Archive for the ‘Breast Augmentation’ Category

SILICONE BREAST IMPLANTS - MENTOR - ALLERGAN - BREAST AUGMENTATION - DR MICHELE KOO, ST LOUIS, MISSOURI

Monday, May 11th, 2009

DR MICHELE KOO, MD, FACS, ST LOUIS, MISSOURI, 314-984-8331.

Dr Michele Koo, MD, Board Certified Plastic Surgeon, Member of the Aesthetic Society can create beautiful augmented breasts for you with saline or silicone breast implants. Your breasts can be enhanced to full, round, sexy breasts that still look and feel completey soft and natural. Dr Koo can create the breast cleavage that you have always wanted with breast enlargement using breast implants.

Dr Koo performs the breast enhancement with either an incision under your breasts or around your areola. She places the implants in one of two positions, either under your muscle or under your breasts. Dr Koo will decide the pocket for your breast implants after she examines you and determine which is the perfect surgery for you depending on what you want your breasts to look like. The surgery is an outpatient procedure under general anesthesia and you will be able to drive the next day and return to an office type occupation after 1 or 2 days. After the surgery you are given a surgical compression bra which you will wear continuously for 4 days. There is very little discomfort after the surgery and Dr Koo does not need to use pain pumps and you may only need tylenol or an anti-inflammatory medication after for the slight pressure that you feel.

You will be able to do light exercising in 2 weeks and full cardio exercising in 4 weeks. You will look awesome in a swim suit in 4 weeks and be ready for any social event with low cut dresses and tops in 2-4 weeks.

The breast implants that are available now are silicone and saline implants and both are perfectly safe. Dr Koo will use either MENTOR or ALLERGAN NATRELLE breast implants depending on the shape and size of your own breasts and what she feels she needs in order to make your breasts the best that they can be.

The surgery takes less than one hour and you will go home that day and feel fine by that afternoon. There is only some minor discomfort and pressure from the tight surgical bra that Dr Koo gives you. Dr Koo then sees you in the office 4 days after the surgery when you will be able to see your beautiful full augmented breasts.

The breast implants whether it is saline or silicone will need to eventually be replaced in 15-20 years. the replacement surgery is relatively minor and takes even less time than the original surgery if you do not need a breast lift or other procedures with your breast implant replacement. You will be able to still undergo mammograms with breast implants in place. Dr Koo’s office, St Louis, Missouri, 314-984-8331, will make sure that you are seen every year in follow-up with Dr Koo for a professional breast examination and that you will have regular mammograms according to recommendations depending on your age.

At the time of your breast augmentation, Dr Koo can also perform a breast lift if necessary or other procedures to correct any breast asymmetry.

Call DR MICHELE KOO, MD, FACS, 314-984-8331, ST LOUIS, MO, to begin your journey to feeling more confident and sexy with your very natural looking and feeling, full, round, sexy breasts after BREAST ENHANCEMENT - BREAST AUGMENTATION WITH BREAST IMPLANTS.

Tags: ALLERGAN NATRELLE Breast Implants, Augmented Breasts, BEAUTIFUL BREASTS, Breast Augmentation, BREAST AUGMENTATION EXPERT ST LOUIS, BREAST ENLARGEMENT, BREAST IMPLANTS, BREASTS WITH CLEAVAGE, FEMALE BREAST SURGEON ST LOUIS MISSOURI, FEMALE COSMETIC SURGEON ST LOUIS MO, LARGE BREASTS, LARGE SEXY BREASTS ST LOUIS, MENTOR Breast Implants, SALINE BREAST IMPLANTS, SEXY BREASTS, SILICONE BREAST IMPLANTS, ST LOUIS BREAST AUGMENTATION
Posted in BREAST IMPLANTS, Breast Augmentation, SALINE BREAST IMPLANTS, SILICONE BREAST IMPLANTS | No Comments »

BREAST IMPLANTS - BEAUTIFUL BREASTS - DR MICHELE KOO, MD, PLASTIC SURGEON, ST LOUIS - ILLINOIS, MISSOURI

Saturday, March 7th, 2009

BEFORE BREAST AUGMENTATION 34A

AFTER BREAST AUGMENTATION 34D

DR. MICHELE KOO, MD, FACS MISSOURI, ILLINOIS, KANSAS, 314-984-8331

Dr Michele Koo is a Board Certified Plastic Surgeon and a member of the Aesthetic Society, 314-984-8331, ST LOUIS, MISSOURI.

Dr Koo will give you specialized individualized attention for your special requests for your breast augmentation. She and her staff are tuned into serving your needs and wants and will give you customized individual service. Dr Koo’s philosophy is to make you happy and to serve you.

Dr Koo feels that there are certain facts that you should know about breast augmentation and breast implants and she wants you to be well informed. The better informed you are, the better your results will be as she will be able to communicate with you as to what your possibilities are. Her time is your time and she wants your surgery to be as perfect as it can be and that the size, shape, and look of your breasts will be exactly what you picture in your mind.

The following is an article in the Plastic and Reconstructive Journal that Dr Koo wants you to have access to by Dr William Adams of University of Texas Southwestern Medical University, December 2008. Dr Koo has her own techniques that are variants what is mentioned in the article but wants you to understand the preparation and techniques that go into determining your ultimate choice of implants, size, position, shape, and look of your breasts.

A process is defined as a group of practices that are completed successively to reach a goal. For 45 years, breast augmentation has been thought of as an isolated surgical procedure; however, well-documented elevated reoperation rates of 15 to 24 percent over 6 years in successive premarket approval studies have resulted in a critical analysis of this procedure. Factors that impact outcomes have been identified and practice recommendations have been established.

Background: Breast augmentation has been an integral part of plastic surgeons’ practices for over 40 years. Although devices have evolved, patient outcomes are still not ideal, as documented in multiple premarket approval clinical trials. Unlike many other areas of surgery, the practice of breast augmentation has suffered from the lack of a defined process for patient management. The purpose of this study was to clinically define and evaluate the process of breast augmentation and analyze patient outcomes using these practices compared with existing premarket approval trial data.

Methods: Three hundred consecutive primary breast augmentations from 2001 to 2005 were followed prospectively. Each patient underwent a defined process of breast augmentation including structured patient education and informed consent; tissue-based preoperative planning consultation; refined surgical technique; and structured postoperative instructions, management, and follow-up.

Results: The mean follow-up was 2.1 years. The most common complications were rippling and palpability, soft-tissue stretch, and hypersensitivity. The overall reoperation rate was 3.7 percent for the entire group and 4.7 percent and 2.9 percent for saline and form-stable cohesive gel implants, respectively.

Conclusions: Optimizing patient outcomes in breast augmentation requires defining the overall process to allow for enhanced patient outcomes. This is the first report that defines and integrates the entire process comprehensively that is validated by outcomes data. This process is transferable to other surgeons and, using this algorithm, patient outcomes in this study were superior to premarket approval clinical trial data. In summary, approaching this procedure with a global process produces superior patient outcomes in breast augmentation.

This analysis has resulted in a redefinition of this procedure to a much broader process beyond the actual surgical placement of the implant. Essential components include comprehensive patient education that enhances informed consent, tissue-based preoperative planning, refined surgical technique and rapid recovery, and a strictly defined postoperative management plan. Previous reports have defined individual key areas, and these principles have been integrated, refined, and customized into a comprehensive process that encompasses every key surgeon-staff-patient action point. Although each component may exist individually, the combination of these steps in succession has resulted in enhanced outcomes for patients far better than any one component practiced in isolation. In recent years, as key components of this process have been elucidated, it has been demonstrated that the process is transferable and reproducible. The purpose of this study was to clinically define and evaluate the process of breast augmentation and to prospectively analyze patient outcomes using these practices compared with existing premarket approval trial data.

All patients were treated by a single surgeon’s practice. Patients were followed prospectively from 2001 to 2006. A subgroup of the patients were followed in a U.S. Food and Drug Administration-approved clinical trial with clinical research organization oversight. The four primary subprocesses used for patient care were structured patient education, tissue-based clinical analysis, refined surgical technique, and defined postoperative regimen.

All patients underwent a patient education and informed consent process using a multimodality approach. Initial contact included verbal information and a web-based introduction to the practice philosophy of breast augmentation. Once the decision for consultation was made, a specific patient education consultation was performed to answer specific issues about breast augmentation. After 2002, a specific set of breast augmentation education and informed consent documents was customized based on previous publications in this Journal. Patients were required to complete the documents before their education consultation that was performed either over the phone or in person, lasting on average 45 to 60 minutes, and performed by a patient education specialist. During the education consultation, all concepts, issues, and limitations were addressed directly and covered with the patient, ultimately having the patient assume responsibility for the final decisions.

The surgeon consultation was performed only after successful completion of the education consultation. The average surgeon consultation time was 30 minutes. The two primary goals of the surgeon consultation were to objectively evaluate the patient’s breast and to ensure that the patient’s goals (previously defined in writing during the education consultation) were reasonable based on their breast dimensions and tissue. The tissue-based evaluation was based on previously published techniques. The basics of the High Five process allow the surgeon to preoperatively make the five critical decisions that determine outcomes for a breast augmentation:

1. Pocket plane.

2. Implant size (based on predicted tissue-based optimal fill volume of the breast).

3. Implant type.

4. Inframammary fold position.

5. Incision.

The implant size and type were based on two key factors: breast width and breast type (skin envelope compliance and preoperative fill). The rationale for selecting the individualized implant was reviewed with the patient and anyone else participating in the decision-making process.

The patient’s breast photographs were also reviewed with the patient and a photograph-analysis sheet was completed and initialed by the patient. Patient asymmetries were identified (size and shape) and discussed, and the reality that the postoperative breast will not match, realistic expectations for cleavage based on current intermammary distance, rationale for recommended pocket plane, and likelihood of implant palpability, particularly in the inferior and lateral parts of the breast, were all addressed directly with the patient by the surgeon while viewing the photographs.

The surgical plan was developed preoperatively following the surgeon consultation. All operations were performed under general anesthesia with short-acting full muscle paralysis, and patients were premedicated with a single dose of 400 mg of Celebrex (Pfizer, New York, N.Y.). The new inframammary fold incision was planned and executed as previously described. Implant pockets were created under direct vision with no blunt dissection using techniques to minimize tissue trauma. The same surgical principles were applied to all implant types, including smooth, round, and textured anatomical implants. Pocket preparation included the use of triple antibiotic irrigation and other techniques to minimize contamination of the implant, including glove change and wiping the skin before implant placement. Sizers were not found to be necessary in [297 of 300 (99 percent)] of cases, and the implant selection was determined during the preoperative consultation before the operative day. Incision closure was performed in three layers using a deep absorbable suture (3-0 Vicryl; Ethicon, Inc., Somerville, N.J.) for closure of the superficial fascia of the breast, a deep subdermal suture (4-0 polydioxanone), and subcuticular skin closure (4-0 Monocryl; Ethicon).

All patients were given detailed defined postoperative instructions. These were reinforced before the day of surgery and on the day of surgery, and verification of compliance was completed after the patient returned home. Patient outcomes, complications, and recovery were assessed and analyzed.

A total of 300 primary augmentation patients were followed prospectively between 2001 and 2006. Two subcohorts were also analyzed: (1) 128 consecutive patients undergoing saline primary breast augmentation from 2001 to 2006; and (2) 172 consecutive patients undergoing primary breast augmentation in U.S. Food and Drug Administration premarket approval clinical trials from 2002 to 2006 with standard clinical research oversight monitoring.

Patient demographics are listed. The mean age for the main cohort and subcohorts was 36 years. The average implant size was 289 cc for the entire cohort and 302 cc and 276 cc for the saline and form-stable cohesive gel subcohorts, respectively.

Details regarding the implant type and pocket plane are listed. The majority of all implants were in the dual-plane pocket. Ninety-eight percent of implants were placed by means of the inframammary fold incision.

Follow-up, patient outcomes and reoperations, and complications are listed. The mean follow-up was 2.1 years (range, 9 months to 6 years) for the entire cohort. Mean follow-up for saline and form-stable cohesive gel implants was 1.7 years (range, 9 months to 6 years) and 2.3 years (range, 1 to 5 years), respectively. The reoperation rates were 3.7 percent for the entire cohort and 4.7 percent and 2.9 percent, respectively, for the saline and form-stable gel implant subcohorts. The reasons for reoperation are listed. Ninety-seven percent of patients were able to return to normal activities of daily living (e.g., raise arms above head, drive car, wash, shop, eat, and dry hair) within 24 hours.

The belief that breast augmentation is a simple procedure encompassing little more than placing an implant in a pocket is a misconception, and advances in this procedure have been significant over the past 10 years; however, controlled clinical trials have demonstrated that reoperations continue to be significant (15 to 24 percent at 3 years) for this elective procedure. This procedure is much more complex than typically perceived, and the concept of the process of breast augmentation emphasizes the equal if not larger importance of the nonsurgical part of the process (e.g., education, tissue-based planning, and postoperative care compared with the surgical procedure itself).

The educational component cannot be overemphasized, as this remains the most critical yet often neglected part of the process. The key components of the educational subprocess are (1) to educate the patient on the practice philosophy and have the patient assume mutual responsibility that the implant will be selected based on her chosen preferences and in accordance with her breast dimensions and tissue or alternative methods recognizing the tradeoffs; and (2) by means of direct doctor-patient interaction to review the patient’s own photographs and point out key aspects that should be addressed preoperatively, including 100 percent asymmetry in all patients and limitation in correcting these asymmetries, reasons for implant palpability, and the likelihood of inferior and lateral pole deformity. The image analysis sheet is an extremely powerful yet simple tool that is part of the educational process and the surgeon planning consultation.

The tissue-based preoperative planning allows the surgeon to get on base and prevents the patient from striking out on her first try. The High Five process is one of two published and peer-reviewed tissue-based systems in the literature and provides the simplest way to determine optimal fill volume for any given breast. Patients often come to the office wanting to look like a certain centerfold or bathing suit model or be a certain bra cup size, but through the educational process and tissue-based planning it is made very clear that it is about their tissues. Interestingly, the High Five process allows the surgeon to adjust the volume based on patient request, and in a separate publication, this author has found a significant increase of complications when volume is added above the High Five-recommended volume, particularly in high-risk patients [narrow (breast width <11.5), tight envelope (skin stretch <2)].

Also cogent is the artist versus the engineer issue, and who should pick the breast implant size: the patient or the doctor. No doubt, much of plastic surgery is both art and science; however, art in itself is truly unstructured and without definable boundaries. The thought that instituting a process-oriented approach will obstruct the skills of the artist is a misconception. Realistically, the process will only serve to enhance one’s artistic qualities, as it defines the limits that the artistic only approach cannot clearly elucidate.

Formerly, the surgical technique was often the only part of a breast augmentation that many surgeons considered. Surgical advances have currently not only enhanced the actual surgical procedure but clearly defined the importance of the educational and tissue-based planning portions of the process, as these allow the surgeon to make nearly every decision before entering the operating room. This not only allows the surgeon to make better decisions than have historically been made in the operating room (particularly implant size) but also allows the surgical procedure to proceed as efficiently as possible. The concept of a very precise, atraumatic dissection with prospective hemostasis (identifying and controlling vessels and perforators under direct vision before they bleed) allows for both breast pockets to be typically dissected in a total time of typically less that 10 minutes. This not only immensely reduces the amount of tissue trauma but reduces intraoperative narcotics, additional paralytics, and the need for reversing agents, all of which slow postoperative recovery. Although the use of appropriate breast pocket irrigation has been widely accepted, surgeons often ignore other potential points of periprosthetic contamination, including handling implants without clean gloves and contact of the implant with the outside of the thermoform container or other surgical site components. These practices do not fit with this refined surgical process and should be avoided to minimize complications, including capsular contracture and reoperation.

The last benefit of this refined surgical process is recovery, the second best indicator of the quality of the procedure delivered (with reoperation rate being the first). This report and others have documented full return to normal activities within 24 hours using this process. In this series, 97 percent of patients (291 of 300) returned to full normal activities of daily living, including washing and drying hair, getting dressed, picking up children younger than 3 years, driving a car, and other similar activities. All aerobic activities that increase heart above 100 beats per minute were restricted for 2 weeks.

Surgeons, patients, and medical personnel are often skeptical about the feasibility of 24-hour, fast track recovery. The process is often modified but, as discussed earlier, a process only functions if it is completed in proper order and procedure. Other adjuncts to the process such as injectables, drains, pain pumps, straps, special bras, narcotics, and limitation of arm movements all detract from the goal of speeding recovery.

On reviewing the data of this study, it is interesting that the reoperation rates were low for all cohorts compared with all premarket approval studies. Also, the lowest reoperation rates were reported for the most stringent studies, with clinical research oversight. The issue of size exchange has also been of interest. There were no patients who underwent reoperation in either cohort for size exchange. It has been suggested that the rate of actual size exchange is dependent on the tendency of the surgeon to respond to a patient’s request for size change. This opinion does not take into account the theme of this article on the true power of the process of breast augmentation. Size exchange requests within the first 2 postoperative years that result in reoperations for size or style exchange indicate a failure of the surgeon and staff with the patient education and tissue-based planning parts of the process. A patient who has decided to select her implant based on her individual optimal fill volume and what will be safest for her tissues understands the limitations, and these patients remain well educated postoperatively and generally do not request size exchange procedures. This does not mean that these patients do not go through the normal human psychological acclimatization of getting accustomed to their new breast size and forgetting how they were preoperatively, which is normal human nature, and approximately 20 percent of patients may make a comment to our staff regarding size postoperatively, but they are reminded of the reasons why the size implant was chosen and shown their side-by-side preoperative and postoperative photographs, which usually results in them reaffirming their initial decision (documented in writing) about implant size selection.

Although not the focus in this article, other differences in these data are consistent with other reports, with a trend for less capsular contracture in the form-stable gel implants and more soft-tissue stretch in saline implants. There was more rippling and palpability in the form-stable implants compared with the saline implants in this study and there was more rippling and palpability in the Contour Profile Gel implant than in the 410, which is consistent with other reports and likely attributable to the increased form stability of the 410. Retrospectively, this is not visible rippling but implant edge palpability, generally an innocuous finding that resulted in no further surgical revision, and future studies on form-stable implants should separate these criteria to avoid confusion. The diagnosis in this study was made only if the patient complained about palpability. Nevertheless, excellent overall outcomes were obtained with all implant types using this process-oriented approach.

Also cogent is that surgeons and manufacturers often like to talk in terms of results with specific implants; however, in the end, it is not about the implant but rather the process, as this is the most significant benefit to patients. Advances in implants in the future will enhance the process but never replace it. The process determines the patient experience, reoperation rate, and recovery, and the overall quality of the process delivered is directly proportional to the overall success.

Perhaps the most significant factor is that the process is transferable. This author was inspired by his mentor, John Tebbetts, to take basic principles and refine, customize, and develop them for clinical practice and surgeon education. By means of focused education and a defined curriculum, surgeons can acquire the skill, knowledge, and expertise to deliver the process described in this study. Independent surgeons in different stages of their careers have reported using similar concepts to produce similar patient outcomes. The combination of these reports totals over 2500 primary breast augmentations, with a mean follow-up of 6 years and a reoperation rate of less than 3 percent. The transferability of this process has also been demonstrated routinely in our residency program at the University of Texas Southwestern. Interested residents have been introduced individually to this process and taken through the phases with direct supervision. It is clear with their own developing practices that they are using these concepts to obtain excellent outcomes in patients.

Limitations of this study and comparison include the fact that any comparison between a selected surgeon(s) versus a large premarket approval clinical trial is not totally an apples to apples comparison, although the premarket approval trial surgeons are hand picked by the manufacturer based on known expertise with the procedure. Because of stringent follow-up of U.S. Food and Drug Administration clinical trials with clinical research oversight, reoperation rates might be expected to be higher, yet a 5- to 7-fold increase is not explained by this minor factor.

Interestingly, the data in this study would suggest that, in this series, the subcohort of only U.S. Food and Drug Administration premarket approval clinical trial patients is easily comparable and slightly better than the non-premarket approval data. There have also been reports of premarket approval clinical trial series using similar concepts demonstrating a 0 percent reoperation rate at 3 years.

There has also been speculation that the U.S. Food and Drug Administration requirement for reporting of reoperations that included non-device-related issues, such as breast biopsy, falsely elevates the reoperation rates. When correcting for non-device-related reoperations (breast biopsy and excisional biopsy), the reoperation rates at 3 years in the core gel studies for the two companies were 14 and 16.5 percent, which would still indicate a 4- to 5-fold decrease in reoperation rates using the process detailed in this study. The reoperation rate in this study was 3.7 percent compared with 15 to 24 percent for the all premarket approval studies performed in the past 10 years. Reoperations remain our most objective measure of how well we are doing with this procedure. The 2-year reoperation rate is most critical because the majority of the reoperations during this period are the ones that are related directly to the surgeon’s decisions and technique.

Isolated processes in breast augmentation have been reported to improve outcomes; however, this is the first single-series study to integrate and report a comprehensive methodology to positively impact patient outcomes. Similar to the use of defined processes in successful businesses and industry, implementing a defined process in breast augmentation serves to systematize this procedure and ultimately helps reduce outcomes resulting in reoperation. The economic impact of the process of breast augmentation for patients and surgical practices, although not the focus of this study, is profound not only immediately but over time, as the trend positively impacts the global breast augmentation market. In the end, the biggest winner in the process of breast augmentation is the patient… as it should be.

Dr Michele Koo, MD, FACS hopes this is article is helpful. She and her staff work tirelessly to achieve the perfect result for you and to make breast augmentation a good experience for you that will enhance your life, self image and self confidence. Dr Koo is emphatic about communicating with you regarding your breast size, shape, and suitability for your lifestyle, body type, and cosmetic results. Dr Koo will work with you until she achieves those results.

Tags: BEAUTIFUL BREASTS, BIG BREASTS, Breast Augmentation, BREAST ENLARGEMENT, BREAST IMPLANTS, FULL BREASTS, SEXY BREASTS, SILICONE BREAST IMPLANTS
Posted in BREAST IMPLANTS, Breast Augmentation, Breast Lift, Breast Lift (Mastopexy) and Breast Enhancement, Lifted Breasts, SALINE BREAST IMPLANTS, SILICONE BREAST IMPLANTS | No Comments »

IMPLANT EXCHANGE - HARD UNCOMFORTABLE BREAST IMPLANTS

Friday, February 27th, 2009

Dr Michele Koo, MD, Board Certified Plastic Surgeon, St Louis, Missouri, 314-984-8331.

Breast augmentation is an extremely popular and safe surgical procedure that 100’s of thousands of woman have undergone without any complications. The majority of these woman are extremely happy and would choose to have to surgery again if given the choice to do over again. In 2007, the FDA again allowed the use of silicone gel implants for elective breast augmentation for cosmetic reasons.

However, with time and aging of the implant, the breasts may change and the implant become encapsulated (scar formation around the implant). The breasts may become hard and misshapened and painful. The breasts may become too saggy and heavy and extremely uncomfortable for the woman.

Breast implant removal and replacement along with a breast lift is very safe and often a normal sequelae to breast augmentation that is over 15-20 years old. The recommended life of a saline or silicone implant is approximately 15-20 years. Whether a breasts starts to show the changes of encapsulation (hardening) and pain depends on where the original breast implants were placed, the original type of implant, and, of course, the patient herself.

The surgery that needs to be performed to change the breast implants is largely dependent on what was done at the time of the original surgery, whether the implant was placed under the breast or under the muscle, what type of implant was used, and what the breasts look and feel like in its current condition.

A breast implant exchange or a complete breast implant removal without an implant replacement can be performed. If the breasts have become saggy and have fallen so that they are too low on the chest, a breast lift may have to be performed at the same time as the breast implant replacement or removal. All of the above procedures can be performed very safely in one procedure by DR MICHELE KOO, MD of St Louis, MISSOURI, 314-984-8331.

There are a few points that Dr Koo wants you to understand about breast implants and breast augmentation according to an article by John B Tebbets in the Journal of Plastic and Reconstructive Surgery.

Factors That Affect Responses to a Breast Implant

Every medical device implanted into the human body is placed in an environment where certain factors cannot be predicted or controlled by the surgeon or the patient, especially factors related to a patient’s individual wound-healing characteristics and the genetic characteristics of each individual patient’s tissues.

A breast implant has a range of effects when placed into the body, effects that continue for the entire time the device is implanted. Short- and long-term effects of a breast implant in the body depend on three different sets of factors: device-related factors, surgery-related factors, and factors related to the patient’s wound-healing and genetic tissue characteristics. Surgeons and patients have some level of control over device-related and surgery-related factors, including implant type and size, maximal soft-tissue coverage over the implant, and optimal surgical techniques to minimize tissue trauma and bleeding. Neither surgeons nor patients, however, can predict or control patient wound-healing and genetic tissue characteristics.

Factors That No Surgeon or Patient Can Predict or Control

No surgeon or patient can predict or control a patient’s wound-healing characteristics or a patient’s genetic tissue characteristics, factors that can affect outcomes following breast augmentation. Each patient has unique, individual wound-healing and genetic tissue characteristics that influence the interaction between a breast implant and the surrounding tissues. Individual wound-healing characteristics influence the characteristics of the capsule or lining that forms around every breast implant and affect the degree to which that capsule tightens or contracts, which in turn determines whether capsular contracture will cause excessive firmness of the breast or other deformities. A patient’s wound-healing characteristics may also affect the quality of incision scars, the risks of infection or fluid production around an implant, and other factors that can affect the aesthetic result. Genetic and hormonal effects of pregnancy and nursing vary from patient to patient and can affect aesthetic results and outcomes.

A patient’s genetically determined tissue characteristics can affect the response of the patient’s tissue to the implant, including how much the skin will stretch and thin in response to a specific size implant and how the breast tissue overlying the implant will respond. Surgeons and patients can avoid selecting excessively large implants, but even an appropriate-size implant for a patient’s visible tissue characteristics may cause excessive stretch of the breast skin envelope in patients whose tissues do not adequately support the weight. Unfortunately, surgeons have no tests available to predict a patient’s wound-healing or tissue responses to a breast implant. As a result, no surgeon can predict or control the occurrence or severity of capsular contracture, infection, tissue stretch deformities, or other conditions relating to patient wound-healing and tissue characteristics.

Reoperations: The Risks, the Tradeoffs, and the Logic

Every additional reoperation that is required following placement of breast implants imposes additional risks, costs, and tradeoffs to the patient. Some reoperations are medically necessary, but others are not. Severe capsular contracture, infection, and fluid accumulation around an implant are medical reasons to perform an additional operation. A patient’s request for a size change to a larger or smaller implant, though desirable to the patient, is not medically necessary and imposes risks and costs that may not be logical medically. For example, although the risk of infection with implant exchange is small, it is not zero, and for the patient who experiences such a complication, the incidence is 100 percent and may require implant removal without replacement or may produce an uncorrectable deformity.

Every reoperation causes additional surgical trauma and bleeding, and healing after each additional surgery produces more scar tissue, the effects of which are uncontrollable. Seemingly simple operations such as a minor revision for implant malposition or excessive stretch, though usually safe, invoke healing mechanisms that are uncontrollable and can result in exchanging one deformity for another. Logically, reoperations should not be performed for reasons that have no medical necessity or to address relatively mild aesthetic conditions where the risks and effects of the surgery might possibly produce a change that is worse or different compared with the existing condition.

Implant Removal without Replacement: The Logic

Breast implants are not medically necessary devices. Regardless of the efforts and costs to place breast implants, if certain conditions or complications occur, continuing to attempt to salvage the implants or leaving implants in place can cause permanent damage to a patient’s tissues, producing deformities that are uncorrectable.

Once a patient has breast implants, virtually every surgeon and patient wants to keep the implants in place. The positive effects of implants make some patients unwilling to even consider removal without replacement under any circumstances. Removal without replacement must be a joint decision of the patient and surgeon, both of whom must recognize and acknowledge that the aesthetic consequences of removing implants may be far more preferable to possible permanent, uncorrectable deformities and additional reoperations with additional costs and risks if the implants are left in place. Surgeons and patients should define criteria for removal without replacement before the patient has a breast augmentation, and the patient should understand and document her acceptance of these conditions in informed consent documents. A surgeon’s willingness to adhere to stringent criteria for reoperations directly influences reoperation rates, risks, tradeoffs, and costs to the patient.

Unilateral versus Bilateral Implant Removal

When a condition requiring implant removal occurs unilaterally, removal of one implant creates a deformity (asymmetry) that virtually guarantees at least one reoperation to replace the implant. Unilateral implant removal encourages patients and surgeons to prioritize implant replacement, often sooner than is medically optimal. Unilateral implant removal can compromise future decisions and the timing of those decisions. When removal is indicated, bilateral implant removal totally avoids these compromises and eliminates a demand for reoperation based on asymmetry.

Implant Removal without Replacement: The Criteria

Every surgeon must define personal criteria for implant removal without replacement, based on clinical experience, medical indications, and logic. On the basis of more than two decades of experience, I recommend breast implant removal without replacement for the following clinical conditions or situations, and I require that every patient accept and acknowledge these criteria in informed consent documents before the primary augmentation

* Recurrence of capsular contracture after having performed a complete capsulectomy and implant replacement with a new (textured saline if the primary was silicone gel filled) implant for a first capsular contracture of grade III or IV (limits total reoperations for capsular contracture to two).

* Recurrence of stretch deformity (bottoming, lateral malposition) after having performed a previous capsulorrhaphy, partial capsulectomy (if indicated), and exchange to a smaller implant (limits total reoperations for stretch to two).

* Traction rippling or visible implant edges medially when there is no additional tissue coverage available locally (e.g., conversion of submammary to subpectoral), or when pectoralis coverage has been previously compromised by division of medial pectoralis origins.

* Culture-documented contamination or infection of the periprosthetic pocket, regardless of implant type or pocket location (any occurrence of documented infection). This approach optimizes rapid resolution and minimizes inflammatory effects on tissues that occur with prolonged salvage efforts, effects that may produce significant and sometimes uncorrectable tissue deformities over time. Further, this approach minimizes the risks and costs of future reoperations attempting reimplantation, and it eliminates reoperations for recurrent infection or capsular contracture that can occur after attempted reimplantation.

* Recurrent seroma, regardless of negative cultures, after treatment of an initial seroma with exploration, capsulectomy (if indicated), and prolonged drainage.

* Inadequate soft-tissue coverage, when pinch thickness of tissues covering any area of the implant is less than 0.5 cm (except when coverage deficit is medial or superior and can be improved by dual plane or retropectoral implant placement).

* In any situation where two previous reoperations have been performed, for any reason (limits reoperations to three, including removal without replacement).

Criteria to Limit Reoperations

The following criteria have evolved over more than two decades to limit reoperations with their inevitable risks, tradeoffs, and costs:

* No reoperations for implant size exchange if not medically necessary (e.g., a slightly larger implant after performing a capsulectomy, provided adequate soft-tissue coverage is available).

* No reoperations for grade II capsular contracture.

* No reoperations for minor stretch deformities [<3 cm of additional widening of the intermammary distance due to lateral envelope stretch, <2 cm of elongation of nipple-to-inframammary fold distance (bottoming) 6 months or more postoperatively regardless of emptying of upper breast or slight excess volume in lower breast].

* No reoperations to adjust nipple-areola position if sternal notch-to-nipple distances are within 1.5 cm bilaterally (for either primary or secondary procedures).

* No implant replacement if patient has previously required bilateral implant removal for any condition or suspected condition, including replacement of saline-filled implants following removal of silicone gel-filled implants to address concerns of connective tissue disease or other undefined symptom complexes or psychological conditions.

* No reoperations if patient is unwilling to sign detailed informed consent documents acknowledging that she understands and accepts that every reoperation involves additional risks, tradeoffs, and costs, that correction of any condition by reoperation is not guaranteed, and that with any reoperation, we may exchange one set of problems or compromises for a different and not necessarily better set of conditions.

Results

The above-described criteria, combined with implant selection based on quantifiable tissue characteristics and more detailed patient education and informed consent were applied in 1662 reported cases using textured, saline-filled breast implants with up to 7 years of follow-up. The resulting overall reoperation rate was 3 percent. Acknowledging the limitations of comparing the studies, this 3 percent overall reoperation rate at up to 7 years compares favorably to the overall reoperation rates of 13 and 21 percent at 3 years in the saline premarket approval studies of Mentor and McGhan and to the 20 percent reoperation rate at 2 years in the most recent silicone gel premarket approval submission by Inamed Corporation.

Discussion

Factors such as the surgeon’s experience, the surgeon’s technical skill, the reasons for reoperations (device-related versus surgery-related), and other factors preclude direct, scientifically valid comparisons between our reoperation rates and those of the premarket approval studies. Nevertheless, the large clinical experience with long-term follow-up reported in our studies includes every reoperation for any reason, similar to the premarket approval study results. In the premarket approval study, capsular contracture was categorized as a device-related reason for reoperation when in fact surgical tissue trauma and bleeding are significant if not major stimuli for capsular contracture. A reoperation is a reoperation, regardless of whether the patient requests it for size change or an improvement in aesthetics. Selective categorizing and analysis to shade interpretation of results and causes is largely nonproductive, if reducing reoperation rates is a goal. By defining and implementing out points and decision and management algorithms, we have dramatically reduced reoperation rates in our practice over the past two decades.

Conclusion

To reduce the rate of reoperations, with their inevitable risks, tradeoffs, and costs to patients, and to reduce the incidence of tissue-compromising deformities resulting from multiple reoperations, surgeons must define strict criteria for reoperations following breast augmentation and for bilateral implant removal without replacement. The criteria described in this article resulted in overall reoperation rates that are substantially lower compared with overall reoperation rates in recent large premarket approval submissions to the Food and Drug Administration. Each surgeon must define criteria according to his or her individual surgical experience and practice characteristics, but current Food and Drug Administration rulings and guidance suggest that continued availability of breast implant devices for patients demands that patients experience lower reoperation rates.

Dr Michele Koo feels very strongly that her patients can benefit from primary breast augmentation for elective cosmetic reasons as well as from breast implant revisions should the need arise. However, as the article above emphasizes, re-operation for breast implants have certain risks and complications that are out of the control of the surgeon and the patient. Dr Koo wants the best outcome for her patients and she feels that the better informed one is when going into the initial surgery, the easier it will be for all subsequent surgeries.

Dr Koo wants her patients to understand that no matter how pleased you may be with the original breast augmentation or revision surgery that once a breast implant is used, that will then obligate you to subsequent surgeries whether it is for an implant replacement after many years, or whether it is due to your breasts changing shape and size after children or weight gain and loss.

Tags: BEAUTIFUL BREASTS, Breast Augmentation, Breast Implant Removal, Breast Implant Replacement, Breast Lift, breasts after nursing, Female Breast Surgeon, Hard Breast Capsules after Breast Augmentation, Hard Breasts, Hard Breasts Silicone Implans, Painful Breasts After Breast Augmentation, SILICONE BREAST IMPLANTS
Posted in BREAST IMPLANTS, Breast Augmentation, Breast Implant Removal, Breast Lift, Breast Lift (Mastopexy) and Breast Enhancement, Hard Breasts After Breasts Augmentation, Lifted Breasts, Painful Hard Breast After Breast Augmentation, SALINE BREAST IMPLANTS, SILICONE BREAST IMPLANTS, Saggy Breasts | No Comments »

BREAST AUGMENTATION - BREAST ENHANCEMENT SILICONE AND SALINE BREAST IMPLANTS PERFECT BREASTS

Friday, October 24th, 2008

BREAST AUGMENTATION SILICONE & SALINE IMPLANTS

DR MICHELE D KOO, MD, FACS

ST LOUIS, SPRINGFIELD, COLUMBIA, KANSAS CITY

MISSOURI

Before Breast Augmentation 32 B

After Breast Augmentation 34 D

Silicone breast implants have been again approved by the FDA for cosmetic breast augmentation by plastic surgeons. They are safe and may benefit so many woman who seek breast enhancement to feel more confident in themselves and feel better. No matter what your goal is for the look of your breasts, Dr Michele Koo, MD, FACS, 314-984-8331, understands what you want and will be able to deliver the perfect look to meet your goals. Whether you just want a little fullness or very full voluptous breasts, Dr Michele Koo can achieve what you are looking for safely and effectively.

To quote Rod J. Rohrich, M.D., co-editor of The Plastic Surgery Journal…….

“Nothing reminds me more of my duties as a surgeon than the words of Cicero: Salus populi suprema lex (literally, the safety of the people is the supreme law). The rough American proverbial equivalent that children across America hear every day is, of course, safety first. It’s a simple principle that guides my every action when teaching my students and treating my patients. Unfortunately, it’s a simple principle with a lot of gray areas. Safety can easily transform into paranoia, fear, and lost opportunities if we forget to balance our lives and ethos with well-thought-out risk, chance, and advancement.

With that in mind, the words of nineteenth century American theologian and editor Tryon Edwards ring inherently true in the sphere of science and medicine: Where duty is plain, delay is both foolish and hazardous; where it is not, delay may be both wisdom and safety. In early 1992, amid rising concerns, near-frenzied controversy, and legal actions against manufacturers, the U.S. Food and Drug Administration issued a voluntary moratorium on the use of silicone gel-filled implants for cosmetic breast augmentation.

With nearly 30 years of clinical experience proving implant safety, many thought that duty was plain and that the moratorium on silicone gel implants may have been overly cautious. On the other hand, it was true that the manufacturers did not, at that time, have adequate data to fully address some of the complex issues that had been raised.1 In this instance, despite the controversy and media hype, the duty was not plain and the issue was not clear-cut. The Food and Drug Administration’s decision to delay the manufacturing and use of silicone-filled implants was both wise and safe. The predominant notion at the core of the moratorium was patient safety, which should always come first.

Many of our patients had honest concerns that their silicone implants had caused major health problems, such as lupus and rheumatoid arthritis. Our patients were afraid for their health, and it was our and the Food and Drug Administration’s sworn duty to verify their safety. For the next 14 years, breast augmentation still proved to be a widely desired procedure, and saline implants filled the void left by silicone’s absence. Meanwhile, the Food and Drug Administration and several other independent organizations conducted experiments to prove that silicone gel implants did not cause systemic issues. After more than a decade of research and conversation, including the 1999 report by the Institute of Medicine and the 2005 Food and Drug Administration advisory panel hearing, during which the panel heard more than 20 hours of data presentations and public comment, the Food and Drug Administration made a decision.

On November 17, 2006, the Food and Drug Administration approved Allergan and Mentor’s silicone breast implants and placed the devices back on the U.S. market. Breast augmentation is a surgical procedure and, as with all operations, there are risks involved. Although silicone and saline breast implants both have the risk of localized problems, including capsular contracture, the Food and Drug Administration’s decision, in conjunction with research and reports from the last decade, showed that silicone gel-filled implants do not pose additional risk to women’s short-term or long-term health. The moratorium was the practice of due diligence, and our patients’ safety has been proven to the medical community, the government, and, most importantly, the patients themselves.

Reactions have been positive. Breast augmentation was the number one cosmetic surgical procedure in 2006, with more than 329,000 operations performed. This marked a 55 percent increase in the number of breast augmentations performed from 2000 to 2006 and the first time that the procedure was ranked as the most popular since the 1992 moratorium. In late May of 2007, a press release stated that over half of [American Society of Plastic Surgeons] member surgeons predict they will perform up to 25 percent more breast augmentations in the next 12 months and that 40 percent or more of all patients will choose SILICONE BREAST IMPLANTS. It is truly fantastic that women again have a choice in their breast augmentations, with two very safe and effective options at the core.

Our duty to our patients, however, is never complete. When considering the aphorism safety first, it’s hard not to take the sentiment one step further and consider these words: Safety first is safety always (quotation attributed to Charles M. Hayes).

While the American Society of Plastic Surgeons reports that four out of five members [say] that their personal concern for the safety of the implants was the least significant barrier preventing their patients from choosing silicone breast implants, 45 percent of members [say] their patients’ concerns about safety might be a significant barrier. It is for this reason that we will continue to work and investigate the safety of these implants, and that the Food and Drug Administration is requiring postapproval studies from both Mentor and Allergan; these postapproval studies include a continuation of the core study through 10 years (which will involve nearly 4000 patients), focus group studies of patient labeling, continued laboratory studies to further classify and investigate device failures, and tracking of each and every implant….”

As so eloquently said by Dr Rohrich, Dr Koo agrees that it is always with the patients’ safety that she is concerned and she will help you make the decision as to what surgery and what breast implant is best suited for you. She also takes a careful family breast cancer history and follows you in time to make sure that you have yearly breast examinations as well as mammograms. She truly feels that breast enhancement with silicone or saline implants is very safe and will do everything to help you maintain your safety with your newly enhanced breasts.

Dr Michele Koo, MD, FACS will help you achieve what nature left out and that is beautiful enhanced breasts with either saline or silicone breast implants. Patients from throughout Missouri, Kansas, and Illinois come to see Dr Koo for breast augmentation and breast lifts with breast implants. Please feel free to call for an appointment for your breast augmentation and breast enhancement 314-984-8331, St Louis, Missouri.

Tags: BEAUTIFUL BREASTS, Breast Augmentation, breast augmentations, Breast Enhancement, Dr Michele Koo, LARGE BREASTS, SALINE BREAST IMPLANTS, SILICONE BREAST IMPLANTS, Silicone gel-filled implants, St Louis Board Certified Plastic Surgeon, Voluptuous Breasts
Posted in BREAST IMPLANTS, Breast Augmentation, SALINE BREAST IMPLANTS, SILICONE BREAST IMPLANTS | No Comments »

Breast Augmentation and Breast Implants

Monday, September 15th, 2008

Beautiful Breasts

by Dr Michele Koo

Board Certified

Plastic Surgeon

St Louis, Missouri

314-984-8331

Before 34 small B

Beautiful Natural 34 D Breasts After Breast Augmentation

After 34 D

550 cc Silicone Moderate Plus Profile Implants

Safe pain free minimal recovery breast augmentation can be performed by Dr Michele Koo, MD, FACS in St Louis, Missouri. Dr Koo will determine the perfect breast implant and size for your body after you tell her what you want your breasts to be.

In November 2006, the FDA approved the return of the silicone breast implant for elective breast augmentation after lifting the 1992 moratorium on silicone breast implants for cosmetic breast enhancements. The implants are now multiple and varied and have different projections and sizes and textures.

Dr Michele Koo understands the safety of the different implants and will explain all the options available to you whether it is saline or silicone, or whether you need a lift or not, and the projection of the breast implant that is perfect for you. There are so many choices from which to choose, she understands what it is you want your breasts to look like and what to do to achieve those results.

Visit Dr Koo’s website at: www.drmkoo.com for more information and pictures.

Tags: Augmented Breasts, BEAUTIFUL BREASTS, Breast, Breast Augmentation, BREAST IMPLANTS, Female Breast Surgeon, LARGE BREASTS, SALINE BREAST IMPLANTS, SILICONE BREAST IMPLANTS
Posted in Breast Augmentation | No Comments »