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.
