BREAST AUGMENTATION (ENLARGEMENT)
Breast augmentation is the operation to enhance a woman’s breasts using prosthetic implants. If you are considering breast augmentation, you are not alone; it is the most popular aesthetic surgical procedure in the U.S. Whether you are looking for creating a breast when very little development has occurred, enhancement of the breast tissue you already have, creation of a more attractive shape, or to fill out a “deflated” appearing breast after nursing, breast implants are applicable. They provide a powerful psychological and physical boost to women who are unhappy with this part of their body. The vast majority of women who undergo breast enlargement are very pleased with their results and over 95% report years later that without question they would undergo the procedure again. In fact, it is not unusual for the daughters of previously augmented patients to also have the procedure. Very few women have their implants removed later in life because the size of their breasts becomes a positive part of their self-image.
Breast augmentation is usually less than a one-hour procedure. You are put under a general anesthetic by a board-certified anesthesiologist. An incision is made either in the crease under the breast, in the armpit, or through the areola (pigmented area outside the nipple) depending on your preference, the doctor’s recommendation, and the implant chosen. A space is created under or above the pectoral (chest) muscle, which is referred to as the pocket. The implant is inserted and the incision closed. After you are fully awake, you are discharged to home. Recovery is quick and you are able to be up and around that day. In fact, Dr. Creasman and Dr. Hwang encourage patients to move their arms over their head in a series of exercises described in the aftercare instructions. You will be seen 2 days later after which you are able to shower. Most patients return to work in 3-5 days. Returning to full activity or to work that is physical in nature takes longer.
Though complications are possible with any procedure, they are very unusual with this operation. They include bleeding, infection, numbness, changes in position of the implant including rotation, and asymmetry. Over time, risks include hardness of the breast because of scarring around the implant, drooping of the breast, palpable or visible rippling, a change of mind about the size, and leakage or fracturing of the implant. With highly textured surface implants, delayed development of a rare form of lymphoma (ALCL) has been reported to occur in the tissue surrounding the implant. If any of these problems occur, more surgery may be necessary and involve additional cost. Some women with implants may produce less milk when they try to nurse, especially when implants are inserted through the areola. Special methods are required during mammography after implants are in place. With silicone gel implants, the U.S. Food and Drug Administration recommends MRI surveillance imaging at 3 years and every 2 years thereafter to check for implant leakage. Newer imaging methods such as High Frequency Ultrasound and more recently Quantitative Transmission 3D Ultrasound (QT Ultrasound) have been developed that provide a suitable alternative to MRI.
Most of the work involved with having breast implants is in deciding if the benefits of having a prettier shape or larger size breast is worth the risks of surgery and the liability of having implants. Taking time with the doctor and other support staff in the office, involving family and/or friends as support systems, and undergoing careful, individual measurement and planning of implant size and type by one of our doctors is vitally important in achieving the best possible results. Our doctors have extensive experience and expertise in breast augmentation and employ unique tools such as 3D imaging to analyze your anatomy so the implants fit your body and look as natural as possible. We are very thorough and listen to what you want to achieve and then use your preferences to work with you to get the result you want, but in a safe and natural way. Patients who want a naturally larger look generally like our doctors’ results.
It is our opinion that it is important for patients to understand some details about how the operation is performed, what the recovery is like, what the risks of the procedure are, and what the typical appearance of implanted breasts are in our the hands. For this reason, we have developed this section of our website and an extensive photo library of patient results, all performed by our physicians.
While it is impossible to show every variety, size, and shape of breast that exists, we have tried to show average results in various scenarios. Though these results do not in any way guarantee that you will obtain the same exact result, they serve to demonstrate a level of competence and expertise by the doctors, and provide a visual basis for estimating the type of implant which would provide the patient with the desired result.
1. The Incision
To put it in simple terms, breast augmentation involves creation of a space, or pocket, into which the implant is inserted. Technically, breast enlargement is not a simple operation because often a relatively large pocket must be made through a very small incision in order to achieve an attractive result with the most inconspicuous scar. Incisions that are utilized for this operation include:
Inframammary – in the crease between the bottom of the breast and the chest wall (Figure 1). This is the most common incision and is required when using shaped, form stable (also known as “gummy bear”) implants.
Axillary – in the armpit (Figure 2).
Periareolar – at the junction of the dark and light colored skin of the areola (Figure 3).
During breast lifts, the incisions for skin removal are used when that procedure is combined with augmentation. Our doctors perform the procedure using any of these approaches. This will be discussed during the consultation.
2. The Pocket – Level of Placement
In addition to several types of incisions and implants, there are also two basic techniques of breast enlargement with regard to location of the pocket. In one, called subglandular, the pocket is made beneath the breast tissue, but on top of the pectoralis muscle (Fig. 4, right) In the other more common method, called subpectoral, the implant is placed beneath the pectoralis muscle, in front of the ribs (Fig 4, left).
The advantages of placing the implant above the muscle are that it is less painful for the first few days and the appearance of the implants matures faster (because skin stretches faster than muscle). Contraction of muscle, more noticeable in body-builders, has no effect on the appearance of the breast. This technique is utilized in women with slightly sagging breasts as the breast position relative to the underlying muscle has changed and a deformity known as a double mound is created if the implant is placed under the muscle, at the higher level.
The advantages of placing the implant under the muscle are numerous. First, it provides a more natural appearing breast with a better transition from the upper chest to the breast mound. This avoids “upper pole convexity” or roundness of the upper breast, which does not occur in nature. Second, the rates of scarring around the implant are significantly lower when the implant is placed beneath the muscle. Third, the risk of visible ripples or folds in the implant envelope (also a more common problem with saline than with silicone implants) is diminished because of the greater amount of the patient’s own tissue overlying the pbreast implant. Fourth, the ability to obtain an adequate mammogram is enhanced with placement under the muscle, as the mammogram technician is better able to separate the breast from the implant when the muscle is interposed. With the exception of patients who are body builders or competitive athletes, both of our plastic surgeons recommend placing the implants under the muscle.
3. The Implant
Significant advances and alterations have been made in the breast implant prosthesis itself since the original introduction of the silicone gel breast implant in 1962. The three main types of implants are the standard silicone gel prosthesis, the form-stable, cohesive gel (“gummy bear”), and the saline-filled prostheses. All of the envelopes are made of a solid type of silicone (Silastic), but the material inside each differs. In 1991, the Food and Drug Administration restricted the use of silicone gel breast implants to certain patients and until late 2006, access to this prosthesis was restricted to Plastic Surgeons participating in FDA sanctioned Clinical Studies. Dr. Creasman was an investigating surgeon in several of these studies. In 2006, the Food and Drug Administration lifted their 15 year moratorium on the use of silicone gel implants. A different implant known as the “highly cohesive gel” implant, which is filled with a more dense and sticky silicone gel material, was approved by the FDA in 2012. This implant is available in various round and teardrop shapes and because of the greater thickness of the gel, they hold their shape when upright. This provides a very natural look and better fullness in the upper breast. These implants have steadily gained in popularity among surgeons and patients.
Silicone gel implants have different characteristics than saline, some more favorable, some less. Without question, a more natural feel is achievable with a silicone gel device versus a saline device or a shaped device. Saline is not viscous like silicone so it moves around inside the pocket with more energy and this can lead to a greater tendency for the breasts to thin out over time and also for the wrinkles in the bag to be more apparent either by feel or even visually. Saline implants have about a threefold greater likelihood of leaking compared to silicone gel implants. While it is obvious when saline implants leak, with silicone implants often a leakage is not obvious and there may be no symptoms whatsoever (also known as “silent rupture”). For this reason, patients requesting silicone gel implants are advised by the FDA to obtain periodic MRI (magnetic resonance imaging) or ultrasounds of their breasts to ensure that the implants are intact. Silicone gel implants are more expensive than saline implants. You can read more about breast implants by clicking on the following link:
Dr. Creasman and Dr. Hwang use either smooth, round, responsive silicone gel implants or cohesive gel implants for most breast augmentations. Very few patients ask for saline implants, but in women 18-22 years of age it is the only FDA approved device. Round breast implants come in various widths and profiles (the amount they project from the chest wall – best seen when you are looking down). They are referred to as low profile, Low plus profile, moderate profile, full profile and extra full profile implants. Most patients use moderate profile implants. In very petite patients with narrow breasts who desire maximum augmentation, a high profile implant provides a means of enhancing volume without over enlarging the width of the breast. High profile implants tend to look rounder, particularly in the upper “pole” of the breast when looking at the side profile of the breast, and they are heavier. In women who already have a fair amount of breast tissue and wider breasts and only want a small degree of enhancement, the low or low plus profile implant may be the best choice. The figure below (figure 5) shows five implants of the same base width, but with the five different profiles (and of course, different volumes).
Cohesive gel (also known as form stable implants) round or shaped implants – commonly called the “gummy bear implant” (figure 6) – are filled with one of two types of highly cohesive silicone gel and come in both round and teardrop shapes. This allows the implant choice to be tailored specifically to your particular shape. Round implants don’t always fit every breast shape, so it is helpful to have shaped implants available. Recent studies have shown that the cohesive gel implants have a lower risk of capsular contracture, movement over time, and leakage. They are firmer to the feel compared to silicone gel implants, but are more natural feeling than saline implants. If you want to have a breast that maintains fullness on the top, then a highly cohesive implant may be a better choice. They are also useful in very thin women to reduce the risk of visible rippling.
One issue that has recently been recognized is BIA-ALCL (see FAQs below) which is associated with highly textured surface implants. The teardrop implants are all textured to prevent them from rotating. For this reason, out of an abundance of caution, we have discontinued the use of all textured implants including teardrop shaped implants until more information becomes available that convinces us that they are as equally safe as smooth surface implants. We will show you samples of each.
One of the most essential factors in achieving your goals is the individualization in planning and carrying out the surgery. The following represent aspects of this of which all patients should be aware:
Achieving ideal enlargement and consistency (softness) is more difficult in breasts that are extremely small and in which there has not been stretching of the skin from pregnancy or hormonal stimulation; however, in a high percentage of patients, this goal is still achievable.
A moderate amount of stretching of the breast skin and a slight amount of sagging as a result of pregnancy can be desirable since this permits greater enlargement without sacrificing softness.
Sizing breast implants is an important issue both for you and for the doctor. Most patients want to achieve a natural looking result. Trying to predict bra cup size when planning this operation is almost impossible. Any woman knows that depending on the manufacturer, style, and preferred fit, bra sizes vary widely for a given size breast. For this reason, and the fact that breast implants are not manufactured in cup sizes, we utilize a sizing method which is based on a woman’s own body measurements. Dr. Creasman worked with a start-up company to help develop one aspect of a 3D breast imaging system. The device our doctors use is called the VectraXT machine. It involves taking a picture with a special camera that allows your torso to be viewed in 3D from any point of view, automatically measures you, analyzes your anatomy for symmetry (evenness), shows variations in how your ribs are shaped, and then can show you how various sizes and types of implants look both in and out of clothing. Since we began using it in 2008, patient satisfaction and trust have improved because 3D imaging is a wonderful communication tool. Patients find it invaluable in making a decision with the doctor what size implant to use. A range of implant sizes is suggested to each patient, and ultimately size choice is up to each patient within the guidelines provided by the doctor. This is a collaborative process between you and your surgeon, but the most useful advice is for each patient to follow her own anatomy rather than trying to aim for a particular bra cup size, which may or may not be achievable or appropriate.
Read more about the 3D Breast Imaging here: http://creasman.com/4d_simulations.htm.
With your consent, the doctor can forward the 3D images to you via a secure server maintained by the imaging company. This allows you to review the 3D images and simulations at home and show them to your spouse or other family/friends as you think through the process of coming to a decision about your breast augmentation.
If significant sagging of the breast has occurred (called ptosis), then simple enlargement of the breast with an implant will not suffice. In this case, the breast must be re-contoured as well as enlarged, and this requires a different operation, which is known as a mastopexy. If this is a factor pertinent to your situation, this operation will be discussed in detail with you, but you can also click here to read more: https://www.creasman.com/breast_lift.htm.
In women who have been nursing, a period of time must pass after the complete weaning of the baby from the breast. The doctors will not perform breast augmentation for at least three months after the last signs of milk flow. This is to avoid incising into milk producing breast tissue, which can lead to complications of a galactocoele (milk cyst), or infection, or both.
Some asymmetry (difference in size and shape) of the breasts is normal. Every attempt is made to improve or correct this asymmetry at the time of surgery, but perfection cannot be achieved. (See section on Breast Asymmetry: https://www.creasman.com/breast_prob.htm)
Before Your Procedure
Scheduling surgery involves payment of a non-refundable deposit, as there are costs involved with preparing for your operation, and for reserving the time. A PERIOD OF AT LEAST TWO WEEKS OFF ANY MEDICATIONS CONTAINING ASPIRIN, IBUPROFEN, VITAMIN E, OR OTHER MEDICATIONS THAT COULD ADVERSELY AFFECT THE BLOOD CLOTTING MECHANISM, IS REQUIRED TO PREVENT ANY BLEEDING COMPLICATIONS. At the time surgery is scheduled, a pre-operative visit is also scheduled approximately two weeks prior to the date of the operation, and takes approximately 30 – 45 minutes. Per current American Cancer Society recommendations, in women aged 40-45, a baseline mammogram is optional. In women aged 45 and older, a baseline mammogram is recommended prior to surgery and the report needs to be reviewed by our doctors prior to surgery. At the preoperative visit, a surgical consent, an implant consent and a photography consent are signed. The size of the implants to be used is finalized. Photographs are taken. A directed physical exam is carried out. All questions relating to the surgery are answered in detail and one of our nurses or doctors will go over the details of what to expect after surgery. We will advise you which bra to purchase for your recovery. You will be provided with a detailed written set of instructions that we would like you to review prior to your breast augmentation procedure.
The operation usually requires one hour of operating time and one hour of anesthetic recovery. You will have a general anesthetic. A Board-Certified Anesthesiologist provides the general anesthetic, which will give you the greatest degree of comfort during the operation. You will be completely unaware of the experience and feel absolutely no pain whatsoever. The surgeon will administer local anesthetic nerve blocks during the procedure that numbs your chest with a long lasting medicine. This provides you with pain relief after surgery for several hours. At the conclusion of the procedure you will be placed into your bra.
The Recovery Period
Because of the use of sedative medications, it is absolutely essential that a responsible adult escort be available to transport you to and from the operation. By law, we cannot discharge you to an Uber/Lyft driver or taxi without someone you know to accompany you. You will need someone to be available for the first 24 hours. During that time, the caretaker person will assist you in getting up to the bathroom, taking medications, and preparing meals. Most patients rest for the first 12 hours after surgery, but you may get up and walk around.
Your surgeon will call in the evening to check up on you. You need to anticipate some discomfort until the level of the narcotic pain medication reaches sufficient levels in your bloodstream. This usually takes a double dose of the pain pills for the first two to three doses, after which a single dose is sufficient to maintain control of the pain. You may also be prescribed a non-steroidal anti-inflammatory medication that is to be taken in addition to the narcotics. Do not take any other medications unless this is cleared through our office, to avoid medication-related complications. You do not need to discontinue your birth control pills, however one of the medications that we prescribe to prevent nausea may make hormonal contraception methods ineffective (birth control pills, patches, implants and some IUDs), so you will need to use an alternative form of contraception for one month after surgery such as condoms and/or spermacides. We also provide a prescription for suppositories to help fight any nausea you might have from the anesthetic. Take them only if necessary.
Activity should be restricted to no lifting, pushing, pulling or driving for 48 hours. It is not advisable to drive a motor vehicle until one is completely off narcotic pain medication and there is no restriction of upper extremity mobility. The bra is left in place until the first post-op visit, and the breasts must be kept dry. A small amount of oozing at the incision sites is to be expected. The breasts should not be manipulated in any way. One should be up and walking on the evening following surgery, and a light solid diet begun to the point of tolerance. Stretching exercises are recommended during the evening of the surgery and these will be demonstrated to you by the nursing staff or doctor at your preoperative visit.
Certain events should be reported to the office immediately: A temperature over 99.5 degrees, chills or sweats, a markedly different degree of swelling between sides, and/or increasing rather than decreasing pain.
At this point in the recovery, it is normal and expected for breast implants to ride up higher on the chest than they will ultimately rest. The skin and muscle are still tight, there is swelling from the surgery, and this all needs time to resolve. Typically, this period of settling takes 3 – 6 months, but varies from patient to patient. Here are images of a typical patient pre-operatively, at 2 days, and at three months (Figure 7).
Patients are seen 2 – 3 days after the operation and their bandages removed and the healing assessed. Patients are then allowed to shower and to wash their hair. Tapes on the incisions can then be gotten wet, but the incisions should not be submerged, as in a tub or pool. Most patients can resume a reasonably normal activity pattern and non-exertional type job situations within 3-5 days after surgery.
With smooth implants, massage exercises are begun at the first post-operative visit and are done with greater frequency early on to displace the implant around the generous pocket, in an attempt to prevent the body from closing down the pocket and compressing the implant. It is painful at first, but quite rapidly this becomes very tolerable, and it is essential to establish this large pocket early in order to obtain soft breasts. With shaped implants, massage exercises are not done.
Risks of Breast Augmentation
Surgery of any kind, no matter how expertly performed, involves some degree of risk. Having breast implants placed involves accepting liability that was not present prior to their implantation. Some women cannot handle any further responsibilities in their lives. If this is the case, you should not have this operation. It is not for everyone.
What are the surgical risks?
Bleeding (hematoma formation) – Abnormal bleeding into the space around the implant can occur after surgery in about 1% of patients. If bleeding occurs in any significant amount, a return to the operating room is necessary to remove the blood and control the bleeding, since not to do so would produce an abnormal shape of the breast and increase the chance of postoperative hardening.
Infection – Because the ducts of the breast contain bacteria normally and are moved around in the process of making the pocket, all patients are given a dose of intravenous antibiotics just prior to the operation to reduce the risk of infection. The implant space and the prostheses are bathed in a potent antibiotic solution as well. Our surgeons use a device called the Keller Funnel to insert the implant, which completely prevents the implant from touching the skin. The protocol has kept the risk of infection to approximately 1% or less.
Loss of nipple sensation – Most patients have some partial loss of feeling of the lower part of the breast for several months following the surgery; this is due primarily to the stretching effect of the implant on the nerves in this area. It is also not uncommon for patients to develop irritability or hypersensitivity of the nipple and areola within several weeks following the surgery; this represents regrowth of the nerves that are cut where the incision is made and usually lasts only several weeks. It is unusual for any permanent loss of sensation to occur after the surgery, but it can occur in about 5% of patients.
Malposition of implants – Particularly in patients with existing asymmetries, adjustments to the position of the inframammary folds can be done to attempt to correct the asymmetry. This is rarely perfect, and sometimes requires revision if it is possible to improve it further.
What are the long-term risks of breast implants?
Changes in breast shape over time, e.g. sagging (ptosis) – Either with or without implants, breasts can sag. This is more common after breast feeding or marked weight loss, but also occurs with age. If your breasts droop after you have implants, you may need a breast lift to correct the drooping and you may need to change out the implants. Over enlargement increases the likelihood of stretching of the breast skin, thinning out, drooping and this may increase your risk of needing more surgery.
Capsular contracture (hardening of the breasts by the presence of scar compressing the implant) – Part of the normal healing in every patient who has breast augmentation surgery is the formation of a thin membrane of scar by the body’s immune system, which is termed a capsule. This is a normal aspect of healing, and always occurs because the implant is a foreign object. What varies is the tendency of some capsules to contract or squeeze down around the implant (like heating “shrink wrap”). If this occurs, the breast will feel firm and can become distorted, usually by becoming more ball-shaped and often riding higher on the chest. It can happen on one side only. It tends to occur, when it does, earlier rather than later. It can occur to varying degrees of severity, with the most severe form actually causing breast pain. The rates of occurrence with subpectoral placement of a silicone gel implant are approximately 10-15% of cases, but only 9% in cohesive gel implants at 10 years after surgery. The treatment is surgical removal of the scar (capsulectomy) and replacement of the implant. The problem can re-occur, as there is no definitive cure. The tendency to develop this problem is not something that can be predicted by any available test. Massaging round gel implants to maintain the large size of the created pocket is the only thing a patient can do which possibly reduces the incidence of this problem, and has been very successful in our practice.
Interference with mammography – X-rays do not pass through breast implants, so breast on either side of the implant is obscure. Placing an opaque object next to the breast interferes to a variable extent with the ability to mammogram the breast for breast cancer screening purposes. However, placing the implant behind the muscle provides the ability to displace the implant away by pulling the breast forward into the mammography machine. This method, known as the Eklund technique, has improved the ability to see most of the breast such that the presence of implants does not represent a statistically significant risk to patients of missing an early breast cancer.
Deflation – As strong as they may be, Silastic bags can and do occasionally leak their contents, which in the case of saline-filled implants is IV grade saline (the same salt water that makes up approximately 70% of our bodies). The incidence ranges between 1.5 – 2% per year if the implant is properly “over-filled”. The usual cause of saline implant deflation is scar tissue ingrowth at the fill valve site. This is unpredictable and cannot be completely prevented, but “over-filling” places more pressure on the valve and reduces the likelihood of deflation. With silicone gel implants, there is no valve, but the shell or bag can split and release the gel contents. This is an event that occurs in about 0.7% of implants per year. Since in most patients leakage of silicone is not accompanied by any symptoms, the FDA recommends periodic MRI surveillance of silicone gel implants. The current recommendation is that an MRI be obtained at 3 years after implantation, and then every two years thereafter. There is also new technology, known as QT Ultrasound, that may be equivalent or possible superior to MRI. We plan to participate in a research effort to study this. Unfortunately, physical examination is not reliable in detecting silent implant ruptures. Implant manufacturers provide lifetime warranty coverage for this complication, and usually pay for some of the costs of the surgical room and anesthesia for a period of ten years as well. Though a medically harmless complication, treatment of implant leakage involves going back to the operating room and re-entering the pocket through the same incision (unless it was done through the armpit) and replacing the implant. Many experienced surgeons feel that deflation is inevitable with a saline device, but there is no reason for implants to be routinely replaced if they remain intact. In the event of a deflation, you should seek treatment promptly as the collapsed implant pocket will shrink rapidly, and if a new implant is not replaced within a week or so, this may require additional surgery to correct.
Interference with breast-feeding
– Though uncommon, it is possible to divide the ducts that empty the breast gland and thus interfere with lactation when the procedure is performed via the periareolar approach. Additionally, the breasts may be too uncomfortable when engorged, and so lactation may be hindered in this way.
– In very thin patients with very little of their own breast tissue, the saline implant in particular can reveal itself with visible folds and creases. The larger the implant, the greater the likelihood of this complication. This is a much more common problem with textured implants than with smooth implants. It is also more of a problem when the implants are placed above the muscle. The implants are actually overfilled at the time of placement to distend the envelope such that this complication is mitigated, but over time as the skin thins out from the weight of the implant, this can become worse. The treatment is replacement with a highly cohesive silicone implant, and even this sometimes does not completely eliminate the issue.
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) – A rare form of lymphoma has been found in proximity to (usually textured) breast implants. BIA-ALCL is not a cancer of the breast tissue itself, but of the scar capsule. Patients typically present an average of 8 years after surgery with enlargement of their breast due to fluid accumulation around their implants. Any fluid that develops around the implant is drained and tested. In the rare event that the tests are positive for ALCL, then removing the capsule and implant are usually curative, but some patients may require chemotherapy. The lifetime risk of developing this tumor is 1:30,000, or 0.003%. To date, there have been fewer than 20 deaths worldwide since the first reports of the disease 20 years ago. Though factors such as textured surface, bacterial contamination, and genetic factors have been implicated, to date there is no known cause of BIA-ALCL.
The female breast is an important symbol of femininity and sexuality to both women and men. Having fuller breasts often enhances clothing choices. It is therefore very natural and normal that most women would desire to maintain or achieve an attractive or pleasing breast contour. What is most attractive in practically every feature of the body though, is proportion.
Some women suffer a great deal of emotional frustration and anxiety because of the small size of their breasts, because of breast asymmetry, because of sagging breasts, because of post-partum changes, or because of a disproportion between the size of their breasts and other body areas. It is fortunate that plastic surgery has the technology to address dissatisfaction with breast size and shape. We can make breasts larger, but also prettier.
Many women approach this process with feelings of apprehension, so we have provided here as much available information as we can to allay any anxiety. We understand that this is a big decision and we approach this in a thoughtful way that takes into account every individual’s goals and body type. It can take months to fully appreciate the overall value of the results and to incorporate the new look as part of your overall body image. Of course breast augmentation cannot solve all of life’s problems, but it is remarkably powerful and can improve your self-image and self-confidence, and make a significant and long-lasting contribution to your overall happiness.
View Before and After Pictures Make an Appointment Finance It!
Frequently Asked Questions
Q: Do breast implants cause breast cancer?
A: There is absolutely no evidence that the breast implant predisposes the patient toward or in any way causes breast cancer. Evaluation of breast tissue by clinical examination and mammograms is somewhat more difficult with an implant in place, but with special techniques is still very satisfactory. If you were to develop breast cancer, studies have shown that the stage of the disease at the time of diagnosis is not greater than women without implants, so the presence of implants does not delay the diagnosis and survival rates are the same.
Q: Do all breast implants break and do I have to have them replaced every 10 years?
A: The breast implants do not deteriorate or decompose in the body and the silastic bag does not migrate away from the local area of implantation. Despite what is often found on Google searches, there is no reason to routinely replace an implant after a specific period of time (e.g. 10 years), though patients are often led to believe this.
Q: Will my breasts eventually sag if I have implants? Am I going to eventually going to need a lift?
A: Assuming normal tissue and a properly performed operation, a breast that has been augmented will not sag any faster than a natural breast of the same size, however this is not the case when excessively large implants are placed. If they are heavier then the tissue may not support them. The assessment of your tissue characteristics is a very important part of the consultation with our doctors.
Q: Is my breast function affected by the implant? How about my chest muscle?
A: There is no interference with the function of the breast or the chest (pectoral) muscle, and permanent interference with feeling or sensibility of the nipple is unusual (5% or less).
Q: If I have sagging breasts, will implants correct this?
A: Breast implants do not “lift” the breasts (we can’t fill them with helium!). They may fill out a loose envelope of skin that can create the illusion of lifting, but true lifting does not occur with implantation of a fluid-filled mass. If anything, breast implants add weight to the breasts, and women who have them must be more mindful of wearing a bra to keep them from sagging over time.
Q: How long does it take to get used to having breast implants?
A: Once healing is complete, the patient loses a subjective awareness of the implant, and incorporates it as part of her body image quite rapidly. The improvement produced by the implants is noticeable immediately, and there is very little swelling and bruising produced by them. However, the final appearance of the breast does not occur for several months because of the need for the tissues of the chest muscle and breast to accommodate to the size of the underlying prosthesis. In the interim, the breasts sometimes appear unnaturally high on the chest, and the skin feels tight. This is temporary and improves strikingly over the first three months. The most important thing to remember is that this is a normal and natural phenomenon and is unavoidable.
Q: Do the implants change over time?
A: Changes continue to occur in the breast due to the presence of the implant for many months. Many patients report a perceived shrinkage of the breasts at a year following surgery. This is most likely due to the compressive effect of the mass of the implant on the breast tissue. This can be seen on mammograms, and is similar to a sponge being squeezed. There may also be a purely psychological tendency to adjust one’s personal preference about size after having undergone the procedure. There is a natural tendency to “want more of a good thing”. Though there are obvious examples of “too much of a good thing” in the media, please understand that one invites problems with over-enlargement including thinning of the skin, wrinkling, stretching of the lower breast skin, and bottoming out. Correction of this permanent soft tissue damage is complicated, expensive, and usually incomplete. This will be explored in greater depth during the consultation.
The following questions address recent concerns regarding BIA-ALCL and BII. The answers are extracted from the American Society of Aesthetic Plastic Surgery website:
Q: What is BIA-ALCL?
A: (Breast Implant-Associated Anaplastic Large Cell Lymphoma) is a rare spectrum of disease that can range from an indolent accumulation of fluids around the breast (seroma) to a potentially metastatic lymphoma especially when there are delays in diagnosis. It is a disease that ranges from indolent to full-blown metastatic disease when not caught early. BIA-ALCL is not a cancer of the breast tissue itself. When diagnosed early, it is readily curable. If the disease is advanced, chemotherapy or radiation may be required.
BIA-ALCL is currently classified as a lymphoma. Many experts believe that it behaves clinically as a lymphoproliferative disorder (LPD) that encompasses the spectrum of disease from benign CD30+ seromas, to CD30+ malignant seromas, to invasive capsular disease, and finally metastatic disease. Current ASERF research is underway to further understand the proper classification of this disorder. Similar to LPDs, BIA-ALCL is a highly treatable disease with high cure rates.
Q. Have there been any deaths due to BIA-ALCL?
A. As of July 24, 2019, FDA reports that there have been 33 confirmed deaths globally, (13 in the United States), attributed to BIA- ALCL since the disease was first reported nearly 20 years ago.
Q: What are the symptoms of BIA-ALCL?
A: The first symptom of BIA-ALCL is usually a swelling of the breast between 2 to 28 years after the insertion of breast implants, with an average of about 8 years after implantation. The swelling is due to a collection of fluid surrounding the implant. This fluid can cause the breast to enlarge significantly over a period of days or weeks. It can also present as a lump in the breast or armpit, firmness of the breast, or pain. It is usually easily and completely treated if patients see their doctor at the first symptom.
Q: What is the risk of developing BIA-ALCL?
A: The FDA reports that it is 1:3,817 to 1:30,000 in their latest statement. These risk assessments are changing on an ongoing basis, but this is the most accurate information currently available.
Based on current data, the risk can be further explained by the texture grade of the implants as follows:
- Grade 1 (Smooth only) – In global databases, there has not been a confirmed case of smooth only. In the Feb 2019 FDA statement, it was reported that “there have been reports of BIA-ALCL in patients with smooth-surfaced implants and many reports do not include the surface texture of the implant at the time of diagnosis.” At the time of this publication it is known that a single case of smooth only BIA-ALCL was originally reported to the FDA; however, it was later determined that this was not accurate and the case was a mixed implant case, and the report to the FDA was amended.
- Grade 2 (e.g. Microtexture, Siltex and similar) – 1:82,000
- Grade 3 (e.g. Macrotexture, Biocell and similar) – 1:3,200
- Grade 4 (e.g. Polyurethane) – 1:2,800*
*Based on data form an Australian study – however this was 100% Silimed PU implants that had a manufacturing defect and have since been taken off the market.
Loch-Wilkinson, A., et al. (2017). “Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk.” Plast Reconstr Surg 140(4): 645-654
On July 24, 2019, Allergan reported a voluntary recall of all BIOCELL textured implants and expanders, worldwide. The recall includes the Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.
The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs. This recall was requested by FDA.
“Based on the currently available information, including the newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the US,” the FDA said in a statement.
Q: What does FDA mean by a “recall”? Should current BIOCELL patients be contacted and explanted?
A: This is recall of inventory Biocell and sold Biocell products but not implanted Biocell implants in asymptomatic women. The FDA does not recommend or suggest that asymptomatic patients be explanted; rather that that the company refrain from selling BIOCELL implants moving forward. Dr Creasman and Dr. Hwang are contacting patients in our practice who have textured implants to offer a free evaluation with one of the doctors. Though we do not recommend prophylactic removal of textured implants in asymptomatic women, we realize some patients will elect to have their implants removed for personal reasons. Allergan is now offering free replacement implants even in patients without symptoms. There are still costs associated with the surgery and these would need to be discussed at a follow up visit.
Q: If a breast implant patient sees a plastic surgeon when she develops a first symptom, will she be cured?
A: That answer is not known and is a very important piece of information for patients and plastic surgeons. Most of the time patients see their plastic surgeon right away when they develop significant swelling of the breast. In these cases, the disease is almost always caught early and cured with a straightforward operation. Some women with advanced disease ignored earlier symptoms or saw a doctor who did not properly diagnose them. There are a few patients who presented with advanced disease who said that they never had earlier symptoms.
Q: Can you explain the differences in implant texture and what role that factor plays in the research?
A: Although it is rare, BIA-ALCL appears to currently develop exclusively in women with textured implants. To date there has not been a case of BIA-ALCL in a patient with only smooth implants. There are several theories which attempt to explain the higher rate for textured implant patients: many believe that the increased surface area of textured implants allows a higher number of bacteria around the implant, which forms a biofilm in some patients, and can result in chronic inflammation, ultimately leading to a proliferation of lymphocytes. Less accepted theories are that textured implants create greater inflammation because of chronic mechanical irritation, and another postulates that microscopic shedding of silicone from the textured wall induces inflammation.
Q: Is it a problem with Saline or Silicone implants?
A: Of the 457 unique cases of BIA-ALCL (FDA 2-2019) implants are both silicone and saline. It appears to purely be related to the surface of the implant and not to what the implant is filled with.
Q: How does this impact those with breast implants?
A: ASAPS and ASERF emphasize that the most important issue for women with breast implants is to screen for breast cancer with self-exam, a regular physician exam, and mammography/ultrasound/MRI as recommended by their physician. Regardless of BIA-ALCL, all women should see their plastic surgeon immediately if they note a change to the size, feel, or shape of their breasts.
Q: What about those considering breast implants?
A: Patients considering textured breast implants should discuss this issue with their plastic surgeon. Since our knowledge of this condition is continuing to evolve, thanks in large part to ASERF-sponsored research, patients should check http://www.surgery.org and the FDA website for any updates.
Q: What if a doctor is recommending textured implants to a patient?
A: The choice of implant type is ultimately a decision between an educated patient and her board-certified plastic surgeon. There may be certain circumstances where a textured implant is recommended for particular patients.
All patients should have a detailed conversation with their surgeon about the risks associated with textured implants, beyond what is published online or in pamphlets. Ultimately, there are instances where textured implants are the best choice for them.
Q: How is BIA-ALCL diagnosed?
A: If a woman develops swelling in an augmented breast, she should undergo an ultrasound scan. If fluid is detected, it should be drained and tested for:
- Cytology 2. CD30
CD30 immunohistochemistry is not diagnostic for BIA-ALCL; however, it is a marker for activated T-Cells. If a patient’s seroma is CD30 positive, and the cytology is negative, this likely represents a precursor to BIA-ALCL, and should be treated with total capsulectomy. If the seroma test is CD30 negative with negative cytology, then it should be treated as a benign seroma using the individual surgeon’s protocol.
The majority of seromas seen clinically are benign seromas and not BIA-ALCL.
Management of all seromas should be by a board-certified plastic surgeon. Mammograms are not useful in diagnosing BIA-ALCL. In confirmed cases PET or MRI/CT scans may be used to help stage the disease.
If a patient wants to have their textured implants removed and replaced, the options are:
- Exchange to smooth implants
- Exchange to smooth implants with a capsulectomy
Q. How is BIA-ALCL treated and what is the prognosis?
A. Current recommendations for the treatment of BIA-ALCL call for bilateral capsulectomy (removing all the scar tissue) and removal of the old breast implants. This is a very common procedure performed by plastic surgeons, identical to what is done when an implant has ruptured or capsular contracture has developed. Smooth implants can be put back in or the patient can choose not to have implants. In all early stage cases, the disease has been fully resolved by this surgery alone. The majority of patients require no additional treatment. However, if the disease has spread to lymph nodes or grown into the adjacent tissues, chemotherapy and radiation may be necessary. These are very serious treatments with significant side effects.
Q: Are some patients at greater risk than others?
A: The rates of BIA-ALCL seem to have different rates throughout the world. This may be due to different reporting and registries, but there is likely to be a genetic predisposition that is not yet fully understood. For instance, as of this time there are very few cases in Asian patients. The risk is only with textured implants and not smooth implants; the rate is no different between silicone and saline; it occurs in both cosmetic and reconstructive patients. There is no test to determine whether one textured implant patient is at any more risk of developing this disorder than any other patients.
Q: Should patients have their implants removed because of BIA-ALCL?
A: For textured implant patients, neither the FDA nor any plastic surgery society currently recommends that women should preventatively remove textured breast implants to prevent BIA- ALCL. However, there are women who have been concerned enough about BIA-ALCL and have chosen to have their implants removed. There are some women who were already considering a breast implant revision, and the BIA-ALCL issue gave them one more reason to decide to proceed.
Breast implant patients should have ongoing follow up. Current FDA recommendations and ASAPS recommendations indicate that patients with textured implants with no issues should not do anything and implant removal is not recommended.
Q: Should women with breast implants be screened for BIA-ALCL?
A: There is no blood test to specifically screen for BIA-ALCL. The expert opinion is that asymptomatic women without breast changes do not require more than routine mammograms and breast exams. But if a patient experiences a change in her breasts – especially if there is swelling or a lump – she should undergo immediate examination, imaging, and consultation with a plastic surgeon. If there is fluid around the implant the fluid should be aspirated under ultrasound guidance and sent for analysis.
Q: What causes BIA-ALCL?
A: ASAPS, ASERF, the FDA, and the implant manufacturers are intensely studying BIA-ALCL. To date, no specific causal factors have been identified. Implant texturing, bacteriologic contamination, and genetic factors have been implicated and are undergoing further study.
The best theory today is that a combination of four factors are required for the development of BIA-ALCL:
- Textured implants (surface area to sequester bacteria)
- Chronic bacterial-inflammation
- Genetic predisposition
The source of the chronic inflammation is thought to be bacteria that have been identified around the implants in affected breasts. Evidence is accumulating that a long-term inflammatory response to the presence of these bacteria is one of the factors that may cause BIA-ALCL. Research is ongoing and cases are being monitored.
Genetic factors may play a role. Some geographic areas have reported very few cases. Ongoing data collection worldwide will help to determine whether or not there are any genetic propensities for this disease.
Q: Does ASAPS recommend against the use of textured implants?
A: The available data does not support discontinuance of textured implants, however Drs. Creasman and Hwang have decided against further use of them as of the spring of 2019.
Q. What is the recommended clinical response to a patient presenting with symptoms that could be attributable to ALCL?
A. Detailed information can be found on the ASAPS website at:http://www.surgery.org/professionals
Q: Where can I find more information on BIA-ALCL?
A: Additional information and resources on BIA-ALCL are available online at https://www.surgery.org/media/resources
Q: Is there any assistance available to the patient?
A: The Mollenkopf Aesthetic Breast Reconstruction Fund and the BIA-ALCL Patient Assistance Fund can offer financial assistance to patients. Additionally, Sientra offers to cover lab testing for any seromas associated with their implants.
- The Mollenkopf Aesthetic Breast Reconstruction Fund: http://www.aserf.org/attachments/223_mollenkopf-grant-request-form.pdf
- The BIA-ALCL Patient Assistance Fund:http://www.aserf.org/images/documents/bia-alcl-patient-fund-grant-request-form.pdf
- Sientra: http://sientra.com/Content/pdfs/LGL-0006%20R2-Sientra%20Warranty%20Terms%20and%20Conditions.pdf
The Mollenkopf Aesthetic Breast Reconstruction Fund The Aesthetic Surgery Education and Research Foundation (ASERF) is pleased to announce available funding for breast reconstruction patients. The Mollenkopf Aesthetic Breast Reconstruction Fund provides grants to ASERF/ASAPS member surgeons, to financially assist patients in completing their aesthetic breast reconstruction journeys. These funds are intended to help underinsured or uninsured patients nationwide cover the associated costs with breast reconstruction. The goal of this fund is to provide women with limited financial means the opportunity to achieve the best possible aesthetic breast reconstruction result. In particular, the grant is focused on women who need a final surgery or revisional surgery to complete their aesthetic reconstruction. The goal is for ASERF/ASAPS members to help women feel good about themselves after their reconstruction and aid them in returning “back to me.”
The American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS), in conjunction with the Aesthetic Surgery Education and Research Foundation (ASERF) and the Plastic Surgery Foundation (PSF), are pleased to announce funding for patients diagnosed with breast implant associated anaplastic large cell lymphoma (BIA-ALCL). These funds are intended to help underinsured or uninsured patients who are seeking surgical treatment of BIA-ALCL, total capsulectomy and explantation, and excision of associated mass with biopsy of suspicious node(s) and implant-based reconstruction, if indicated. The goal of this Fund is for ASAPS, ASPS, ASERF, and PSF members to help patients obtain treatment when insurance limitations would have otherwise restricted their ability to do so. The Fund is made possible by generous contributions from Allergan, Mentor Worldwide, LLC and Sientra, Inc.
The Sientra Platinum20TM Product Replacement and Limited Warranty Program for Sientra OpusTM Silicone Gel Breast Implants (Smooth and Textured Surface) offers assistance with patients presenting with late-forming seromas.
Q: What research is being conducted?
A: ASERF is currently funding two BIA-ALCL studies on the Pathogenesis of BIA-ALCL and Genomic Profiling to Understand the Pathogenesis of BIA-ALCL.
ASERF is sponsoring leading, cutting edge research on BIA-ALCL to better define the disease and improve diagnosis and outcome. More information can be found on the ASERF website: www.aserf.org
If you haven’t donated to ASERF, here’s the link: http://www.aserf.org/donor-benefits/make-a-difference
Q: What is “Breast Implant Illness” (BII)
A: There are women with breast implants who self-identify and present with various systemic symptoms and believe that these are related to their breast implants. They refer to these symptoms as “Breast Implant Illness” (BII).
BII is a term used by women who have breast implants and who self-identify and describe a variety of symptoms including (but not limited to) fatigue, chest pain, hair loss, headaches, chills, photosensitivity, chronic pain, rash, body odor, anxiety, brain fog, sleep disturbance, depression, neurologic issues and hormonal issues that they feel are directly connected to their saline or silicone, textured or smooth breast implants.
The recent increase in patients reporting Breast Implant Illness symptoms appears to be related to social media. There is one Facebook group alone with more than 70,000 members, all of whom report BII symptoms. This is not to say that social media is the cause of BII however, it may account for the rapid increases in patient reporting. BII is not an official medical diagnosis.
Q: Is there a link between medical grade silicone implants and any disease?
A: Silicone is an element that exists in nature as crystalline silica, which has been shown to activate the immune system in conditions such as systemic sclerosis which has been seen in stone masons. Silicone used in breast implants is different and to date has not been proven to cause any disease. This silicone does not exist in nature, it is created by hydroxylating silica to form polydimethylsiloxane. Medical grade silicone has had antioxidants, dyes, and plasticizers removed during processing.
Q: Are there any tests that would indicate a connection between breast implants and symptoms that are being labelled Breast Implant Illness (BII)?
There is no diagnostic testing specifically for BII. This is one of the current areas of focus for the Aesthetic Surgery Education and Research Foundation, the research arm of the American Society for Aesthetic Plastic Surgery. There are tests for autoimmune diseases that can be performed to evaluate for potential causes of a patient’s symptoms. There are patients who have symptoms they attribute to Breast Implant Illness (BII) with positive immune testing and others with all laboratory tests which show no abnormalities.
Q: Is there any scientific data showing causation between implants and these symptoms or any disease entity?
A: In 1999, The Institute of Medicine Committee on the Safety of Silicone conducted an extensive review of the available literature and concluded there was no demonstrated clear link between silicone implants and any systemic illness. There have been studies of many different sizes and design to look at the safety of breast implants themselves. These have looked at specific autoimmune disorders and diseases. In aggregate, these studies show little to no links between breast implants and any disease. Studies of patients who have symptoms that they have related to their breast implants have not shown consistent laboratory abnormalities to define a distinct syndrome. To-date, there has been very little in the way of research into this entity that has been labelled BII by women with breast implants.
Q: Does implant removal improve patient’s symptoms or cure a patient who has a medically diagnosed disease entity like an autoimmune disease?
A: Various studies show different degrees of improvement in patient symptoms after removal of their breast implants, some of which are temporary, and some showing permanent resolution of symptoms. There are no studies which specifically show which symptoms may or may not improve with implant removal with or without capsulectomy.
There is no current definitive epidemiological evidence to support a direct link between breast implants and any specific disease process. However, this does not mean further research is not indicated. In rare and unusual disease processes, it can take years to come to a scientific conclusion. There are many factors that can affect the interaction between a patient and her breast implants. Further study is required to determine the best way to potentially screen patients prior to breast implant surgery and to determine which of the multitude of reported symptoms might improve with implant and capsule removal.
Q: What is being done to better understand this group of systemic symptoms being called Breast Implant Illness?
A: Because there are many women that self-identify as having BII, the Aesthetic Society and ASERF are developing a new scientific study to examine this entity. We are also providing our members with a questionnaire to use to collect a record of complaints from patients with implants, as well as one to utilize for post-explantation. We cannot yet define BII and therefore cannot say with any certainty that it exists, because we do not have any tests we can run to prove or disprove its existence. However, we can listen to and partner with our patients to determine what is the best course of action to address their complaints, be it explantation or otherwise.
Q: What can a physician do when a patient complains of BII symptoms?
A: Patients who present with concerns of Breast Implant Illness have real symptoms that often cannot be categorized into any specific known disease entity. This does not mean their symptoms are not real and they deserve a full evaluation. The various options need to be discussed and hopefully, with further research, we may be able to determine which patients may see symptom improvement or resolution with removal of their implants and which may not see any change. Treatment options include: further medical work up with or without the consultation of a rheumatologist, observation without medical work up, implant removal without capsulectomy, exchange with or without capsulectomy, removal with total capsulectomy, or removal with en bloc capsulectomy.
Q: What is the risk of developing Breast Implant Illness (BII)?
A: As there is no definitive link between the often subjective and divergent list of symptoms, and no means for testing, there is no ‘known’ risk. Many of the symptoms described by breast implant patients are experienced by the general public on a regular basis with or without implants. That isn’t to write-off a potential connection, but no connection has been established to-date. Breast implants do have known risks, including (but not limited to) BIA-ALCL: a rare spectrum of disorders that can range from a benign accumulation of fluids around the breast (seroma) to an extremely rare lymphoma. BIA-ALCL is not a cancer of the breast tissue itself and that when caught early, it is readily curable. If the disease is advanced, chemotherapy or radiation may be required.
Q: What should be done if the patient demands an “en bloc” or “total” capsulectomy with their explantation?
A: There are many medical inaccuracies perpetuated by the internet. BII patients tend to believe that a total capsulectomy is necessary to remove all causative agents and they prefer it en bloc, oftentimes without having a full understanding of what size incision is necessary for en bloc. A total capsulectomy is normally performed on patients who have a SIGNIFICANT scar capsule around the implant, and generally requires an incision as long as the width of the implant (3 to 5 times larger than the incision used to put in the implant. Even when a surgeon plans to perform a total capsulectomy, it is not always possible to remove all the capsule. Sometimes a portion of the capsule must be left behind or is disintegrated with the use of electrocautery to prevent significant damage to muscle, rib or lung. There are increased surgical risks associated with en bloc capsulectomy which requires a complete dissection of all the tissues surrounding the breast implant and, that we do not have enough collective data to guarantee any improvement in their symptoms they have labeled Breast Implant Illness.