The Best Breast 2

Introduction

“It’s normal to want to feel normal. It’s also normal to want to be the best you can be.”

A New World for Breast Augmentation Patients

Out to Dinner the Evening of Surgery, Full Normal Activities within Twenty-four Hours

In just six years since the first edition of The Best Breast, the world of breast augmentation has changed more than it changed in the previous three decades. A new world of breast augmentation is now available for patients—a redefined patient experience that enables most patients to go out to dinner the evening of surgery and return to full, normal activities within twenty-four hours.

Routine 24-Hour Return to Normal Activities Following Breast Augmentation

Today, our patients routinely (with 96 percent predictability) return to full, normal activities within twenty-four hours following their breast augmentation,¹ raising their arms fully above their heads, lying on their breasts, driving their cars, lifting normal objects and small children, and immediately resuming their normal daily activities. More than 80 percent of our augmentation patients are out to dinner the evening of surgery with no drain tubes, no narcotic pain medications, no bandages, no special bras, and no pain pumps.

Many surgeons today consider this type of patient recovery and patient experience totally impossible, but patients can expect to see more and more surgeons delivering this level of care to patients as surgeons attend our educational venues and read and apply information from the peer-reviewed scientific articles we have published during the past decade^{1,2,3,4,5,6,7,8,9,10,11,12,13} in the most respected journal in plastic surgery.

Every Major area of breast augmentation redefined for Patients and surgeons

Beginning a decade ago, we set a goal to redefine every aspect of breast augmentation—to dramatically and conclusively change the patient and surgeon experience. That goal is now reality. Seven years of clinical research have produced patient education, surgical planning, implant selection, and surgical techniques that redefine the patient experience in breast augmentation:

• New patient choice, patient education, and informed consent systems provide you with more information and help you make more informed decisions than ever before.⁹ You can make more informed choices based on more thorough, complete information.
• This is the first system in history that bases implant selection on your personal, individual tissue characteristics with the goal of reducing long-term risks, complications, and reoperations. The TEPID™ system⁸ and the latest High Five™¹² system are completely unique, new systems that replace our previously published dimensional system and enable surgeons to tailor breast implant selection to individual patients’ tissue characteristics, eliminating many previous unrealistic and unpredictable selection methods such as stuffing materials into bras or relying on pictures to define choices. Bra-stuffing and pictures never match your individual patient tissue characteristics and cannot optimally evaluate the two most critical factors in assessing optimal implant size—the width of your breast and the amount your tissues stretch.
• A new decision and operative planning system, the High Five™ system¹², defines the five most critical decisions in augmentation and uses five simple measurements to allow surgeons and patients to base decisions on individual patient tissue characteristics. This new system enables surgeons to make more important decisions before you are asleep in the operating room, shortening the time you are under anesthesia, reducing the amounts of drugs that are administered, reducing your time to awaken and leave a surgery center, reducing nausea and vomiting, and speeding your overall recovery.
• New Dual-Plane⁶ techniques no longer require patients to choose between placing the implant either under or over muscle; instead, they combine the two pocket locations. A dual-plane pocket for the implant combines a submuscular pocket above that transitions to a submammary pocket in the lower breast, enabling surgeons to maximize the benefits of both locations while minimizing the trade-offs of each previous pocket location.
• New 24-Hour Recovery^1,2 surgical techniques and instruments dramatically reduce bleeding and surgical trauma to your tissues during surgery, enabling an almost unbelievably rapid recovery with minimal pain for most patients. More than 80 percent of our patients are out to dinner the evening of surgery, and 96 percent return to full, normal activities within twenty-four hours.² These techniques can be applied through any of three different incision approaches that you choose, and the techniques are now being learned and applied by surgeons worldwide.
• The largest body of peer-reviewed and published scientific data in history about full-height, anatomically shaped implants (the Inamed-Allergan Style 468 full height, textured, anatomic saline implant and now in FDA studies, the Style 410 cohesive, form stable gel implant), which are now available in form-stable silicone gel and saline filled versions in a matrix of sizes and shapes. Peer-reviewed data published in the most respected professional journal in plastic surgery and further validated by our data in FDA studies of the new implants confirm information that we published in the first edition of The Best Breast:
  • Adequate implant fill in an anatomically shaped implant device may significantly reduce deflation rates and reoperation rates due to visible wrinkling and rippling.³
  • Malposition risks with a full-height anatomic implant are minimal (only three reoperations for malposition in over 1,600 cases [0.2 percent] in our published studies).^2,5,6 When these implants are used optimally by surgeons with optimal training, risks of malposition are lower than malposition risks for round implants in FDA PMA studies.^14,15
  • When used with optimal patient tissue selection criteria and surgical techniques, textured anatomic implants have as low or a lower rate of visible wrinkling or rippling compared to round, smooth shell implants (0 percent in our 1,662 cases^2,5,6 using anatomic implants compared to 15.5 percent in averaged FDA study data of round implants).^14,15
• Recently completed FDA clinical studies show the newest, most advanced technology likely to reach patients in the United States is the form-stable cohesive gel, anatomic implant (Allergan Inamed Style 410). The impressive five-year results with this product in FDA clinical studies in the United States reinforce the extensive experience of surgeons in Europe and Asia with the Inamed Style 410 implant over the past thirteen years. Most impressively, and for the first time in the history of FDA studies of breast implants, the style 410 had a zero percent device failure rate at two years in all first-time augmentation patients enrolled in the FDA study.¹⁶
• An unprecedented opportunity for dramatically lower reoperation rates following breast augmentation can be realized by using processes that we have defined and published in the November 2006 issue of Plastic and Reconstructive Surgery Journal, the most respected professional journal in plastic surgery. For the first time in the history of FDA studies on breast implants in the United States, we were able to document a 0 percent reoperation rate at three-year follow-up in a series of fifty consecutive patients enrolled in an independently supervised and monitored FDA study of the Allergan/Inamed Style 410 form-stable, cohesive-silicone-gel implant.¹³ The systems, processes, and implant devices that we defined in this publication offer surgeons worldwide an opportunity to apply these processes to dramatically lower reoperation rates compared to average 15 to 20 percent reoperation rates in previous FDA studies.^14,15,17

These dramatic improvements in breast augmentation offer patients choices and opportunities that are unprecedented in the history of breast augmentation. Motivated surgeons worldwide are now offering patients the benefits of the processes, methods, and techniques that we have developed over the past decade.

In order to take advantage of these advancements, patients must be willing to become educated about all of the options and trade-offs in breast augmentation. Optimal decisions require knowledge. A surgeon can provide information and assist with decisions, but every patient must assume responsibility for her choices and requests. The more educated the patient, the better her choices and decisions and the better her chances of achieving the best breast.

The best breast is the natural female breast—until nature misses a beat or takes a toll, or a woman decides that it’s not.

It’s normal to want to feel normal. It’s also normal to want to be the best that you can be.

What Is Normal? What Is Best?

What is normal? If you asked a hundred women, you might get one hundred different answers. What is normal is personal to each individual—something that’s most important to that person alone. Wanting to feel normal and be the best you can be are human traits that motivate and reward on a very personal level.

Every woman’s breasts are special. Special in ways that may differ among women, but special in a personal way to each woman. Breasts change significantly during a woman’s lifetime. During adolescence, the breasts usually enlarge. With pregnancy, the breasts enlarge, cycle during nursing, become smaller after pregnancy, and change in shape. Aging also changes the shape and position of a woman’s breasts (Figure 1-1). A woman’s breasts never match. Enlargement during puberty and pregnancy is not predictable, and the effects of pregnancy on the breast can vary widely. A woman’s tissue characteristics and the size of her breasts affect changes in the appearance of her breasts as she ages.

A woman may view her breasts differently at different times in her life, so the best breast at one time may not necessarily be the best breast at another time. In this book, we define the best breast for any woman as a personal decision, defined by that one woman’s personal feelings, wishes, her tissues, and what her body will allow her to have (Figure 1-2). In this book, we will help you understand the choices available for breast augmentation, provide facts about those choices, and guide you in your decision-making process.

The best breast is the natural female breast—until nature misses a beat or takes a toll, or a woman decides that it’s not (Figures 1-1, 1-2, 1-3). The only totally natural breast is a totally natural breast. An augmented breast is not totally natural, and you should not expect it to be. If you want a totally natural breast, you should probably not have a breast augmentation. On the other hand, if the benefits out-weigh the trade-offs, and the risks of breast augmentation are acceptable to you, augmentation provides options that can improve what you otherwise can’t improve or restore what you otherwise can’t restore.

Practical Anatomy of the Breast

The basic components of the breast are
1) a skin envelope, and 2) breast tissue filler (parenchyma).

In simple terms, the breast consists of a skin envelope that surrounds and contains the breast tissue. The breast tissue lies on top of the pectoralis muscle. Beneath the muscle layer are the ribs that form the chest wall (Figure 1-4).

The skin envelope is the main support of the breast. Attachments are present between the back of the breast tissue and the front of the muscle, but these attachments don’t contribute significant support to the breast. The larger the breast, with or without pregnancy and with or without an implant, the more gravity pulls downward on the breast tissue, stretching the lower skin envelope and allowing the breast to sag.

Following augmentation, the components of the breast are
1) the skin envelope, 2) the breast tissue, and 3) the implant.

Women Who Consider Augmentation

Three groups of women frequently consider breast augmentation:

Abnormal Development During Puberty: when Nature Misses a Beat

When breast development is inadequate during puberty, the breasts are disproportionately small compared to the rest of a woman’s figure (Figure 1-5). Some women refer to this disproportion as a “bowling pin” figure, with the hips and lower body appearing wider than the narrower upper body. Buying clothing can be difficult. If it fits the bottom, it doesn’t fit the top. Pushing up what you have is an option, provided you have enough to push up. Fillers are also an option, but a constant nuisance, and the balance provided by pushing up or fillers disappears when clothing is removed. Fillers and enhancers never feel like they belong to you. They never become a natural part of your body image.

Inadequate breast development during puberty produces breasts that don’t appear normal.

The abnormal appearance can be a deformity or an
imbalance with the rest of a woman’s figure.

If the breasts develop abnormally during puberty, the shape of the breast can be abnormal (Figure 1-6) and can affect how a woman feels about herself. No woman has two breasts that are the same, but sometimes the normal amount of variation in breast shape and size is too much (significant asymmetry). Imagine the difficulty when you are trying to buy clothing and dressing to feel normal and how you might feel when clothing is removed.

The patient in Figure 1-6 illustrates an important point—that while routine breast augmentation enlarges and improves the breast, the procedure does not dramatically relocate the nipple-areola complexes. The down-pointing and outward-pointing configuration of this patient’s nipples were not a major concern to her, and prior to her augmentation, she elected not to have the incisions and scars around her areolas that would be required to relocate them or risk sensory changes. By making these choices, the patient minimized possible trade-offs of nipple relocation while maximizing the benefits of breast augmentation. Each individual patient must make personal decisions about priorities and trade-offs before surgery.

Changes Following Pregnancy

Hundreds of women who consult us for breast augmentation following pregnancy have said, “I had no idea what pregnancy and nursing would do to my breasts. Not that it isn’t worth it, I just had no idea. I loved it when they were full, but now they’re saggy and almost gone!” The effects of pregnancy and nursing on the breast are variable but usually predictable. During pregnancy, tissue inside the breast enlarges and the skin envelope stretches. As the skin stretches, usually more in the lower breast, the larger, heavier breast is pulled downward by gravity, regardless of how much it is supported by a bra. During nursing, the breast cycles up and down, stretching the skin repeatedly. Following pregnancy and nursing, the tissue inside the breast (the breast parenchyma) usually decreases substantially in size, often to a size less than before the pregnancy, but the skin almost never shrinks back to its original size.

A stretched and enlarged skin envelope with less breast
tissue to fill it is common following pregnancy.

The result is an empty upper breast and a sagging
appearance in the lower breast.

More skin with less filler is typical following pregnancy and nursing. The stretched skin envelope with insufficient tissue to fill it produces predictable changes in breast appearance. The breast tissue filler predictably falls to the bottom of the envelope, leaving the upper breast appearing empty. Most women describe the empty upper breast and fuller lower breast as “saggy.” Many women who consult us for augmentation following pregnancy ask for more fill in the upper breast to help restore a breast form closer to the breast they had before pregnancy.

Women Who Want to Improve Appearance of Their
Breasts

The third group of women who seek augmentation usually want to improve the shape and/or size of their breasts for a variety of personal reasons. These are normal women who want to feel better, who want to be the best they can be. Some developed very unattractive breasts during puberty. Others have so much variation between the breasts that they have difficulty with clothing options. Still others want to improve the balance between the upper and lower portions of their body. Each woman’s reasons are personal. Every woman has the right to want to optimize any aspect of her appearance.

The Importance of Realistic Expectations

Your expectations for augmentation must be realistic for you to be happy with the results.

The goal of augmentation is to improve the size and shape of your breasts. To the extent that the results meet your goals, you can have a more positive self-image, and these feelings may allow you to project a more open, positive image to others. But the only predictable change is larger breasts. This is an operation on the breasts, not on the brain. Positive psychological effects are common, but are not necessarily predictable. Certainly, your breast augmentation cannot be expected to have any predictable effect on other people. Some will notice, some may not—depending on your choices of clothing and breast exposure. Your love life may improve, but it may not. The breasts are only one of the many factors that affect the quality of one’s love life! A better figure doesn’t necessarily guarantee a model more modeling jobs or an actress more roles. The decision to have a breast augmentation should be based on realistic, personal objectives that you discuss with your surgeon.

Your surgeon can only work with what you bring—your tissues and your expectations.

The better you communicate with your surgeon, the more thoroughly your surgeon presents your options. The more expertly your surgeon executes your choices, the more rapid your recovery will be and the more likely you will have a result that pleases both of you.

The Importance of Information and Knowledge

A patient motivated us to write this book with the following challenge, “Knowing everything that twenty-nine years of experience has taught you, help me and other patients with the tough questions we all face. To make the best decisions about augmentation, what do I need to know, how do I go about learning it, and what is the logical sequence of making informed decisions? Walk me step-by-step through a thorough, logical approach to making good decisions about breast augmentation.”

Based on our experience in treating thousands of breast augmentation patients over the past twenty-nine years, we are convinced that patients need more information to guide them through the research and decision-making process when considering this operation. You can’t be helped by what you don’t know. The more you know, both good and bad, the more realistically you can evaluate your options, the more equipped you are to deal with surgeons and the surgical experience, and the more likely you are to enjoy the benefits and minimize the risks and trade-offs of augmentation.

Knowledge Is the Basis of a Logical Approach to Good Decision-Making.

Based on our experience with patients, we believe in a simple premise. The more you know, the better you can make informed decisions. The more thoroughly you research and understand your options, the better your decisions. The better your decisions, the more likely you are to achieve your goals with minimal risks and trade-offs. The better you communicate your desires and questions to your surgeon, the more likely you’ll make good team decisions. Knowledge, common sense, and communication skills are important.

How This Book Is Organized and Formatted

We have organized this book for flexibility. For the most complete information in the most logical sequence, read from beginning to end. If you want an overview without details, read the emphasized text in each chapter, and use the appropriate checklists. Refer back to specific chapters for more details. We have included removable cards in the back of the book that include the most critical information and checklists. References to peer-reviewed and published scientific articles that verify the statements in the book are included at the end of each chapter that includes references.

The formatting of emphasized text is continued in this edition based on the majority of feedback from readers of the first edition. A few readers felt the emphasized text was “shouting’ at them or questioning their intelligence. That was not and is not our intention. Emphasized text is included to allow rapid scanning to acquire important content.

This edition contains more information compared to the first edition for two specific reasons: 1) More information is available today, especially scientifically published evidence that confirms information in the first edition, and 2) this book is intended to be the most comprehensive reference available for patients considering breast augmentation. Each patient can consider her individual information needs and use the book as she wishes. The book is designed to allow patients to focus on essentials, yet have the most definitive information and scientific references available in one volume. Based on our more than 30 years’ experience, it is impossible for a patient to have too much information, because the quality of each patient’s decisions depends on the knowledge base the patient develops. “Too much information” is something no patient feels she needs... until something occurs which makes her wish she had acquired the information before surgery.

What We Are About--Our Beliefs and Biases

We believe that patients should be offered every option in breast augmentation. While offering options, surgeons are responsible for informing patients of the potential benefits, tradeoffs, and risks of each option. Every statement that we make in this book is backed by published scientific evidence and more than 30 years’ clinical experience. Biases based on scientific evidence are the basis of our track record. We believe that most patients are not provided optimal quality and quantity of information prior to having breast augmentation, and that some patients, despite the availability of quality information, do not commit adequate time and effort to become knowledgeable before making decisions about augmentation. Our commitment is to provide as much quality, science-based information as possible, and to assist every patient who wants to learn.

We believe that the best measures of the quality of breast augmentation surgery are 1) patient recovery, and 2) surgeon complication and reoperation rates documented in scientific publications or by the surgeon’s record in FDA monitored studies. Rapid, 24-hour return to normal activities, is a criteria that surgeon’s cannot easily manipulate for marketing purposes, provided patients insist on documentation of surgeon claims. The more tissue trauma and bleeding that a patient experiences during surgery, the longer the patient’s recovery, and the greater the risk of complications following surgery. Rapid recovery correlates directly with fewer complications and less risk of reoperations as confirmed in our scientific studies listed at the end of this introduction. Surgeon complication and reoperation rates are critically important, but are of limited reliability unless they are confirmed by peer reviewed and published scientific studies.

Other measures of results, including before and after pictures, are far less reliable as long-term yardsticks of patient outcomes. Pictures are often carefully selected by surgeons, and without at least five views of each patient preoperatively and at intervals postoperatively, even the most expert surgeons cannot make valid judgments of aesthetic results. Most patients, despite education, make very superficial and often incorrect judgments when viewing pictures. This statement is not meant to offend; it is simply true.

We believe that a patient’s highest priorities when considering various breast implant design options are 1) the scientific data and FDA data regarding the device shell failure rate (because device shell failure means a likely reoperation for the patient), and 2) each surgeon’s specific experience (numbers of cases treated) with each type of implant the surgeon recommends or does not recommend. The more experience a surgeon has with every type of implant, the more qualified the surgeon is to comment positively or negatively on that type of implant.

In our practice, we follow very strict guidelines that have evolved from our more than 30 year clinical experience—guidelines that are confirmed by our peer reviewed and published studies to deliver a level of recovery and reoperation rates that are currently unmatched in published studies worldwide. We have specific criteria for declining to perform augmentation. Some of those criteria include patients who do not wish to follow our patient education requirements, patients who make requests that we feel we will be unable to deliver for any reason, patients who do not fit clinical criteria for our practice, and especially patients whose tissue qualities are such that a breast implant could cause negative and irreversible tissue changes after augmentation. We would like for all patients to enjoy our practice, our personalities, and our care. Most do; some do not. Patients we decline to care for, despite the reasons, are usually not pleased, though a few have been very thankful. We are human; we are driven to deliver the best possible care for every patient, and we are far more concerned about documented quality of patient outcomes compared to any measure of popularity.

We love what we do, we are proud of our track record and encourage all patients to judge us and compare us to other surgeons based on track record, that is substantiated by scientific evidence and peer reviewed publications, not by unsubstantiated or unverified claims or marketing hype. Our goal is to deliver the best breast with the best recovery, and the best complication and reoperation rates, all documented by peer reviewed and published scientific studies.

Visualizing Your Quest for the Best Breast

Visualize your quest for the best breast as a staircase (Figure 1-7). Each chapter of this book represents one step on the staircase. The steps are divided into four main categories that approach augmentation in a logical sequence.

Part 1

Deciding Whether Even to Consider Breast Augmentation

To decide whether you even want to consider augmentation, you will need some information. In Part 1, we will present some hard choices and hard facts. If they aren’t acceptable, you don’t need to waste your time and additional resources.

Part 2

Learning What You Need to Know to Make an Informed Decision

Most patients don’t even know what they need to know to start considering augmentation. You need knowledge before you ever consult a surgeon. We think it’s critical for you to build a base of knowledge so that you can make the most of the time and money you spend consulting surgeons. A little homework in preparation for your consultations is invaluable. You will learn how to ask the right questions, how to separate substance from hype, and how to evaluate the surgeons you consult.

Part 3

Consulting Surgeons and Making Decisions

In part 3, you will learn how to locate qualified surgeons with appropriate credentials, how to gather and assess information from surgeons, how to define your expectations before seeing the surgeon, and how to get the most out of your consultations.

Part 4

Finalizing Your Decisions and Preparing for Surgery and Recovery

Finally, we will put it all together. In part 4, we will help you with the final choices—picking the surgeon, the implant, the pocket location, the incision location, and the time to have your surgery. After the choices, you will learn how best to prepare for surgery physically, mentally, and financially; what to expect during recovery; and how to live with your new breasts in the future.

Our purpose is to help you climb the stairs and meet your goals for the BEST BREAST. If you are considering breast augmentation, we want you to know as much as we can possibly share with you, based on our experiences as a team who provides information and surgical care to breast augmentation patients. Our hope is that sharing our combined knowledge and experience will help you, logically, one step at a time.

Let’s get started!

Summing Up

• The best breast is the natural female breast—until nature misses a beat or takes a toll, or a woman decides that it’s not.
• The basic components of the breast are
  1. a skin envelope and
  2. breast tissue filler (parenchyma).
• Following augmentation, the components of the breast are
  1. the skin envelope,
  2. the breast tissue, and
  3. the implant.
• Your expectations for augmentation must be realistic for you to be happy with the results.
• Your surgeon can only work with what you bring—your tissues and your expectations.
• The decisions that you and your surgeon make and the surgeon’s knowledge and execution determine your result, your experience, the rate of your recovery, and your risks of reoperations in the future.

Chapter 1 »

References

¹ Tebbetts, J. B. Achieving a predictable 24-hour return to normal activities after breast augmentation, part I: Refining practices using motion and time study principles. Plast. Reconstr. Surg. 109: 273-290, 2002.

² Tebbetts, J. B. Achieving a predictable 24-hour return to normal activities after breast augmentation, part II: Patient preparation, refined surgical techniques and instrumentation. Plast. Reconstr. Surg. 109: 293-305, 2002.

³ Tebbetts, J. B. What is adequate fill? Implications in breast implant surgery. Plast. Reconstr. Surg. 97(7), 1996.

⁴ Tebbetts, J. B. Use of anatomic breast implants: Ten essentials. Aesthetic Surg. J. 18: 377, 1996.

⁵ Tebbetts, J. B. Patient acceptance of adequately filled breast implants. Plast. Reconstr. Surg. 106(1): 139-147, 2000.

⁶ Tebbetts, J. B. Dual plane (DP) breast augmentation: Optimizing implant-soft tissue relationships in a wide range of breast types. Plast. Reconstr. Surg. 107: 1255, 2001.

⁷ Tebbetts, J. B. The greatest myths in breast augmentation. Plast. Reconstr. Surg. 107(7), 2001.

⁸ Tebbetts, J. B. A system for breast implant selection based on patient tissue characteristics and implant-soft tissue dynamics. Plast. Reconstr. Surg. 109(4): 1396-1409, 2002.

⁹ Tebbetts, J. B. An approach that integrates patient education and informed consent in breast augmentation. Plast. Reconstr. Surg. 110(3): 971-878, 2002.

¹⁰ Adams, W., Bengtson, B., Glicksman, C., et al. Decision and management algorithms to address patient and Food and Drug Administration concerns regarding breast augmentation and implants. Plast. Reconstr. Surg. 114(5): 1252-1257, 2004.

¹¹ Tebbetts, J. B. Out points criteria for breast implant removal without replacement and criteria to minimize reoperations following breast augmentation. Plast. Reconstr. Surg. 114(5): 1258-1262, 2004.

¹² Tebbetts, J. B., and Adams, W. P. Five critical decisions in breast augmentation using 5 measurements in 5 minutes: The high five system. Plast. Reconstr. Surg. 116(7): 2005-2016, 2006.

¹³ Tebbetts, J. B. Achieving a zero percent reoperation rate at 3 years in a 50 consecutive case augmentation mammaplasty PMA study. Plast. Reconstr. Surg. 118(6): 1453-1457, 1996.

¹⁴ U. S. Food and Drug Administration. General and Plastic Surgery Devices Panel Meeting Transcript. http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3989T1.htm, accessed January 13, 2007.

¹⁵ U. S. Food and Drug Administration. General and Plastic Surgery Devices Panel Meeting Transcript. http://www.fda.gov/ohrms/dockets/ac/00/minutes/3596ml.pdf, accessed January 21, 2007.

¹⁶ Health Canada. Transcript of expert advisory panel meeting on silicon filled breast imlants. http://www.hc-sc.gc.ca/dhp-mps/mdim/activit/sci-consult/inpmlant-breastmammaire/breast_implants_ intro_implants_mammaires_e.html. September 29-30, 2005. Accessed: November 26, 2006.

¹⁷ U. S. Food and Drug Administration. Product labeling data for Mentor and Allergan/Inamed core studies of conventional silicone gel

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