These are some of the key findings in the new statistics from the American Society for Aesthetic Plastic Surgery (ASAPS).

Cosmetic surgical procedures increased almost 1% since 2010, while minimally invasive procedures decreased almost 2% in the same time period.

This is the 15th year the ASAPS has tracked plastic surgery. Since 1997, cosmetic procedures have increased 197% for men and women combined — and there have been some changes over the years.

“Surgery seems to be slowly coming back,” says ASAPS President Jeffrey M. Kenkel, MD. He is a professor and vice chairman of the department of plastic surgery at the University of Texas Southwestern Medical Center in Dallas.

Noninvasive procedures such as injectables do have a role, but individuals are looking for more durable results, says Kenkel.

One of the reasons that the numbers are creeping up is that people need to stay in the work force longer, which means that they must compete with their younger counterparts for the same jobs, he says.

Liposuction topped the list of most popular plastic surgeries in 2011, and injections of botulinum toxin type A (including Botox and Dysport) ranked as the top nonsurgical procedures, the new statistics show.

Top Surgical Procedures

According to the new statistics, the top five surgical procedures in 2011 were:
•Liposuction
•Breast augmentation
•Abdominoplasty (tummy tuck)
•Eyelid surgery
•Breast lift

Fully two-thirds of women opting for breast augmentation with implants chose silicone-filled breast implants in 2011. Kenkel says this shows that women and plastic surgeons are becoming more comfortable with the safety of these implants.

Due to safety concerns, there was a 14-year ban on the use of silicone breast implants. This ban was lifted in 2006. In a further nod confirming the safety of these implants, the FDA recently approved a new silicone-gel breast implant from Sientra, making it the third company to market these implants in the U.S.

Top Nonsurgical Procedures

In 2011, the top five minimally invasive procedures were:
•Botulinum toxin type A
•Hyaluronic acid-based fillers (for treatment of wrinkles)
•Laser hair removal
•Microdermabrasion
•Intense pulsed light (IPL) treatments (for treatment of skin redness and uneven skin tone)

Women had almost 8.4 million cosmetic procedures in 2011, and men had almost 800,000. The number of cosmetic procedures for men increased over 121% from 1997, which was the year that ASAPS first started tracking these statistics.

The new statistics were based on questionnaires sent to dermatologists, otolaryngologists, and plastic surgeons. More than 1,100 doctors returned the questionnaires. The final sample included responses from 420 plastic surgeons, 384 dermatologists, and 211 otolaryngologists.

Fears over the defective implants spread across the world late last year after French health authorities advised 30,000 women to have them removed because of an increased risk of rupture. Reports are now saying between 400,000 and 500,000 women in 65 countries are believed to have implants from PIP, once the world’s third-largest silicone implant producer.

Even more alarming are questions surrounding the type of silicon used in the PIP implants. PIP founder, Jean-Claude Mas, was arrested and charged in France with causing “involuntary injuries”. To cut costs, Mas was making the implants with industrial grade silicone that could cause potential health problems.

Here in the U.S., The Food and Drug Administration (FDA) found that the PIP saline implants were prone to rupturing and the devices were banned.

In other European countries, according to Patrick Malucci, MD FRCS, a breast implant expert in the U.K., government approval is easier to acquire. The CE Mark, meaning “European Conformity”, is a mandatory mark that means the product is safe and meets the European health and environmental protection legislation. It also means the product can be placed on the market for consumers.

Dr. Malucci says, “What seems to have happened with PIP, is they got their CE approval, then discarded the good silicone and replaced it with illegal non-medical grade silicone. The failure here is that once you get a CE mark, it seems that nobody else checks on you again.”

“Price is still the biggest selling point for cosmetic surgery tourism, but you may be taking unnecessary risks with products or devices that have not been proven safe and effective,” warns Dr. Glicksman.

For worried patients here in the U.S., Dr. William P. Adams Jr., a board certified plastic surgeon in Dallas who specializes in breast augmentation says, “To be clear these implants were never used in any surgeries here in the U.S. but that’s not to say some women in the U.S. don’t have them. If a woman went overseas to have the surgery they should see a board certified plastic surgeon.”

Dr. Glicksman says, “Even though there are many well qualified plastic surgeons outside of the United States, there are countries that just do not have the same level of strict consumer protection that we have here in the United States. If a woman from the U.S. travelled overseas for breast augmentation, she needs to know what type of implant she has.”

According to Glicksman, “Most patients are given an ID card after surgery that identifies the name of their surgeon and the manufacturer. If the procedure was done outside of the United States within the last 10 years, I would recommend locating all medical records, or contacting the clinic where the procedure was done.”

If you are sure that you have PIP implants, Glicksman says, then you have several choices. She states, “While the International Society of Aesthetic Plastic Surgeons (IPRAS) and the European Committee on Consumer Safety is encouraging women with PIP implants to have them removed, in some countries, the medical societies are simply recommending that women visit their plastic surgeon for a checkup.”

Glicksman states that what’s important to remember is that a physical exam alone may not be a reliable way to detect an implant rupture. She says patients who are having symptoms should also undergo radiological tests to look for implant failure.

About 14 million procedures were performed in the United States in 2011, up 5% from 2011. In addition, 5.5 million reconstructive plastic surgery procedures were performed last year, also up 5%.

“While the rate of economic recovery in the U.S. is still uncertain, 2011 proved to be a good year for plastic surgery,” said ASPS President Malcolm Z. Roth, MD, in a press release. “Consumer confidence was up, auto sales rose 10%, so it is not surprising that we would also see increased demand for plastic surgery procedures.”

In 2011, cosmetic surgical procedures increased 2%, with nearly 1.6 million procedures in 2011.

The top five surgical procedures were:

• Breast augmentation (307,000 procedures, up 4%)
• Nose reshaping (244,000 procedures, down 3%)
• Liposuction (205,000 procedures, up 1%)
• Eyelid surgery (196,000 procedures, down 6%)
• Facelift (119,000 procedures, up 5%)

This is the first time that facelifts have made the top five list since 2004, replacing tummy tucks. The rate of chin augmentation, popular with men, nearly doubled in 2011, with 21,000 procedures performed, up 71% from 2010. Lip augmentation also increased by just shy of 50%, with more than 25,000 procedures performed in 2011.

Cosmetic minimally-invasive procedures increased 6%, with nearly 12.2 million procedures in 2011. The top five minimally-invasive procedures were:

• Botulinum toxin type A (5.7 million procedures, up 5%)
• Soft tissue fillers (1.9 million procedures, up 7%)
• Chemical peel (1.1 million procedures, down 3%)
• Laser hair removal (1.1 million procedures, up 15%)
• Microdermabrasion (900,000 procedures, up 9%)

Soft tissue fillers like hyaluronic acid and fat injections experienced some of the largest growth in the minimally-invasive market during 2011. More than 1.3 million hylauronic acid procedures were performed in 2011, up 9%; 286,000 calcium hydroxylapatite procedures, up 36 percent; and 68,000 fat injections, up 19%.

The top five reconstructive procedures were:

• Tumor removal (4.2 million, up 3%)
• Laceration repair (303,000, down 15%)
• Maxillofacial surgery (195,000, up 125%)
• Scar revision (175,000, up 9%)
• Hand surgery (120,000, up 13%)

Breast reconstruction rates continue to rise, with more than 96,000 procedures performed last year, up 3% since 2010. “While insurance coverage for breast reconstruction is mandated by law, continued strides to provide coverage for other reconstructive procedures has contributed, in part, to the sizable gain that we are seeing with these procedures,” says Roth. “Reconstructive surgery is a critical pillar of the specialty, and it is encouraging to see that increasing numbers of patients entrust board-certified plastic surgeons to reconstruct their bodies after disease or trauma.”

The new statistics are based on procedural information reported through the first online national database for plastic surgery procedures, Tracking Operations and Outcome for Plastic Surgeons (TOPS). This data is combined with the annual survey sent to American Board of Medical Specialties certified physicians most likely to perform these procedures.

Source: ASPS

Repeat surgery

Most women who have implants achieve satisfactory results from one operation, and the implants remain indefinitely without difficulty. As many as 20% of women may need repeat surgery (often more than once). Reoperation may be required for a host of reasons, and for a few women, these devices become high-maintenance items. To place this in perspective, do not expect more from an implant than from any natural body tissue or organ. These devices can be thought of as new body parts and, like our own organs, they may last a lifetime or cause frequent difficulty throughout life.

Capsular contracture

Often referred to as a complication, this phenomenon best is considered an adverse effect. It is the result of the normal process of scar formation resulting from the repair of separation of tissue. One would not consider the skin scar a complication of a cut despite the spectrum of final appearances. Shrinkage or shortening of a scar is a poorly understood phenomenon that varies dramatically among individuals and at different locations and directions on the same person. Contracture around an implant is probably an aborted attempt at extrusion of a foreign body. In truth, the mystery is why contracture does not occur in everyone.

Contracture is the most common adverse effect of breast implants. To achieve a soft, natural-feeling result, the surgical pocket is made somewhat larger than the implant. Normal wound healing forms a scar lining on the pocket surface termed the capsule, which, under ideal circumstances, retains its original dimensions. The oversized pocket permits full flexibility of the implant, often resulting in a breast so soft that the implant is not palpable and closely mimics normal breast mobility and softness.

For reasons that are unclear and appear to be related to a particular woman’s individual biology, the scar envelope sometimes shrinks and squeezes the implant, producing varying degrees of firmness. This commonly is graded on a scale devised by Baker, as follows:
•
Grade I – None: The augmented breast feels as soft as an unoperated breast.

•
Grade II – Minimal: The breast is less soft; the implant can be palpated but is not visible.

•
Grade III – Moderate: The breast is firmer; the implant is felt easily, and its presence is visible.

•
Grade IV – Severe: The implant is firm and often tender, painful, cool, and distorted; its presence is obvious.

Contracture can occur soon after surgery or many years later and may be symmetric, asymmetric, or unilateral. Current theory suggests that low-grade contamination by Staphylococcus epidermidis may be the initiating factor of the contracture, but this is not confirmed.

Capsular contracture is not, in itself, a health risk other than its possible interference with mammography or the risk of surgical correction, if required. However, contractures detract from the quality of the results, with the severity of concern depending upon the individual patient. The best results achieve the ideal of a breast so soft that the implant is undetectable. Yet many women prefer a slightly firm bosom while for others even a severe contracture is only a minor nuisance.

The amount of overlying breast tissue as padding influences both the sense of softness and the appearance. If the tissues are tight, usually the breast has a superior fullness similar to the effect of a push-up bra. The most severe degree of contracture may be unaesthetic or deformed, quite uncomfortable, or chronically painful.

The recent innovation of texturing the implant shell initially showed promise of reducing the incidence of contracture. However, recent data from both US manufacturers have been confusing but suggest that little or no difference exists for saline implants. In contrast, the most recent information concerning gel implants demonstrates statistically less contracture in cosmetic patients (smooth 15%; textured 9%; P < 0.01) with the textured variety but does not seem to make any difference in reconstruction (smooth 13%; textured 12%).

An undesirable adverse effect of texturing is an unpleasant rippling of the breast surface, especially if little overlying tissue padding is present, such as in reconstruction of very small breasts. This may be visible and unsightly or just palpable and annoying, depending on the thickness of normal breast tissue and subcutaneous fat available to mask the irregularities. For most women, firmness is a more acceptable compromise than rippling, especially if it is in the cleavage area.

Carcinogenesis

No evidence exists that the silicone used in breast implants is carcinogenic in humans. More than 7 epidemiologic studies confirm this, at least for the 10- to 30-year periods covered by these reports.[6, 7] Three recent large-scale studies and 2 smaller ones have demonstrated that women with implants may have up to 30% less breast cancer than expected statistically when matched with the general population.

Three animal studies show the same protective effect, and one preliminary report suggests that blood from women with implants kills breast cancer cells in tissue culture. Therefore, all evidence suggests that at least for the greater than 30-year time frame that silicone implants have been available, the risk of humans developing cancer from silicone breast implants is negligible, if not nil. Recent studies also demonstrate that 5-year survival rates are not affected by the presence of these devices.[8]

A recent study from the National Institutes of Health (NIH) demonstrated the development of myelomas in susceptible strains of rats injected with gel in their peritoneal cavities. This was not observed with oil or elastomer. Eighteen cases are now in a newly established registry at NIH. They are clustered in Los Angeles, Arkansas, and Florida (no new cases have been added since the first 18 were collected 4 y ago).

Monoclonal gammopathy of undetermined significance (MGUS) is found in the serum as a monoclonal immunoglobulin G or immunoglobulin A in 1.5% of the otherwise healthy population. This is believed to have some predictive value in determining the risk of myeloma, since 16% of those with elevated levels develop the disease within 30 years (0.8%/y). A small sample of women with implants has demonstrated an elevated MGUS fraction. However, a search through 4 registries containing more than 20,000 women with more than 120,000 years of risk located only 1 case of myeloma. This information should be considered and studied further, but the evidence is too sketchy to generate alarm. A statistical truism is that “an association does not imply a cause-and-effect relationship.”

Polyurethane-coated implants

The polyurethane coat that covered some implants in the United States before 1991 is known to slowly hydrolyze over several years into unknown breakdown products. Of concern is one constituent of the polymer, 2, 4, toluene diamine (TDA). In studies performed in the 1960s, large doses of TDA fed to highly cancer-prone rats produced hepatomas. When viewed in the light of more modern understanding, the validity of these early experiments is questionable.

TDA never has been documented to be a human carcinogen, but because of this animal evidence, current law, known as the Delaney clause, requires that it be banned by the FDA for use in foods, cosmetics, and implantable devices. (Congress has recently amended this clause to make it more pertinent to scientific reality.) However, no evidence exists that TDA is formed in vivo from polyurethane. While TDA is a building block of polyurethane, it is not produced by hydrolysis, since the molecule is cleaved at the urea fraction rather than at the TDA site. An FDA advisory panel hearing held in July 1991 concluded that the probable cancer risk from polyurethane-coated implants is considered negligible (< 1 in 1,000,000).

More recent studies have demonstrated that approximately 80% of women with these devices show traces of TDA in their urine. Traces of TDA also were found in the urine of 11% of the control group, suggesting an environmental source of the chemical. None was found in the blood of patients or controls. Again, the risk of cancer from polyurethane implants was calculated to be less than 1 in 1 million. To date, no cases have been reported in the medical literature of cancer in a woman with polyurethane implants. Because the small but real risks associated with removal are greater than the risk of cancer, the FDA has advised that there is no health related reason that requires removal of these particular devices in asymptomatic women.

Cancer detection

Perhaps the most significant concern regarding breast implants is the possibility of delayed detection of breast cancer. The implant itself is radio-opaque and variably compresses the breast tissues depending upon the particular configuration of a particular woman’s breast architecture and the degree of contracture. A real concern involves the presence of an implant compromising mammography and delaying detection until the mass is large enough to be palpable. Several recent studies have shown that this appears to be only a theoretic risk, since the stage of detection of the breast cancer in women with implants appears to be identical or better than that of the overall population.[9, 10]

Mammographic techniques have improved dramatically in the last few years, enabling the mammographer to minimize the amount of breast that is hidden by an implant. Approximately 9% to more than 20% of breast cancers in all women are invisible on radiographs. Despite the increasing use of mammography, most breast cancers still are discovered by self-examination or physician examination. Many clinicians believe that the presence of an implant can increase the ease of palpation. To date, no cases have been documented in the medical literature in which a diagnosis of breast cancer was delayed by the presence of an implant. This suggests that this is a rare occurrence, at worst.

The Society for Breast Imaging, the American Society of Plastic and Reconstructive Surgeons (ASPRS), and the American Cancer Society agree that a woman with breast implants should be on the same schedule of routine mammography as other women, as follows:
•
Baseline – At the earliest when aged 35 years

•
Biannually – When aged 40-50 years

•
Annually – When older than 50 years

However, a woman with breast implants should avoid screening clinics where only 2 routine views of the breast are taken.[9, 11] Instead, she should be referred to mammographic units accredited by the American College of Radiology, which are familiar with the special displacement (Eklund) views required for proper mammographic evaluation of the implanted breast.[12, 13, 14] Ideally, the woman should try to obtain her studies at the same facility each time so that her films can be observed serially, and she should inform the technician that she has implants. Because extra views are required, the cost of the mammogram for these patients is modestly higher.

Preoperative mammograms in women younger than 35 years should be discouraged. Cancers can be observed best when the breast parenchyma is mostly fat. The young breast has dense stroma, thus mammography contributes little or nothing to diagnosis of any breast disease. In addition, evidence exists that the young breast is much more vulnerable to radiation damage.

For excellent patient education resources, visit eMedicine’s Women’s Health Center. Also, see eMedicine’s patient education article Breast Lumps and Pain.

Rheumatologic disorders

The media and the courtroom have made much about autoimmune disease, human adjuvant disease, or silicone-associated disorder (SAD). Almost every disease and symptom complex from scleroderma to chronic fatigue syndrome to multiple sclerosis and amyotrophic lateral sclerosis has been blamed on the breast implant in various anecdotal reports. More than 200 separate conditions have been listed in plaintiff pleadings as having been caused by these devices. The College of Rheumatology, American Medical Association, and FDA agree that the term human adjuvant disease is inaccurate and inappropriate. These disorders, if they exist, should be labeled simply rheumatologic or immune disorders.

Of those rheumatologic disorders most likely to be caused from exogenous sources, scleroderma (sclerodermalike syndrome is the correct term for the variants that arise from exogenous toxins), lupus, and Sjögren disease are the most probable candidates. Scleroderma is a rare disease with an estimated incidence of approximately 10,000 new cases per year in the United States. A search of the medical literature in 1995 documented approximately 130 cases of scleroderma in women who also happened to have breast enlargement. (This number includes a significant group that was injected with unknown substances such as paraffin or adulterated silicone.)

Since these are rare diseases, they require large-scale epidemiologic studies to determine if a relationship is present. Currently, 31 such studies from 4 countries encompassing a cohort of more than 500,000 women failed to find a statistical relationship between any known or newly recognized disease and silicone.[15, 16, 17, 18, 19, 20, 21, 22, 23, 24]

A panel of experts appointed to review all of the literature for the court with jurisdiction over the implant class action suit summarized their findings as follows:

No association was evident between breast implants and any of the individual connective tissue diseases, all definite connective diseases combined, or the other autoimmune/rheumatic conditions. Sjögren’s syndrome was a possible exception to this statement. This entity requires salivary gland biopsy to meet the published diagnostic criteria. Whether biopsy was actually performed for cases in the studies cited is unknown. The remaining criteria based on dryness of the eyes and mouth with possible immunologic alterations are nonspecific and relatively common in any population group. Thus, the accuracy of diagnosis of Sjögren’s syndrome in the studies incorporated in this meta-analysis is questionable.

Additionally, some claim that silicone causes a totally new syndrome (termed by some silicone-associated disorder), often presenting as a unique variant of fibromyalgia, which may be associated with implants. These all have been based on anecdotal reports, and no epidemiologic studies have been performed to support this claim. On October 22, 1995, the American College of Rheumatology issued the following strongly worded statement critical of claims of such new disorders: “The ACR believes that these studies provide compelling evidence that silicone implants expose patients to no demonstrable additional risk for connective tissue or rheumatic disease.”

Thus, of the many other symptom complexes, illnesses, and disorders claimed by patients, some physicians, the plaintiffs’ bar, and the media to be due to implants, none stand up to scientific scrutiny.

The intensified interest in this issue has generated a great deal of laboratory research in many centers. In some instances, an immune response has been observed in animals, while others have demonstrated positive laboratory findings in a number of women with implants. While animal studies are useful to gain an understanding of processes, extrapolation to humans is often inappropriate. None of the published material to date has presented evidence for a convincing cause-and-effect relationship with any human disease entity. Unfortunately the lay public, the media, and some physicians have equated an immune response, as manifested by laboratory tests, with disease. An immune response is not an immune disease.

As early as 1989, a Plastic Surgery Educational Foundation (PSEF)-sponsored consensus panel on this subject concluded the following:
0.”There is insufficient information available at this time to determine whether silicone in the form of a breast implant can be implicated as a cause of scleroderma-like syndrome or any other autoimmune disease. Judging from the paucity of reported cases in the very large population of implanted women, if a causal association were to be established, the statistical risk would likely be very low. The presence of risk and magnitude thereof can be determined only by appropriate epidemiological research.”
0.”At present, there is no reason to discourage women from considering breast augmentation on the basis of the risk of acquiring or exacerbating a connective tissue disorder. Until the question is answered by further research, it is wise to inform patients that a theoretical risk might exist, especially if they already have a connective tissue disorder, idiopathic Raynaud’s phenomenon, or an affected first-degree relative.”

Therefore, if a relationship is present, it must occur in a small number of women who have a genetic predisposition for the disease for which no predictive test is available. The workshop participants repeatedly emphasized that assuming that the presence of an association between two findings implies a cause-and-effect relationship is flawed logic. This truism is understood poorly by most, thus easily is exploited by those who would profit from vilifying the device. In general, while publicly neutral, privately a strong air of skepticism existed among the participants concerning cause and effect.

In 1991, an FDA panel of experts, having heard all of the then-current evidence that suggested a connection between silicone gel breast implants and rheumatologic disorders, concluded that “the evidence was unconvincing.”

At an NIH-sponsored workshop on silicone implants and atypical rheumatic disease, the evidence for a relationship with known typical disease was again acknowledged as not convincing. The participants affirmed that the diagnosis atypical connective tissue disease was ill-defined, especially for those disorders that rely on subjective symptoms only and are devoid of objective findings or diagnostically specific laboratory findings. The currently classified atypical disorders represent a hodgepodge of subjective symptomatology with or without nonspecific abnormal laboratory tests. They are useful for the purpose of assigning a diagnosis for record keeping, insurance, and patients’ needs for labeling but should not be considered as clearly defined entities.

The absence of a clear definition and classification of these vague ailments makes validating their existence impossible. A substantial portion of the rheumatology community is skeptical that such disorders even exist as defined entities. Thus, pinpointing any specific disorder as caused by breast implants is insupportable. Until consensus is reached and these disorders are defined clearly or discredited (estimated to require 10 y if started today with adequate funding), abuses and misuse of these diagnoses will continue.

Interestingly, manufacturers and physicians are criticized by the plaintiffs’ bar, the media, and unhappy patients for not determining whether implants cause these diseases, when the technology to do so does not exist today, let alone 10-20 years ago.

Finally, several reports state that reversal of the symptomatology can occur with removal of the implants. However, the evidence to date is confusing and suggestive of a placebo effect, the natural ups and downs of the disease, or the results of concomitant treatment.

Silica: Silica in its crystalline form is common sand, marble, or quartz. It also occurs in an amorphous form. Very fine, extremely pure, amorphous silica is used as a filler to strengthen solid silicone, such as in the shell of an implant. Each grain of silica is encapsulated tightly in silicone so that even when the elastomer is abraded or torn, no silica is exposed to the body.

Silicate: In one form, its hydroscopic properties are used to keep the contents of containers dry.

Silicone: Substances known as silicones are polymers of silicon and oxygen. Silicone has as many forms as its carbon-based sister, oil. Like salad oils versus motor oils, not all are fit for human consumption. Dimethylsiloxane is the building block for most medical-grade silicone products, including breast implants. It can be made extremely pure and modified into products with a multitude of characteristics (see the image below). The molecular structure of silicone.

Implant characteristics

Keep in mind the difference between elemental silicon and the polymer silicone. Medical-grade silicone is usually a specific, very pure polymer of silicon and oxygen with methyl side groups (dimethylsiloxane). It is one of the least bioreactive materials available for use in medical devices. The shell is made of a rubberlike membrane of fully polymerized silicone with an amorphous (noncrystalline) silica filler added for strength.

Until the moratorium, most implants used were filled with a silicone gel, the physical form of which can be likened to a spongelike matrix or 3-dimensional net filled with various chain-length silicone oils. These form a physical chemical bond resulting in a gel. The shell membrane is slightly permeable to the oils.

Depending upon the brand, age, characteristics, and environmental mechanics of a particular device, small amounts of the oil diffuse or bleed through the shell. For most implants, this is a matter of a few grams. Newer barrier coat devices introduced in the early 1980s bleed at as little as one tenth the rate of the older materials.

This leakage of silicone should be viewed in perspective. Medical-grade silicone is ubiquitous in the environment, and probably everyone in the civilized world has some form of silicone in his or her body. For example, every disposable needle and syringe, as well as intravenous tubing, is lubricated with silicone. (The FDA permits up to 1 mg/cm2 of barrel surface.)

Medications in stoppered vials contain residual silicone from its use in the manufacturing process. Silicone is hydrophobic and lipophilic; thus, various amounts may be injected along with the medication depending upon the lipid characteristics of the drug used. Because insulin binds to silicone, extrapolative calculations suggest that patients with type I diabetes may inject as much as 25-30 g of silicone over a lifetime.

In its solid form, silicone elastomers are used for pacemaker coatings, tubing, prosthetic joints, hydrocephalus shunts, penile implants, and as the envelope for Norplant and other implanted drug delivery systems. Some testicular and chin implants are similar to breast implants, since both usually are made of a silicone gel in a silicone envelope.

More than 1000 medical products contain silicone as either a component or as a residuum from use in the manufacturing process. Silicone is a nonspecific term for a class of compounds, some of which are highly reactive or toxic. The generic term silicone is similar to the generic term oil, which can include both salad oil and motor oil. Within the subclass of medical-grade material, the formulations vary to some degree with intended use. The body may react differently to some of these formulations.

The designation methicone (as in simethicone or dimethicone) as an ingredient in any medication is simply silicone formulated to comply with FDA regulations for human consumption in items such as medication, foods, and cosmetics. Calcium carbonate, magnesia, simethicone antacid (Di-Gel), and oral simethicone (Mylicon) are examples of medications containing silicone that are marketed over the counter, even in pediatric formulations, with FDA approval. Silicones are used in lipstick, hairspray, food processing, skin creams, and cosmetics and are known to be absorbed through both the bowel and the lungs.

Biologically, medical-grade silicones invoke a straightforward, nonspecific foreign body response, resulting in typical macrophage invasion, giant cell formation, and eventual scarring. Several animal studies suggest that relatively huge volumes of gel injected into the peritoneal cavity of rodents may stimulate an immune response. This is not observed with the oil or solid elastomers. It can be demonstrated only by emulsifying the gel, a condition not seen in the implant. Intact gel does not lend itself to these test procedures.

Despite the many reports in the media, exhaustive evaluations by multiple prestigious scientific bodies such as the Institute of Medicine, the British Ministry of Health, the Spanish Government, a committee of the European Union (EQUAM), Harvard University, the Mayo Clinic, and multiple panels of experts established by various courts have confirmed that no evidence exists of any known or new systemic illness definitively attributed to silicones.

Thus, in contrast to the common cliche, these women seek augmentation despite, rather than because of, social pressures. The depth of this personal need and the importance of this procedure to their sense of wholeness and self-esteem are difficult for even their loved ones and their personal physicians to appreciate. Only the woman and perhaps the plastic surgeon who hears these stories over and over again can understand the power of this need and the significant enhancement of quality of life that these devices provide.

Several surveys consistently have demonstrated that 90-95% of women who have undergone cosmetic augmentations are pleased that they did so, even if the results were less than ideal or were accompanied by complications. At the height of the negative media information in 1991, a survey of 300 plastic surgeons revealed that approximately 3% of these women made inquiries about removal due to concern over safety. Less than one half followed through, which is a measure of the great value of this operation.

This estimate is similar to the percentage of women who took advantage of the implant manufacturers’ offer of financial support for implant removal or replacement. Plastic surgeons suspected that the number of requests for removal of gel devices, usually with saline replacement, increased commensurately with the publicity over the multibillion-dollar class action settlement.

The desire of most women to replace their implants with saline (76% according to a recent study by Spear and Bowen) reflects their satisfaction with the enlargement. More recently, as reassuring research on safety has become available, interest in removal appears to have fallen significantly. Current estimates suggest that 85% of removed implants are replaced. A 1998 attempt to study explantation prospectively failed for lack of candidates. Some women, having experienced both gel and saline, are requesting a return to the gel as they felt that it provided a superior result.

More implants are sold on either coast, suggesting the existence of regional differences in body image. This becomes moot when one realizes that women in the Midwest buy larger bras on average than those that are sold on the coasts.

The anxiety generated by the 1990s media scare and dramatic litigation awards has diminished the significant psychological benefit that accrues from implants. This concern seems to be diminishing; as noted below, the number of cosmetic augmentations now appears to exceed premoratorium estimates following the significant dip of the early and mid-1990s. Therefore, all caring physicians must share the truth with their implant patients and reassure those who have chosen to accept whatever risk may be present.

Table 1. Annual Implant Sales by Pairs (Open Table in a new window)

1990

120,000

1991

110,000

1992

60,000

1993

76,000

1994

84,000

1995

99,000

1996

118,000

1997

ASPS

122,000

ASAPS

101,000

Manufacturers

230,000

1998

ASPS

132,000

ASAPS

126,000

Manufacturers

300,000

1990-1996 figures represent manufacturer’s estimates for all implant sales, including augmentation, reconstruction, and replacement. American Society of Plastic Surgeons (ASPS) and American Society for Aesthetic Plastic Surgery (ASAPS) data represent separately collected and analyzed membership statistics on cosmetic augmentation using different methodologies. These do not include patients of nonmembers, which is substantial. All numbers are approximations.

Contraindications

Aside from the usual medical conditions that would increase the risk of anesthesia, surgery and/or infection, the most significant red flag, as in all cosmetic surgery, is an unrealistic expectation. Women who are emotionally unstable or are requesting the surgery to please another person should be discouraged from undergoing the procedure. However, this should not be considered a blanket contraindication.

Each patient must be individually evaluated and a decision made as to whether the procedure will enhance the quality of her life, her sense of self, and her sense of well-being. Plastic surgeons must develop the skills to evaluate these intangibles and take the time for a proper evaluation. Because it is so subjective, do not expect 100% accuracy in predicting the outcome; guessing correctly 95% of the time is the best that can be expected.

The number of women in the United States who have breast implants is unknown, but current estimates derived from national surveys range up to more than 6 million. This represents more than 5% of the adult female population. The American Society of Plastic Surgeons (ASPS) collects information annually on plastic surgery procedures performed by its members. In 2008, approximately 307,000 women received breast implants for cosmetic breast augmentation and 111,000 for reconstruction of congenital or postmastectomy deformities.[1] These data do not include those procedures (mostly cosmetic) performed by non plastic surgeons such as otolaryngologists, general surgeons, gynecologists, and others.

Following adverse publicity in the early 1990s, interest in the procedure fell significantly, especially for gel-filled devices, but it seems to have recovered incrementally. According to the ASPS, in 2008, 53% of total breast implants were filled with saline; 47% were filled with silicone.[1]

Prior to 1963, various plastic foam materials were used; for breast augmentation, however, it became apparent that the air cells would collapse and, combined with tissue ingrowth, shrink and harden the device. These materials were wrapped in plastic film to minimize this effect to no avail. Amazingly, some of these implants were so well tolerated that they have stayed in place to this day.

The modern silicone breast implant has been available since 1963 and has gone through an evolution of change and improvement. Several types of devices, with many variations, shapes and styles within each class, are now available or under testing for US Food and Drug Administration (FDA) approval. Basic to all implants is a silicone rubber (elastomer) shell, which can be single or double, smooth or textured, barrier-coated, or covered with polyurethane foam. The foam-covered devices have not been available in the United States since 1990 but are still marketed in Europe.

The contents are either factory-filled with silicone gel of various consistencies or inflated at surgery with normal saline. One brand that was manufactured overseas was prefilled with saline at the factory. It was briefly marketed in the United States but was later withdrawn when the FDA denied approval.

The double-lumen devices consist of concentric balloons that contain silicone in one chamber and saline in the other. The only one still in use is the Becker, which has an outer layer of gel and an inner balloon that is valved to permit postoperative gradual inflation with saline. This is termed a “permanent tissue expander,” since it permits gradual and temporary overinflation to create the pocket and then can be left in as a permanent implant after the size is adjusted appropriately. At this writing, the Becker devices are not generally available in the United States until current FDA mandated studies are evaluated.[2] For more information on expandable implants, see eMedicine article Uses of the Postoperatively Adjustable Implant in Aesthetic Breast Surgery.

In 1990, the FDA placed a moratorium on gel-filled implant use for cosmetic augmentation. They remained available for reconstruction and replacement, but mandated extensive record keeping, follow-up, and IRB approval were required for use. In 2006, after extensive study and analysis, the FDA deemed the device safe for all augmentation and reconstructive purposes, but they continue to require tracking of patients.

Saline Implants

Saline filled implants are available as empty silicone balloonlike devices to be filled with normal saline at the time of surgery. This permits subtle size adjustments to compensate for asymmetry between the breasts. They are less popular than silicone implants, as they often may have a less natural feel. If the patient has very little breast tissue or only a skin covering after mastectomy, unsightly wrinkles and folds of the device may be visible on the breast. This is more common when the surface is textured.

Silicone Gel Implants

Three generations of basic design of this device have been created, with many variations within each type.

First generation

The first models to be marketed had envelopes of thick, smooth-walled silicone elastomer made in 2 sections, filled with a viscous silicone gel material (dimethylsiloxane) and glued together. They were available in only three sizes: small, medium, and large. In the first few years, surgeons believed that the device required attachment to the tissues to prevent migration. Scar ingrowth for fixation was accomplished by patches of material (eg, Dacron mesh or perforated silicone) attached to the back of the device or by an outer covering of polyurethane foam. The Dacron and silicone patches were subsequently found to be unnecessary; they actually detracted from the quality of the result. Some patches or tabs created a stress point that led to tears of the envelope. Fixation patches were eliminated in the early 1970s.

Second generation

Manufacturers varied the gel consistency and shell thickness in an attempt to improve performance. Beginning in the mid-1970s, the shells were made thinner and the gel less viscous (ie, more “responsive”), primarily in an ill-conceived attempt to control hardening from scar shrinkage (capsular contracture.) This trend reversed in the early 1980s when it was recognized as not effective in reducing contracture and as resulting in a more fragile device. Most were broken 10 years later.

Third generation

New formulations of the shell and gel contents became available that were stronger and had a second barrier coat of diphenyl silicone. This coating almost totally eliminated so-called “gel bleed” or diffusion of small amounts of the silicone oil through the implant shell. The gel content also was made more viscous and cohesive.

In 1989, textured-surface shells that many surgeons hoped would minimize the incidence of unwanted firmness from capsular contracture became available. Recent studies are somewhat confusing regarding whether this was effective. The textured implants had the disadvantage of a higher rupture rate than the more traditional smooth shells and often produced visible wrinkles in the breast in women with very little overlying tissue to mask the ripples. Because of these shortcomings and lack of solid evidence that these devices were softer, they have become much less popular in recent years.

Polyurethane-covered implants

In the late 1960s, a variation of the device was developed containing a polyurethane sponge coating over an otherwise standard gel-filled implant. Although the coating originally was planned as a fixation layer, many surgeons came to believe that the foam cover resulted in a decreased incidence (or at least a delayed onset) of capsular contracture. These implants also evolved in shape and design, culminating in the early 1980s with the Meme and Optimam styles. In April 1991, the manufacturer voluntarily withdrew the foam-covered implants from the market.[3]

One style, the MemeME, had a unique construction. It had no true shell, but a skin of sorts was formed in situ by spraying the surface with silicone containing extra catalyst prior to curing. This increased the crosslinking of the surface to create a shell-like membrane. The polyurethane foam was then shaped and sealed over the surface. Implants of this particular type were known to occasionally extrude some of their gel contents through the foam when squeezed. This is a possible explanation for reports of blood being found within the substance of the gel in apparently intact implants. The MemeME model was marketed from 1983-1988.

Other filler materials

While silicone remains the only available shell material, new filler substances were in use in Europe and South America and, at one time, were under development or in experimental trial in the United States. Various hydrogels and a pure form of triglycerides were the 2 main formulations. The major advantage of the triglyceride formulation (Trilucent) was that it had a Z number (measure of radiolucency) similar to that of fat, thus resulting in little or no compromise of mammography. Another fill substance, polyvinyl pyrrolidone in saline, was briefly available, under the trade name Misty Gold. None of these products is currently available in the United States. At this time, only silicone gel or saline-filled models are available for use in the United States.

Recent developments

In late 2006, a new formulation of silicone gel filler called MemoryGel (Mentor Corp, Santa Barbara, Calif) gained FDA approval.[4] This gel implant is thicker and more cohesive so as to minimize gel spread in the case of rupture and to resist scar shrinkage that would deform its contour. When cut, the gel retains its shape and doesn’t run. This device has a doughy feel to it.

Currently available devices in the United States are saline- or silicone-filled implants with either textured or smooth surfaces. They come in round or tear drop shapes with a choice of 3 different projections. Only 2 companies, Mentor Corporation and Allergen (a successor to McGhan and Inamed), have FDA approval to market these devices in the United States.

The implants produced currently are much improved devices compared to earlier units. The shell is still made of an outer layer of a mix of dimethyl siloxane and amorphous silica with an inner barrier coat of diphenyl siloxane to minimize silicone gel bleed. The shells, on testing for breakage, exceed the American Society for Testing and Materials (ASTM) requirements by more than 300%. The gel is more cohesive, varying from a standard 60% crosslinking to 80% for the more cohesive type nicknamed “gummy bear” (because of is consistency similar to the candy).

As evidenced by sales figures prior to the moratorium, and now following their release for cosmetic purposes, approximately 80-85% of surgeons and patients prefer the quality of results obtained by gel implants, making them the implants of choice. In 1997, sales figures for Europe, where usage was unrestricted, show a distribution of 70% for gel, 15% for saline, and 15% for alternate fills such as triglycerides (then still available) and hydrogels for cosmetic use.

Safety

Silicone is probably the most studied implantable material available today. After over 35 well-conducted studies from many countries, it seems certain that this material does not cause disease. The results of more than 7 long-term follow-up studies show that women with implants have a reduced incidence of breast cancer than is otherwise expected in the general population. No hard evidence reveals that a broken implant is harmful. Almost all of the problems that can occur with breast implants, such as infection, hardening, extrusion, and malposition are related to the surgical procedure or the patient’s own biology, not the device.

At the 2011 American Society of Plastic Surgeons Annual Meeting, Michael Kane, MD, a plastic surgeon in private practice in New York City, discussed the most recent phase 2 studies on RT001 involving 90 and 180 patients.[2] He summarized the results of 11 clinical trials on RT001, involving over 550 patients, by concluding that the compound has had a 115-day duration of effect with no serious treatment-related adverse events. Speaking more specifically about the recent 90-patient, 3-site, randomly controlled study, he reported a ≥ 2-point improvement in lateral canthal lines in 44% of the treatment group vs 0% in the control group (P < .0001) and a ≥ 1-point improvement in 89% of treated patients vs 28% of controls (P < .0001). For the larger 5-site study, RT001 was compared with each of its 3 components – the BoNTA alone, the transport protein alone, and the gel placebo alone. RT001 results were statistically significant compared with each of the individual components and all 3 components combined (P < .0001). RT001 also showed significant lateral canthal line improvement of at least 2 points as assessed by both the provider and the patient (P < .0001).Additionally, the results are quite impressive, based on photos I have seen, and it appears the agent does not diffuse or spread beyond the area of treatment. While the initial data seem promising, there remain questions of application in other areas and details that could only be gained by phase 3 and 4 studies. I am not an investigator for this agent but I look forward to seeing this added information. FDA approval is extremely unpredictable no matter the strength of the data; your guess as to when approval might occur is as good as mine.

Such implants had been banned because of concerns about possible links to systemic diseases, including cancer and lupus, which have never been substantiated with the wealth of data accumulated on the devices over the years. However, when the FDA lifted its ban on silicone implants it did so with conditions stating that breast implants did sometimes cause adverse effects, and were not lifetime devices. Because of this, they required manufacturers to do studies on the implants’ safety and performance after their approval.

As we already knew, study findings announced earlier this year did not show an increased risk of breast cancer or connective tissue disease, although FDA officials noted that longer studies were needed. Although the FDA has also recently cautioned that breast implants might be linked to a higher risk of a rare form of lymphoma called anaplastic large cell lymphoma, officials called those chances slim. The safety findings were based on preliminary data from six ongoing post-approval studies conducted by Allergan and Mentor, the only two companies that make silicone implants for sale to physicians in the United States.

Common issues surrounding silicone gel-filled implants include fibrous capsular contracture, or hardening of the capsule around the implant, the likely need for future surgeries and possibly even implant removal. Other possible complications include implant rupture, wrinkling, breast asymmetry, prominent scarring, pain and infection.

But Allergan and Mentor acknowledged problems with low patient follow-up in their post-approval studies. Allergan’s response rate for the post approval studies was 60% and Mentor’s was 21% (described as being so low due to the fact that the study was initially termed “mandatory” and then made voluntary, leading to many patients to defect from the study).

Presently, the FDA recommends that women follow-up regularly with their plastic surgeon, MRIs to detect potential ruptures (probably overkill as MRI’s are expensive and insurance won’t cover them for random checks without cause of possible rupture). Patients should aslo pay attention to any changes and notify their surgeon if they notice any unusual symptoms such as pain, asymmetry or swelling, and educate themselves on the signs and symptoms of complications.

The FDA said it wants to find ways to improve post-approval safety studies and new approaches to mandate studies for the surveillance of silicone implants. Silicone implants are the most studied medial device in the history of modern medicine, so it wil be interesting to see how the FDA will go about this to yield any new or useful information on the very popular medical device that around 400,000 women per year get in the United States.