Breast Implant Safety
Breast implants have been used for about 40 years. Millions of breast implants have been placed in women in the USA alone, and millions more were used in other countries. Breast implants are, however, not guaranteed to last a lifetime, and future surgery may be required to replace one or both implants.
Fourteen years after the FDA first put a moratorium on the use of silicone gel breast implants, the FDA finally completed its study of the implants. On November 17, 2006, the FDA ruled that silicone breast implants are safe to return to the market for cosmetic procedures. FDA studies led researchers to conclude that silicone breast implants did not cause any kind of disease. Studies showed that there was no greater incidence of any type of disease in women with silicone breast implants compared to the general female population. At this point, it is fair to say that breast implants are among the most studied medical devices ever, having gone through decades of research in thousands of women.
Both saline and silicone gel breast implants are approved by the U.S. Food and Drug Administration (FDA). Approval means that an implant has been rigorously researched and tested, and reviewed by an independent panel of physicians for safety. Saline implants were initially developed as an alternative to silicone gel implants. Saline-filled implants consist of a silicone rubber shell that is filled with sterile saline (salt water) solution. The saline is the same fluid that constitutes the majority of your body water. Saline implants offer a variety of advantages over silicone ones. The primary advantage is that saline implants are adjustable; doctors can differentially fill implants to obtain near perfect symmetry. Should the implant shell ever leak, the saline implant will collapse and the saline would easily be absorbed by the body and be excreted in the urine. Women who might be concerned about silicone gel may be comforted by the fact that these implants contain salt water.
An adjustable saline implant, Spectrum® breast implant, allows adjustments to the breast volume for up to six months after your surgery. A small, removable fill tube is left temporarily attached to the breast implant after surgery. The tube is accessible to the physician by injection through the skin. In a simple office procedure, breast implant size can be varied until you have achieved the result you desire. At this point, the fill tube is removed during an office visit. One of the more difficult decisions you’ll face in breast augmentation is deciding what size breast implant fits your body best. The Spectrum® breast implant greatly simplifies this concern by giving you and your surgeon more flexibility and control over the end result of your breast enlargement procedure.
Silicone gel breast implants were the most popular type before the early 1990s. These also consist of silicone rubber on the outside, but the inside contains a semi-solid gel of silicone. Silicone is a man-made substance that has many uses. In a breast implant, it closely resembles the look and feel of natural breast tissue, so it was an obvious choice when the first implants were created. Concerns were raised in the early 1990s that patients with these silicone gel implants might develop systemic diseases (like lupus or arthritis), but several carefully conducted studies have demonstrated no difference in the incidence of these diseases in women with and without silicone gel implants. Silicone gel implants were subject to a great deal of scrutiny and research during the 1990s and 2000s. Finally, on November 17, 2007, they were again released for use in breast enhancement. If the silicone implant leaks, the gel may remain within the implant shell, or may escape into the breast implant pocket. A leaking implant filled with silicone gel may not collapse. Thus, an MRI study is recommended by the implant manufacturers to assess the condition of breast implants.
Modern silicone gel implants contain a “cohesive” type of silicone gel. Cohesive gel implants refer to a new type of implant still in developmental and testing stages. Cohesive gel implants, known as “gummy bear implants” are more solid than other silicone models, and have the feel and consistency of a gummy bear when you cut into one. The advantages of this type of breast implant are that it doesn’t leak like traditional silicone implants if ruptured. These were invented to create a longer-lasting implant that would retain an attractive and predictable shape. At present, these implants are available today only as part of an “adjunct study,” which is open to patients that have specific congenital defects or need a revision for particular reasons.
Inserting the gummy bear breast implant through the inframammary fold approach is the most popular method, since gummy bear implants require a longer incision than saline and silicone breast implants.
One downside to the silicone or cohesive breast implant is the fact that these implants can not be inserted through the belly button via a transumbilical breast augmentation (TUBA). TUBA is a popular procedure because there are no noticeable scars since the incision is hidden in the navel. This type of breast enlargement requires that an implant be folded and placed through a long hollow tube.
Smooth vs. Textured Surface Breast
Breast implants can have a smooth surface or a textured (rough) surface. As a natural reaction to any device placed in the body, a shell of scar tissue will form around the breast implant surface, creating a capsule. In some women, the capsule can tighten and squeeze the implant. This occurrence is called capsular contracture. The texturing was originally introduced in silicone gel implants to reduce the incidence of capsular contracture around the implant. This does appear to be effective when the implants are placed beneath the breast gland and over the muscle of the chest wall. Textured implants have never been shown to provide any advantage over smooth implants when placed beneath the muscle of the chest wall. Textured implants also have their own disadvantages. Textured implants have a slightly thicker and stiffer shell which translates into an implant that is more visible through the skin and is more easily felt when the breast is touched. A smooth implant will settle into the breast more quickly and easily than a textured implant, and may be less likely to show wrinkling. Because of textured implant disadvantages and because most implants are placed in a submuscular plane, the great majority of breast implants used today are of the smooth variety.
Round vs. Anatomical-Shaped Breast Implants
A specialized type of textured implant is the “Anatomical” or “Teardrop” implant. These implants are not round, and must be textured to keep them from turning the wrong way in the pocket. These implants have a width that is different from the height and may be helpful in special situations to better simulate the shape of the natural breast. However, the final shape of the breast is determined by the breast and muscle tissue, rather than the implant, which is not strong enough to hold against the force of the tissue. Anatomically-shaped implants must be placed in exactly the right position and leave less room for error. If an anatomically-shaped implant moves around, it will cause a very unnatural profile.
Low, Moderate, or High Profile Breast Implants
Until recently, most patients never discussed profile with their plastic surgeons. If you chose a certain size implant, you would receive a determined amount of forward projection from that size implant. Now, you can choose an implant size and the degree of projection. This works well for certain body types. For example, for a woman with a very narrow frame, a low or moderate profile implant may be too wide for a given volume and carry the implant too far to the cleavage and underarm. By using a high profile implant, this patient can get the larger volume that she desires. By the same token, a wide-framed patient may find that in order to adequately cover the natural diameter of their breast size, the desired implant would have far too much projection. A low or moderate profile might work better. Depending on the shape of your chest, Dr. Agha will advise you as to the best type of implant for your body.
Low, Medium, and High Profile Breast Implants
Low Profile Implants – These breast implants have less projection for a given base diameter than a moderate profile breast implant.
Moderate Profile Implants – This breast implant profile is usually used and provides a moderate degree of projection for a given base diameter.
High Profile Implants – These breast implants have more projection per measurement of base diameter than a moderate profile breast implant.
There are two manufacturers whose silicone gel breast implants have been approved by the FDA: Allergan and Mentor.
Ask Dr. Agha or his staff for a full overview of the current Mentor Advantage & Enhanced Advantage warranties or click here for a full overview of the current Mentor Advantage & Enhanced Advantage Warranties.
Choosing Proper Breast Implant Size
Choosing the right size implant is generally the most important decision that you have to make. Because of this, Dr. Agha will take several approaches to help you make the best decision based on your anatomy, personal preferences, and the appearance you wish to achieve. Dr. Agha will then examine your breast tissue and skin, and will make appropriate measurements of your breast characteristics in reference to your chest. These measurements will provide him with an idea of a suitable implant that will help you achieve the size you want post-operatively. An ideal implant will correspond to and cover the base of your breast. Thus, the diameter of your breast will provide the most important measurement and a good starting point to select your implant of choice.
Choosing an implant that is smaller than your natural breast envelope will not provide the proper cleavage and shape following the procedure. Similarly, choosing an implant that is too large for the amount of breast tissue is more likely to give you an unnatural appearance. Inappropriately large implants may be visible through your skin or the implant may be more easily felt. Also, breast implants that are excessive in size may enhance the effects of gravity on your chest, which may cause your breasts to prematurely droop or sag.
Your breast size after surgery depends on two main factors: your breast size before surgery and the volume of implant inserted. The volumes of the breast implants are measured in CCs (30 cc= 1oz). Although everyone is built differently and bras are not manufactured to a set standard, you can expect that a cup size is approximately 200cc in a person of average height and build. If you are tall or have broad shoulders, you can expect that number to be slightly higher. Similarly, if you are shorter or have a narrower chest, you can expect that number to be slightly lower. During your consultation with Dr. Agha, you will try actual implants of different sizes by placing them in your bra. This will help you make your decision about the implant size. You should make sure that your bra is not a push-up or padded bra on the day of your consultation. Although a desire for a certain cup size is helpful to Dr. Agha in guiding you in the selection of the proper implants, it is more helpful to focus on the shape and appearance that you wish to achieve. The most popular implant sizes are about 275 to 350 CCs in Dr. Agha’s practice.
Please feel free to make as many trips to the office as you need to be satisfied with your implant selection. Our goal is your happiness. Being realistic and following your doctor’s recommendations is very essential for the best result possible.
In addition to performing breast augmentation, Dr. Agha performs breast lift with implants and breast reduction. Contact his practice today at 949-537-2177 to learn about all of your procedure options.
Dr. Agha Siamak is a renowned breast surgery and body contouring provider. Over the years he has helped many breast augmentation, liposuction and tummy tuck Orange County patients look and feel their best. In addition, he performs advanced procedures such as facelift and rhinoplasty in Newport Beach. Schedule a consultation today by calling 949-537-2177.