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What Types Of Breast Implants Are Available In Beverly Hills & Los Angeles

February 11th, 2012

What Types of Breast Implants Are Available for Breast Augmentation?

There have been varying viewpoints throughout the years about the best kind of implant to use for Breast Augmentation, and health controversies about one kind of implant that dominated news reports in the 1990’s. Many women who were interested in having fuller breasts were fearful to do so because of these reports. The following describes the different kinds of implants that are available, and addresses some of the concerns regarding differences between breast implant fill material, shape, surface texture, size, manufacture, and use of implants.

Breast Implant Fill Material:

Although all breast implants do have a solid silicone shell (bag), they are filled with different substances such as:

Saline Breast Implant

While there are a number of implants available for Breast Augmentation, currently the most commonly used is the saline breast implant.

The saline implant has an exterior sack made of solid silicone, which is filled with a sterile saline solution — like the salt-water solution that is administered for intravenous fluids. One of the advantages of this solution is its safety. Should the implant for some reason leak, the saline just gets absorbed by your body, as would the intravenous fluids used during, and after surgery. Yet another advantage of the saline implants is a very low infection rate, which is usually less than one to two percent.

Another advantage of the saline implant is that it is filled with fluid after being inserted in the breast, therefore requiring only a small incision. This is in contrast to silicone implants which are pre-filled. Also, because saline implants are filled after insertion, their final volume can be adjusted making it easier to correct for existing breast asymmetry.

Unlike other types of implants such as silicone implants, there are not restrictions on the use of saline breast implants; and women do not need to enter any specific national breast study to be eligible for their implantation, as they do for the implantation of Silicone Implants.

Widespread media reports that saline-filled implants can contract fungal contamination were discredited when it was learned that the Canadian laboratory that released this finding relied heavily on implants that had been mailed. As such, there was no guarantee of sterility in the transport of these implants.

There are two main disadvantages of saline breast implants, when compared to those filled with silicone. Because of the liquid nature of saline, saline filled implants tend to have a higher incidence of rippling, or the ability to be felt. Although rippling occurs in all saline implants, filling them according to the manufacturer’s recommendations, submuscular placement of implants, and the existence of thicker breast skin and tissue minimizes a person’s ability to see or feel rippling of saline implants. Because silicone gel has a thicker consistency, it tends to ripple much less, but sometimes happens nonetheless.

The second potential disadvantage of saline implants compared to silicone breast implants is the difference in how they feel to the touch. Outside of the body, silicone implants have a more natural consistency. In reality, this difference becomes less noticeable when implants are felt underneath the breast and muscle tissue.

Silicone Breast Implants

These are implants that are filled with a silicone gel. More than 1.5 million American women currently have silicone breast implants. Some people feel that the silicone implant results in a more natural appearing breast. However, about 15 years ago, the safety of these implants was questioned in numerous media reports, and through the filing of numerous lawsuits again the implant manufacturers. Numerous afflictions, including autoimmune diseases and hardening of the breasts, were attributed to the leakage of silicone into the bodies of women who had these implants.

The facts of the matter about silicone breast implants have been published by the Food and Drug Administration FDA ([http://www.fda.gov/fdac/features/2004/504_implants.html]):
“In January 1992, the FDA called for a voluntary moratorium–a delay on the use of these implants–until new safety information could be thoroughly reviewed. The moratorium was not intended to “ban” the implants, but instead to allow time to review the new safety information.

In April 1992, the agency decided that no PMA yet submitted contained sufficient safety and effectiveness data to support approval. However, access to these silicone gel-filled breast implants would continue for women enrolled in certain clinical studies. In the years that followed that decision, thousands of women filed lawsuits against the manufacturers of silicone gel-filled implants, claiming the devices had caused serious ailments, such as connective tissue diseases, neurological diseases, and cancer.

Consumer groups repeatedly filed petitions urging more studies on the implants. But many women said they were pleased with their implants, including cancer patients who had pleaded for the opportunity to choose silicone gel-filled implants for reconstruction. In January 2004–contrary to the recommendation of the agency’s advisory panel–the FDA determined that the new silicone gel-filled breast implant PMA was “not approvable” at that time. This meant that the implants were not approved for marketing pending additional information, but that women would continue to have limited access to them by enrolling in clinical studies”.

Therefore, at this point only women who are enrolled in long-term clinical studies are allowed to have silicone breast implants. To be considered for these studies, a woman must need implants for breast reconstruction, for repair of breast asymmetry or ptosis, or to have been among those that have developed severe rippling with saline implants. Those who have Lupus, Scleroderma, autoimmune diseases, or diseases that hinder wound healing are excluded from the study.

The main disadvantage of silicone breast implants is that their rupture is less easily detected than with the rupture of saline implants. When a saline implant ruptures, the saline gets absorbed by the body, making the breast go flat, which can be easily recognized by a woman. On the other hand, because silicone gel mostly stays within the breast tissue and does not get absorbed, there is usually no noted reduction in breast size after rupture of silicone implants. Tools to detect rupture of silicone implants include Mammograms and Magnetic Resonance Imaging (MRI). Also, the clean up and complete removal of the leaked silicone gel is difficult. Finally, although there are several studies that attest to the safety of silicone, the controversy about the safety of silicone implants remains.

Cohesive Gel Implants

Cohesive gel implants are silicone implants that are filled with a thicker silicone gel that holds its shape and form like a “gummy bear”. If you cut into a standard gel implant, the liquid silicone gel escapes from the implant shell. In contrast, when you cut into a cohesive gel implant, the implant itself maintains its shape and integrity. These shaped implants are designed with a focus upon a natural look, rather than for enlargement. Furthermore, gummy bear implants maintain their shape in an upright position that decreases the incidence of folding of the implant shell or rippling. If a cohesive gel implant ruptures, it maintains both its shape and integrity.

One disadvantage of cohesive gel implants is that they require a slightly larger incision for insertion. Because of this, insertion is usually performed through an incision in the fold under the breast, or occasionally through an incision around the areola. Cohesive gel implants are very difficult to insert through an incision in the armpit. Finally, gummy bear implants were approved in late 2006 by the FDA for use in the United States, but their use is limited to certain age, and patient require strict follow-up with MRI to look for silent rupture

You can learn more about your options about “new gel implants” by visiting the Allergan’s web site: [http://www.breastimplantstoday.com/]

PIP Implants

PIP implants are breast implants manufactured in France by Poly Implant Prostheses, and, until recently, imported by PIP/USA. PIP implants are saline but, unlike other saline implants, they are pre-filled. They are not currently approved by the FDA for use in the United States.

Soybean oil-filled Implants
Soy oil-filled implants provide a material less dense than silicone gel, or saline solution, to allow for better visualization of mammograms in the presence of implants. The goal was also to achieve a material of similar safety to saline to allow clearing once the implants eventually fail and leak. These implants are not approved by the FDA for use in the United States.

Expandable Implants

The Spectrum implants introduced by Mentor Corporation are expandable and can be filled anywhere from 25cc to 140cc depending on the initial size of the implant itself. They come with a small remote port that is placed over the outer chest rib cage. They can be filled over weeks to months to let the patient decide exactly on the size. The advantages are the flexibility and range of fill size and the ability to change it after surgery. The disadvantages are that it requires a second surgery to remove the port from the chest wall. There is also a higher infection rate with a remote port and that these implants are costlier than standard implants.

Do Implants Come in Different Shapes?

Yes. There are various shapes to implants – including Round, Teardrop — or “Anatomic” as well as a variety of Implant Profiles.

As a general rule, Round implants are wider, provide greater cleavage, and fill in the upper portion of the breast. However, the Teardrop or “Anatomic” implants might be best for women who are seeking fullness mostly in the lower breast. Although Teardrop, or Anatomical implants, were previously more popular, several studies have demonstrated that when a woman is standing, a Round implant takes on a Teardrop shape. The main disadvantage of Teardrop implants is that they do not emphasize the cleavage; and because they have a long shape, if they rotate and tilt onto their side, they can appear odd, or unattractive.

Recently, several manufacturers have introduced a variety of implant profiles from low to high profile. While round profile implants are usually wider and flatter, high profile implants are narrower and taller, resulting in a more pronounced looking breast.

Do Implants Have Different Surface Consistencies?

Yes. A woman can choose between Textured implants, or Smooth implants. Textured implants have a rougher surface. The textured implant’s primary advantage is that it has a much lower incidence of Capsular Contracture, or hardening of the breast capsule. When implants are placed over the muscle, the incidence of Capsular Contracture with smooth implants is approximately thirty percent compared to seven percent for textured. The incidence of Capsular Contracture becomes the same (seven percent) when either implant is placed under the muscle. Some surgeons feel that textured implants are more palpable and do ripple more, but the differences are not documented in large clinical studies. Considering this information, Smooth Implants are preferable, unless the patient has had Capsular Contracture in the past.

Implant Manufacturers & Warranties

There are only two FDA-approved implant manufacturers in the United States:
Inamed Corporation, which is now a subsidiary of the Allergan Corporation, offers a lifetime warranty replacement of all implants as well as $1,200 towards the cost of replacement of deflated implants for 10 years.

Mentor Corporation offers the same implant replacement policy and 5 years warranty for replacement cost. Mentor does offer an extended ten-year warranty for an additional fee.

Implant size

Both implant manufacturers have implants from 125cc to 850cc volume. Larger implants are not currently being manufactured by either company. The specific volume or size of the implant does not guarantee a bra size; as final breast size also depends on the original size and shape of the breast.

Implant use

Although the implants that we have discussed are usually for cosmetic Breast Augmentation, they are also used for breast reconstruction after the post-mastectomy chest wall skin has been stretched out to several sizes larger that the intended breast sizes, with a breast implant tissue expander.

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Silicone Breast Implant Use Is Now Approved By FDA

February 7th, 2012

The November 17th 2006 Food and Drug Administration’s (FDA) approval of the use of Mentor and Allergan (Inamed Corporation) silicone breast implants in the United States has raised many questions among women in Southern California, especially those in Los Angeles and Beverly Hills.

Prospective Los Angeles breast augmentation patients want to know if they can now receive silicone gel-filled breast implants, and if so, what types of silicone breast implants are available? And what are the potential adverse effects or concerns?

Candidates for Silicone Breast Implants

o Only women of 22 years of age and older can have silicone breast implants for breast augmentation or enlargement.

o Women of all ages can now qualify to have silicone implants for breast reconstruction.

Contraindications for Use of Silicone Breast Implants

Breast implant surgery should not be performed on:

o Women with active infection anywhere in their body

o Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions

o Women who are currently pregnant or nursing

You should also know that silicone gel-filled breast implants have not been clinically tested on women with:

o Autoimmune diseases such as lupus or scleroderma

o Conditions that could interfere with wound healing and blood clotting

o A weakened immune system (such as women receiving immunosuppressive therapy)

o Reduced blood supply to the breast tissue

o Radiation to the breast following implantation

o Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders (Please discuss any history of mental health disorders prior to surgery)
Differences in the Use of Saline & Silicone Breast Implants

Unlike saline breast implants, which are filled with saline after insertion in the body, the silicone breast implants are pre-filled with silicone. Therefore, silicone breast implants, especially the cohesive gel, memory gel, “Gummy Bear,” and the contour profile gel implants, require a larger incision for the insertion of the implant. In fact, the FDA does not allow the use of the periumbilical approach (TUBA) for the insertion of silicone implants, because excessive squeezing or manipulation during insertion can damage the silicone gel-filled breast implants.

What are some of the important factors you should consider when deciding whether or not to get silicone gel-filled breast implants?

o Breast implants do not last forever. If you decide to get breast implants, you will likely need additional surgeries on your breasts over your lifetime due to complications or unsatisfactory cosmetic outcomes.

o Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implants removed and not replaced; your breasts will not change back to the way they looked before your implant surgery. You may have permanent dimpling, puckering, wrinkling, or other cosmetic changes.

o When you have your implants replaced (a revision), your risk of complications increases compared to your primary (first) surgery.

o Routine mammograms to screen for breast cancer will be more difficult with breast implants.

o Breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.

o If your silicone gel-filled breast implant ruptures, it is likely that neither you nor your doctor will know. This is known as a silent rupture. This is why an MRI is recommended at three years after implantation and then every two years thereafter to screen for rupture. However, sometimes there are symptoms. These include hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, and pain, tingling, swelling, numbness, burning, or hardening of the breast.

o Over your lifetime, the cost of MRI screening may exceed the cost of your initial surgery. The MRI screening cost may not be covered by medical insurance.

o All silicone breast implants “bleed” or leak a very minute amount of silicone. However, worldwide studies have not linked silicone bleed to any illness.

What are the different types of silicone breast implants available?

Both Mentor and Allergan manufacture a variety of silicone breast implants. Mentor produces silicone implants of different firmness depending on the degree of silicone cohesiveness. The so-called “gummy bear” implants are the more cohesive silicone gel-filled breast implants made of firmer silicone gel filler to help maintain the shape of the implant.

Potential Complications of Silicone Gel-filled Breast Implants

In the Mentor and Allergan core studies, the most frequent complication was re-operation (additional surgery) – 25-35 percent. Capsular contracture or hardening of the breast implants (13-17 percent) was another frequent complication. Additional common complications include implant removal (7-10 percent), breast pain (7-8 percent), nipple sensation changes (1.5 percent), rupture (2.7- 4 percent), and asymmetry (3-5 percent). The complication rates were typically higher for revision surgery than for primary (first-time) implants.

Decision to Have Silicone Breast Implants

As a plastic surgeon, I often get asked if I would recommend silicone breast implants to my wife. Frankly, many national studies have established the safety of silicone breast implants and have found no link to the development of autoimmune disease, cancer, etc. Nevertheless, there are still unanswered questions about the long-term results (per FDA). Those who choose to have silicone implants enroll in the 10-year, post-approval study so that more light can be shed on the long-term effects of these medical devices.

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Safety Of Silicone Gel Breast Implants Versus Saline Breast Implants For Breast Augmentation

January 22nd, 2012

Many people have written me about the safety of silicone gel breast implants and how to decide which type of implant to choose. I am reprinting here one response which I think presents helpful guidelines for women considering breast augmentation or enlargement, or Breast Lift, and trying to decide which breast implant to choose, saline or silicone gel.

There are many factors to think about when deciding whether to have breast enlargement or augmentation. The newer silicone gel breast implants have been approved by the FDA and have been available since January 2007. Many women share your concern about the safety of these new implants for breast augmentation.

My first comment is that breast augmentation or enlargement, if done on an appropriate candidate by an experienced board certified plastic surgeon should produce an equally pleasing and successful aesthetic or cosmetic result with either type of implant.

The main difference in the result of breast augmentation with saline breast implants from that with silicone gel breast implants is the feel of the implant. If there are no complications such as hardening of the implant, and the result of the surgery is satisfactory, then a silicone gel implant will feel more natural than a saline implant.

There are many factors which contribute to the different feel of the Saline implant and most of them can be predicted or managed. In very thin women with very little breast tissue to cover the implant, the saline will be more palpable. If a capsule forms around the saline implant, it will be more palpable. If the surgeon does not over fill the saline implant, palpable folds can develop.

Placing the saline breast implant beneath the chest muscle helps to prevent palpable folds in the implant and over filling the implant helps prevent folds. Meticulous surgical technique and avoidance of bleeding during surgery also helps avoid the capsule which is scar tissue which makes the implant hard.

A silicone gel breast implant which has been placed under the breast or muscle, with meticulous technique and which does not form a capsule or hardening does result in the most natural feeling breast. A “perfect result” with a silicone gel implant does feel better than a “perfect result” with a saline implant, but visually, the way they look, is about the same, in my opinion.

There are however disadvantages to silicone gel implant breast augmentation or enlargement. The new FDA guidelines require that you have frequent MRI exams to check for rupture-this is expensive. The risk of capsular contraction of the breast implant is about the same with the newer gel implants as with the saline implant-13-15%. In addition if the implant does rupture and need to be replaced, the surgery to replace a silicone gel breast implant is more complex than that for a ruptured saline breast implant.

Most women in my practice find the decision an easy one. Many patients are very health conscious and only concerned with safety, want the least risk, don’t want to bother with MRI’s, and are most concerned with how the breast looks and don’t care about a subtle difference in feel and want the least risk of firmness or capsular contraction of the breast implant. These patients are usually married, have children, and are in their late 20′s to early 40′s. They typically choose saline breast augmentation.

By far the largest group who select silicone gel breast augmentation are patients who have had a previous breast augmentation, usually with saline implants, and want a more natural feeling breast implant and choose to have replacement with silicone gel implants. The other large group of patients selecting sgel breast implants is younger women, single with no children, who have read a lot about breast augmentation and want the most natural feeling implant.

It comes down to your priorities and your situation. Silicone gel breast implants are safe and if there are no complications, they produce a beautiful natural feeling result.

If you want the peace of mind of not worrying about firmness and having to have MRI’s and worrying about the possibility of rupture and you are willing to accept the fact that the implant will be subtly palpable and MAY (many do not form folds) form palpable folds that likely only you will notice, the saline breast implants are a better choice for you.

If you want the best feeling or most natural feeling implant then silicone gel breast implant is the best choice.

The most important thing is for you to find an experienced board certified plastic surgeon who has done many breast augmentation operations and can give you an honest opinion.

In my opinion the most important factor in achieving a good result with either type of breast implant is the skill and experience of the surgeon. This operation needs to be done meticulously and carefully, and not all surgeons take this approach.

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