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Sientra: The New FDA-Approved Shaped Gel Breast Implant

· Breast, Breast Augmentation, Breast Implants, Choosing the Best, Safety · No Comments

Breast augmentation surgery is the most commonly performed surgical procedure in plastic surgery. Following the breast implant lawsuit crisis of the early 1990’s most silicone gel manufacturers fled the U.S. market. Only two companies, Allergan (formerly McGhan/Inamed) and Mentor/J&J, remained and have dominated the market for the past 20 years. One consequence of this implant duopoly is that the cost of breast implants increased from hundreds to thousands of dollars since the 1980’s.

 

Earlier this year the U.S. F.D.A. which regulates medical devices approved a third breast implant manufacturer. Santa Barbara based Sientra was approved to offer silicone gel prostheses for sale in the U.S.  Allergan and Mentor are also based in Santa Barbara, leading to the affectionate term of “Silicone Alley” for the Southern California region.

 

Dozens of breast implant companies exist throughout the world. Many of these brands are sold in Latin America. Sientra’s parent manufacturer has sold implants internationally, but of course U.S. approval is a highly coveted achievement.

 

A Good Thing…and a New Thing

 

The arrival of a third player to the U.S. breast implant market is expected to be a good thing for American women. In addition to providing greater competition, Sientra offers a unique line of shaped gel implants. These “teardrop” or “anatomical” breast prostheses are commonly used in Europe and Latin America. A saline-water filled version has been available for years in the U.S. However, Sientra is the only manufacturer granted F.D.A approval for the gel filled type.

Shaped implants offer greater options for both cosmetic and reconstructive breast surgery. The prostheses come in a variety of shapes, sizes, base diameters and projections giving both the patient and surgeon greater versatility in body contouring.

 

The augmentation procedure using shaped implants is different from the traditional round prosthesis insertion. Therefore it is advisable that patients choosing these implants consult with experienced breast plastic surgeons. As a corporate philosophy, Sientra will only sell and warranty implants placed by plastic surgeons recognized by the American Board of Plastic Surgery.

 

Editor’s Note: Dr. Perez can be seen on ABC News in Miami discussing the Sientra implant at:

www.Youtube.com/user/PerezPlasticSurgery

 

 

About the Author:

 

Dr. Perez is a member of the NOVO National Council of Leaders in Breast Aesthetics. He has served as a consultant for both Mentor (J&J) and Inamed (Allergan). Dr. Perez has lectured internationally on the subject of breast surgery and has been selected among the Castle Connolly (U.S. News & World Report) America’s Top Doctors. More information is available at

May is Mommy Makeover Month (Original Article)

· Abdominoplasty/Tummy Tuck, Body Contouring, Breast, Breast Augmentation, Breast Implants, Liposuction · No Comments

May is the month we dedicate to celebrate motherhood. It’s only fitting, therefore, that we also recognize the changes that motherhood brings.

Of course, becoming a mother alters the life of a woman in many ways, often running the gamut of emotional experiences. There are also changes to a woman’s body that accompany growing, carrying and bearing a child.

Pregnancy, and the weight gain that occur, create growth, not only of the baby, but also of the mom. Among the structures that grow to accommodate the new addition is mom’s belly skin. Sometimes the skin has difficulty expanding evenly so it cracks in areas. These cracks in the skin are what we identify as stretch marks.

Labor and delivery also create changes in the woman’s pelvis, allowing the hips to relax and widen during the birthing process. Multiple pregnancies multiply this effect on the woman’s body. These permanent changes are, however, well compensated by the joys of motherhood

The other parts of the woman’s body greatly affected by pregnancy are the breasts. The breasts grow and engorge in preparation for feeding the infant. Many women like the appearance of their breasts during pregnancy because the breasts become full and robust. Often women are disappointed after pregnancy when the breasts lose their fullness and begin to drift downward.

The good news is that many of the undesirable effects on the woman’s body from pregnancy can often be minimized before, or improved afterwards, through good perinatal care, as well as, the judicious and timely use of plastic surgery.

 

Let’s Start at the Top

            The breasts typically lose their fullness and descend to a lower position after pregnancy. Sometimes the areolae also stretch. The reasons for these changes are simple; gravity and skin tone.

The surgical treatment of post-pregnancy breast changes depends upon the condition. Lack of fullness requires placement of implants to restore volume. Nowadays many implant choices are available. Women who choose to breast feed should defer breast augmentation until the breasts revert back to their dry, pre-pregnancy state, usually 1-2 months after cessation of feeding.

Breast droopiness requires a lift procedure. Lift techniques vary but typically involve a greater degree of scarring than simple breast augmentation. Patients need to be ok with these scars and should have a thorough consultation to review them prior to surgery. Areolae can also be made smaller at the same time. Sometimes patients can benefit from both a breast lift and augmentation to restore position and fullness.

 

Then There’s the Baby Belly

            The abdomen does the heavy lifting in pregnancy. It’s no surprise therefore, that, after pregnancy, skin redundancy and stretch marks can remain. Another interesting effect of pregnancy is a separation of the paired rectus abdominus (i.e sit-up) muscles. The result is a gap between the muscles resembling a hernia. It is because of this anatomical separation of the muscles that abdominal exercises after pregnancy, such as sit-ups, although beneficial, are of limited value.

In cases of loose abdominal skin, stretch marks, and muscle separtation, the procedure of choice is an abdominoplasty, also known as a tummy tuck. Like the breast lift, tummy tuck surgery requires scars that need to be accepted by the patient. The tradeoff, however, is substantial removal of excess skin and stretch marks, as well as repositioning of the muscles. The result is a dramatic tightening of the belly with a very high degree of satisfaction. Tummy tuck patients are among the happiest in my practice.

Since both the breasts and the belly are affected by pregnancy, women often choose a combination of procedures. Sometimes even other areas, such as the love handles or the thighs also become part of the mommy makeover.

Combination procedures require additional safety considerations with respect to the operating facility and anesthesia. As with all plastic surgery a thorough and honest consultation with an experienced surgeon is key to a happy mommy. Happy Mother’s Day!

 

 

About the Author:

 

Jorge A. Perez, M.D., F.A.C.S. is a board certified plastic surgeon in Ft. Lauderdale. He is a member of the NOVO National Council of Leaders in Breast Aesthetics. He has served as a consultant for both Mentor (J&J) and Inamed (Allergan), leading breast implant manufacturers.

He has lectured internationally on the subject of breast surgery and body contouring and has been selected among the Castle Connolly (U.S. News & World Report) America’s Top Doctors. More information is available at www.PerezPlasticSurgery.com or Perez9800@Gmail.com or call (954) 351-2200.

Breast Implants: Is it time for a Change? (Original Article)

· Breast · No Comments

Breast augmentation continues to be the most common cosmetic procedure performed by plastic surgeons. Although breast implants have been popularized by celebrities such as Pamela Anderson and Britney Spears, the history of these controversial devices began five decades ago.

Initially women’s breasts were enlarged using surgically placed sponges. The procedure was crude and fraught with complications. Modern augmentation took hold in the 1970’s with the use of silicone gel implants. The benefits of breast implants were even touted in the song “Dance 10, Looks 3”from the hit Broadway musical “A Chorus Line”.

The Controversy Years

 

            The 1980’s brought the largest surge in breast augmentation procedures. A variety of implant types were available from multiple manufacturers. Most devices were filled with silicone gel or saline, salt water solutions. In the late 1980’s and early 90’s reports of arthritic-type diseases associated began to surface. Citing a lack of safety data for the implant devices, the Food and Drug Administration withdrew silicone gel implants from theU.S.market. Most of the existing companies left the implant market, leaving only twoU.S.manufacturers. California-based Mentor Medical and McGhan Medical (later Inamed/Allergan) remained as the onlyU.S.producers of breast implants.

Limitations were placed in 1991 on the availability of silicone gel implants. Saline filled became the only devices available for primary cosmetic breast augmentation. With rare exception, in theU.S., gel devices were approved only for reconstruction following mastectomy. However, throughout the 1990’s, the implants continued to be the most popular devices for augmentation outside theU.S.andCanada. Ironically, the cosmetic gel implants produced by the U.S. manufacturers were available only for export to women outside the U.S.

Saline Implants Rule

The 1990’s and first half of this decade were defined by a growth in breast augmentation surgery using saline implants. They are silicone rubber bags filled with a salt water solution. Vocal celebrities, reality TV shows and a growing image-conscious society combined for a boom in plastic surgery procedures, led by saline implants.

The implant is placed empty into the pocket and folded like a taco, so the scar is only slightly larger than an inch. The smaller scars allow for greater flexibility, including the incision around the areola or even the belly button. It is filled to the actual size with the saline solution on the operating table. More water can be added to one side, if necessary, to correct a size disparity. The implants can be placed in front, or behind the pectoralis chest muscle.

The implants are not without occasional problems, though. A thick scar tissue shell, termed a capsular contracture, may occur causing hardness or distortion to the breast. Deflation of the implant with loss of the water solution is also possible. Both of these problems may require additional surgery. Patients sometimes can feel, or even see, the rippling edges of the implant. In some cases this is very bothersome. In addition, in patients with very large implant pockets the cleavage can be unpleasantly wide. Despite the occasional complications, however, the procedure carries a very high degree of satisfaction.

They’re Baaaack…

            Saline implants ruled in theU.S.until late in 2006, when the F.D.A. approved silicone gel implants for primary cosmetic augmentation. The twoU.S.manufacturers partnered with selected plastic surgeons with expertise in breast augmentation. The National Council of Leaders in Breast Aesthetics was formed to provide feedback on the new prostheses.

The new gel implants, sold internationally for years, are different from the prostheses of the 1980’s. The gel is not as liquid as before making leakage less problematic. The new implants are often called “gummy bears” because of their cohesive, firmer filling. The new gels are the most natural feeling implants to date. They are also lighter than the saline implants, a feature especially valuable for women with looser breast skin.

The gels have some disadvantages too, however. The implant is prefilled and sealed so the incision required is slightly larger and adjustment of minor asymmetries is not possible. In addition, the F.D.A. attached a few strings to their approval. Patients must be 22 years old and M.R.I. examination of the breasts is recommended to detect leaks. The new gel implants are also more expensive than saline.

 

What’s Next

            The past two years have seen a transition from saline implants to the new silicone gels. In our practice most new patients are choosing gel implants because of their softer, more natural feel and lighter weight. In addition, many patients with existing saline implants, especially those with hardness, rippling or deflation, are opting for a change to silicone. In cases of malposition or unpleasantly wide cleavage, reshaping the implant pocket is also possible.

The newest breast implant on the horizon is a combination of silicone gel with an inner saline chamber. This exciting new prosthesis allows for the soft feel of silicone with the adjustability of saline. The water can even be added weeks after the surgery allowing the patient to choose her final size. Although it is produced by a U.S. manufacturer, the implants are not yet available here.

Finally, women considering breast augmentation should have multiple consultations with board certified plastic surgeons experienced in the procedure.

 

About the Author:

 

Jorge A. Perez, M.D., F.A.C.S. is a member of the NOVO National Council of Leaders in Breast Aesthetics. He has served as a consultant for both Mentor (J&J) and Inamed (Allergan), leading breast implant manufacturers.

He has lectured internationally on the subject of breast surgery and has been selected among the Castle Connolly (U.S. News & World Report) America’s Top Doctors. More information is available at www.PerezPlasticSurgery.com or Perez9800@Gmail.com or call (954) 351-2200.

Natural vs. Fake: The Dilemma of Breast Implants (Original Article)

· Breast · No Comments

breast augmentation for women seeking fuller figures has been around since the 1960’s. The original operation involved the insertion of surgical sponges. It was fraught with problems.

 

The 1997 movie Breast Men is a semibiographical depiction of the pioneers of breast implants who first used silicone prostheses. Since that time implants, and the surgical procedures to insert them, have evolved in many ways. However, the original goal is still the same; achieving a natural look.

 

Although the definition of “natural” can vary significantly, I’ll try to outline the variables I work through with patients for breast augmentation. It is important that patients be informed of the various options because there are several decisions in which they should participate.

 

Size Matters

            The most common question I’m asked during breast augmentation consultation is “What would be a good size?” My first response is to remind the patient that implants are not breasts. They are basically bags of water (saline) or gel (silicone) that are placed to enhance the woman’s own breast tissue.

 

A simple formula is that the greater the patient’s own breast tissue, and the smaller the prosthesis, the more natural the result. The converse is also true: the less tissue and larger prosthesis, the less natural, or more fake the appearance.

 

Size is, by far, the most important variable in achieving a natural result. If there is any doubt just take a walk along South Beach. In my opinion, there is nothing worse than an attractive woman with distractingly large breast implants.

 

Breast size is also influenced by cultural factors. I’ve had the privilege of lecturing in many countries. When I survey plastic surgeons I find that average implant size increases from Asia to Europe to Latin America to the U.S. I tell my colleagues that here we suffer from what I call the “Pamela Anderson Syndrome”. Interestingly, surgeons everywhere, even in Vietnam, seem to be familiar with the Baywatch star.

 

The problem with choosing an implant size is that there is no precise language that the patient and doctor can speak. Women identify breast dimension by cup size of their bra. Unfortunately, as most women know, bra size can vary tremendously. In addition, implants don’t come in cup size. Manufacturers create implants in sizes based upon the volume, in cubic centimeters (cc’s) of the bags. However, the numbers (250, 300, 350…) are usually meaningless to the patient.

 

Each surgeon develops his or her own technique for choosing the right breast implant size. Sometimes patients will bring in photos or try on sample prostheses in the office. I like to ask patients what their goals are. Do they want to be understated? Proportionate to their build? Or do they plan to dance on tables? It’s not an exact formula but I perform many augmentations and this method has worked well for me over the years.

 

I also point out to patients that breast implants are not like a pair of shoes, where one size fits perfectly, but a size above or below won’t. The correct choice of implant falls into a range of potential sizes.

 

Shapes and Styles

            Breast implants come in various shapes and styles. These choices will also impact the aesthetic result of surgery. The first choice is between saline and silicone prostheses. Saline implants are silicone-shell water bags. Silicone gel implants have a filling similar to gummy bear candy. Gel implants are softer. They feel and look more natural and are lighter than the equivalent saline sizes.

 

Gel implants are the most commonly used breast prostheses throughout the world. They are more expensive that saline and have some restrictions which should be discussed at the time of consultation.

 

Saline and silicone implants come with either a smooth or textured cover and in round or teardrop shapes. The concern of the latter is that they can tilt and cause an uneven bulge.

 

Textured implant covering feels similar to Velcro. It tends to make the implant stiffer and more likely to cause unnatural rippling of the breast skin. In the U.S., the smooth, round implants are most common. However, patients should feel all the implant types at the time of consultation and then decide for themselves.

 

Surgical Technique: It’s All About the Cleavage!

There are several surgical incisions and approaches to breast augmentation surgery. The technique often will vary based upon the surgeon’s preference and experience. The patient’s goals are important here too. These choices include placement of the scar and the implant pocket. The specifics of these decisions should be discussed with the surgeon during the consultation.

 

One very important variable however, is the position of the implant pocket. All too often implants are placed too far apart and fail to close the cleavage gap. However, women certainly understand, it’s all about the cleavage!

 

Even though every woman presents with a different preoperative cleavage gap, the surgeon should focus on helping the patient achieve her personal best. With few exceptions, the gap should be narrower in almost all cases.

 

We’ve revised cases where the gap was so wide that when the patient laid down the implants would roll into the armpits. One patient even affectionately referred to herself as the “table top chest”. In my opinion, proper cleavage is second to size in achieving a natural result.

 

So what goes into a “natural” breast implant result? The answer is all of the above; size, shape, style, technique and cleavage. Obviously, these will vary by patient and her personal goals. They should all be discussed thoroughly at the time of consultation.

 

About the Author:

Dr. Perez is a member of the NOVO National Council of Leaders in Breast Aesthetics. He has served as a consultant for both Mentor (J&J) and Inamed (Allergan), leading breast implant manufacturers.

He has lectured internationally on the subject of breast surgery and has been selected among the Castle Connolly (U.S. News & World Report) America’s Top Doctors. More information is available at www.PerezPlasticSurgery.com or Perez9800@Gmail.com or call (954) 351-2200.

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