, or capsular contracture may result in pain associated with nerve entrapment or interference with muscle motion. You should tell your surgeon about severe pain.

Additional Surgeries
You should should know that there is a high chance that you will need to have additional surgery at some point to replace or remove the implant. Also, problems such as deflation, capsular contracture, infection, shifting, and calcium deposits can require removal of the implants. Many women decide to have the implants replaced, but some women do not. If you choose not to, you may have cosmetically unacceptable dimpling and/or puckering of the breast following removal of the implant.

Dissatisfaction with Cosmetic Results
Dissatisfying results such as wrinkling, asymmetry, implant displacement (shifting), incorrect size, unanticipated shape, implant palpability, scar deformity, hypertrophic (irregular, raised scar) scarring, and/or sloshing may occur. Careful surgical planning and technique can minimize but not always prevent such results.

Infection
Infection can occur with any surgery. Most infections resulting from surgery appear within a few days to weeks after the operation. However, infection is possible at any time after surgery. Infections with an implant present are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the implant may have to be removed, and another implant may be placed after the infection is resolved.

In rare instances, Toxic Shock Syndrome has been noted in women after breast implant surgery, and it is a life-threatening condition. Symptoms include sudden fever, vomiting, diarrhea, fainting, dizziness, and/or sunburn-like rash. A surgeon should be seen immediately for diagnosis and treatment for this condition.

Hematoma/Seroma
Hematoma is a collection of blood inside a body cavity, and a seroma is a collection of the watery portion of the blood (in this case, around the implant or around the incision). Postoperative hematoma and seroma may contribute to infection and/or capsular contracture. Swelling, pain, and bruising may result. If a hematoma occurs, it will usually be soon after surgery, however this can also occur at any time after injury to the breast. While the body absorbs small hematomas and seromas, large ones will require the placement of surgical drains for proper healing. A small scar can result from surgical draining. Implant deflation/rupture can occur from surgical draining if damage to the implant occurs during the draining procedure.

Changes in Nipple and Breast Sensation
Feeling in the nipple and breast can increase or decrease after implant surgery. The range of changes varies from intense sensitivity to no feeling in the nipple or breast following surgery. Changes in feeling can be temporary or permanent and may affect your sexual response or your ability to nurse a baby. (See the paragraph on breast-feeding below.)

Breast Feeding
At this time it is not known if a small amount of silicone may diffuse (pass through) from the saline-filled breast implant silicone shell and may find its way into breast milk. If this occurs, it is not known what effect it may have on the nursing infant. Although there are no current methods for detecting silicone levels in breast milk, a study measuring silicon (one component in silicone) levels did not indicate higher levels in breast milk from women with silicone–filled gel implants when compared to women without implants.

With respect to the ability to successfully breast feed after breast implantation, one study reported up to 64% of women with implants who were unable to breast feed compared to 7% without implants. The periareolar incision site may significantly reduce the ability to successfully breast feed.

Calcium Deposits in the Tissue Around the Implant
Deposits of calcium can be seen on mammograms and can be mistaken for possible cancer, resulting in additional surgery for biopsy and/or removal of the implant to distinguish the calcium deposits from cancer.

Delayed Wound Healing
In some cases, the incision site takes longer to heal than normally.

Extrusion
Unstable or compromised tissue covering and/or interruption of wound healing may result in extrusion, which is when the breast implant comes through the skin.

Necrosis
Necrosis is the formation of dead tissue around the implant. This may prevent wound healing and require surgical correction and/or implant removal. Permanent scar deformity may occur following necrosis. Factors associated with increased necrosis include infection, use of steroids in the surgical pocket, smoking, chemotherapy/radiation, and excessive heat or cold therapy.

Breast Tissue Atrophy/Chest Wall Deformity
The pressure of the breast implant may cause the breast tissue to thin and shrink. This can occur while implants are still in place or following implant removal without replacement.

In addition to these complications, there have been concerns with certain systemic diseases, of which you should be aware:

Connective Tissue Disease
Concern over the association of breast implants to the development of autoimmune or connective tissue diseases, such as lupus, scleroderma, or rheumatoid arthritis, was raised because of cases reported in the literature with small numbers of women with implants. A review of several large epidemiological studies of women with and without implants indicates that these diseases are no more common in women with implants than those in women without implants. However, a lot of women with breast implants believe that their implants caused a connective tissue disease.

Cancer
Published studies indicate that breast cancer is no more common in women with implants than those without implants.

Second Generation Effects
There have been concerns raised regarding potential damaging effects on children born of mothers with implants. A review of the published literature on this issue suggests that the information is insufficient to draw definitive conclusions.

INAMED’S 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 Inamed saline-filled breast implants. 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 7 years is 3 in 10 for augmentation patients and about 1 in 2 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 Post Approval Survey Study (PASS)

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.

The A95/R95 sections of the brochure include 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 Post Approval Survey Study was designed to collect long-term safety data from A95/R95 patients from 6-10 years post-implant. The data are collected from surveys that are mailed out to the patients each year. The PASS Study data are shown within both the Reconstruction and Augmentation Sections following the A95/R95 data. The data presented through 7 years includes earlier data shown in the tables with new information added to it.

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.

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

BREAST AUGMENTATION RESULTS FROM A95 STUDY

AUGMENTATION: WHAT WERE THE FOLLOW-UP RATES FROM THE 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).

Note: *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).

* As reported in orginal PMA submission with additional data clarification.
** Some removals were replaced with an Inamed implant, while others were replaced with a non-Inamed implant.

AUGMENTATION: WHAT WERE THE REASONS FOR REOPERATION?

The reasons for reoperation through 4 and 5 years are shown below. The reasons for reoperation may overlap with the types of surgical procedures performed, but they are two different sets of data. An example of a type of additional surgical procedure is repositioning of an implant; an example of a reason for reoperation is implant malposition.

There were 257 reoperations performed in 204 patients through 4 years. There were 293 reoperations performed on 225 patients through 5 years. The most common reason for reoperation through 5 years was deflation (18% of the 293 reoperations).

*Total is greater than 100% because some reoperations were performed for multiple reasons.

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).

* As reported in original PMA submission with additional data clarification.
** Includes 1 implant removal where the reason for removal is unknown.

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 Inamed 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 Large Simple Trial, LST (refer to page 16).

* 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.

* 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.

* 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 over the 3 years.

BREAST AUGMENTATION RESULTS FROM POST APPROVAL SURVEY STUDY (PASS)

The section above summarizes the data collected through 5 years. This section focuses on the augmentation data collected through the PASS, which involved mail-in surveys. The following tables present results through 7 years. Of the women expected to return completed surveys for the 7-year post-implantation study interval, data were collected for 85% of the augmentation patients.

AUGMENTATION: WHAT WERE THE COMPLICATION RATES FROM THE PASS STUDY?

The 7-year complication rates are shown from the most common to the least common. The rates reflect the number of augmentation patients out of 100 who experienced the listed complication at least once within the first 7 years after implantation. The most common complication experienced through 7 years was reoperation (30%, 30 out of every 100 patients).

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

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?

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 states is he/she licensed to practice surgery? Note that some states 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.

SURFACE TEXTURING
Textured surface implants were designed to reduce the chance of capsular contracture. Some information in the literature with small numbers of patients suggests that surface texturing reduces the chance of severe capsular contracture, but clinical information from studies of a large number of women with INAMED implants shows no difference in the likelihood of developing capsular contracture with textured implants compared to smooth surfaced implants.

PALPABILITY
The following may cause implants to be more palpable (more easily felt): textured implants, larger implants, subglandular placement, and the amount of skin/tissue available to cover the implant.

IMPLANT PLACEMENT
The breast implant can be placed either partially under the pectoralis major muscle (submuscular) or on top of the muscle and under the breast glands (subglandular) depending on the thickness of your breast tissue and its ability to adequately cover the breast implant. You should discuss with your surgeon the pros and cons of the implant placement selected for you.

Breast before augmentation	Breast after subglandular augmentation	Breast after submuscular augmentation

The submuscular placement may make surgery last longer, may make recovery longer, may be more painful, and may make it more difficult to have some reoperation procedures than the subglandular placement. The possible benefits of this placement are that it may result in less palpable implants, less capsular contracture, and easier imaging of the breast with mammography.

The subglandular placement may make surgery and recovery shorter, may be less painful, and may be easier to access for reoperation than the submuscular placement. However, this placement may result in more palpable implants, more capsular contracture, and more difficult imaging of the breast with mammography.

INCISION SITES

To permit the smallest possible incision, the implant is typically inserted empty, and then filled with saline. You should discuss with your surgeon, the pros and cons for the incision site specifically recommended for you.

There are three common incision sites: under the arm (axillary), around the nipple (periareolar), or within the breast fold (inframammary). If the incision is made under the arm, the surgeon may use a probe fitted with a miniature camera, along with minimally invasive (very small) instruments, to create a "pocket" for the breast implant.

Periareolar
This incision is most concealed, but is associated with a higher likelihood of inability to successfully breast feed, as compared to the other incision sites.

Inframammary
This incision is less concealed than periareolar and associated with less difficulty than the periareolar incision site when breast feeding.

Axillary
This incision is less concealed than periareolar and associated with less difficulty than the periareolar incision site when breast feeding.

Umbilical/endoscopic
This incision site has not been studied and is not recommended.

SURGICAL SETTING AND ANESTHESIA
Augmentation surgery is usually performed on an outpatient basis, either in a hospital operating room, surgery center, or surgical suite in the surgeon's office. General anesthesia is commonly used, and local anesthesia is also an option. The surgery usually lasts one to two hours. Your surgeon will make an incision and create a pocket for the breast implant. Then, the breast implant will be placed in the pocket, filled, and positioned. Finally, the incision will be closed, usually with stitches, and possibly taped.

POST-OPERATIVE CARE
You will probably feel somewhat tired and sore for several days following the operation, and your breasts may remain swollen and sensitive to physical contact for a month or longer. You may also experience a feeling of tightness in the breast area as your skin adjusts to your new breast size.

Post-operative care may involve the use of a post-operative bra, compression bandage, or jog bra for extra support and positioning while you heal. At your surgeon's recommendation, you will most likely be able to return to work within a few days, although you should avoid any strenuous activities that could raise your pulse and blood pressure for at least a couple of weeks. Your surgeon may also recommend breast massage exercises.

Note: If you experience fever, or noticeable swelling and/or redness in your implanted breast(s), you should contact your surgeon immediately.

INSURANCE
Insurance does not cover breast augmentation and may not cover reoperation (additional surgery) and additional surgeon's visits following augmentation.

BREAST RECONSTRUCTION RESULTS FROM R95 STUDY

RECONSTRUCTION: WHAT WERE THE FOLLOW-UP RATES FROM THE R95 STUDY?

The R95 Study enrolled 237 reconstruction patients, with 71% returning for their 3-year follow-up visit. Of those R95 patients expected to be seen for their 5-year follow-up visit, 80% returned and were evaluated.

RECONSTRUCTION: 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).

Note:
* 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.

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).

* As reported in original PMA submission with additional data clarification.
** Some removals were replaced with an Inamed implant, while others were replaced with a non-Inamed implant.
*** Through 4 years, other procedures were liposuction, placement of a stacked implant.
Through 5 years, other procedures were liposuction, placement of a stacked implant.

RECONSTRUCTION: WHAT WERE THE REASONS FOR REOPERATION?

The reasons for reoperation through 5 years are shown below. The reasons for reoperation may overlap with the types of surgical procedures performed, but they are two different sets of data. An example of a type of additional surgical procedure is repositioning of an implant; an example of a reason for reoperation is implant malposition.

There were 117 reoperations performed in 94 patients through 4 years. There were 125 reoperations performed in 99 patients through 5 years. The most common reason for reoperation through 5 years was capsular contracture (27% of the 125 reoperations).