In the darkness of an early Florida morning one April, a cab driver encountered a frightening sight. Collapsed on the sidewalk near a cosmetic surgery clinic was the body of a woman wearing a bloody garment and tangled in a web of intravenous tubing and monitor wires. The driver called police, and the woman was taken to a hospital, where she spent five days in intensive care. The woman later recounted that she had awakened in the fi fth floor clinic gasping for breath but unable to find anyone to come to her aid. Too weak to walk, she dragged herself to the elevator and eventually into the street where she was found at 3:30 a.m. Despite advances in medicine that have dramatically improved patient safety, too many purveyors of cosmetic medicine have practiced for too long without regard for established standards of care. This problem exists in part because providers do not want to add to their bureaucratic burdens and in part because lawmakers and the public tend to view cosmetic interventions as less risky than “real surgery.” Well-respected surgeons tout cosmetic surgery as a legitimate path to happiness but want neither to acknowledge less credentialed yet legally sanctified providers in the field nor police those within their own ranks. State lawmakers, seeing cosmetic procedures as a winning lottery ticket, rush to tax cosmetic surgery as a vanity service as opposed to medical care (one legislator reportedly admitted that she thought up the idea one night while watching Extreme Makeover) but fail to pass or enforce laws that protect cosmetic patients from unqualified practitioners working in unregulated offices and spas. People from both medical and nonmedical backgrounds refer to medical grade injectables as “lifestyle drugs,” the same term usually reserved for club drugs such as Ecstasy and marijuana. Every person contemplating a cosmetic intervention wants a good result, but few are willing to acknowledge the possibility that deformity or even death is a possible outcome.

Cosmetic medicine is one of the largest yet arguably the most poorly defined and unregulated segment of health care in America. The potential for easy profits has attracted legitimate practitioners, hustlers, frauds, and criminals. Too many patients have undergone cosmetic procedures and had catastrophic outcomes. It is highly likely that many undesirable results go unreported because an unknown but perhaps very large number of procedures are performed in illicit settings on immigrants and others who tend to avoid the legal system even after they have been harmed.

THE FLORIDA STORY

In Florida, mortalities after cosmetic surgery caught the attention of reporters from the Sun- Sentinel, who launched a lengthy investigation, the results of which they reported in an ongoing series of articles (later nominated for a Pulitzer Prize) beginning in 1998.1 The content of those articles, the state government’s response, and the backlash from certain segments of the medical profession provide an eye-opening look at the business of cosmetic surgery in a state with reportedly the highest use per capita of cosmetic medical services in the country.

The reporters found that, for starters, they could not even determine the prevalence of mortalities after cosmetic surgery because most procedures were (and still are) performed in private offi ces, and in Florida at that time deaths after office procedures did not have to be reported. The reporters examined thousands of fi les and compared lawsuits, insurance claims, police reports, and other public documents in order to cull those deaths related to cosmetic procedures. Most of the cosmetic surgery deaths that were identified, even though temporally related to a medical procedure, had not been formally investigated by the medical examiner, and the cause of death was sometimes listed as due to natural causes. Ultimately, it was determined that dozens of deaths had occurred as a result of cosmetic procedures performed in Florida in just over a decade. From this and other investigations it is apparent that many individuals in our country—not just in Florida—have undergone cosmetic medical procedures under circumstances in which one or more of the following existed:

• The patient was not properly evaluated before surgery and/or monitored and cared for during and after surgery.

• The doctor was not licensed to practice medicine or was not trained or experienced in the procedure that was performed.

• The procedure was performed in a facility that was not licensed, not accredited, not properly equipped or staffed, and sometimes not even clean.

• The patient was taken in by “deals” on counterfeit and downright dangerous drugs, injectables, and devices, or by slick ads, smooth talk, and fancy surroundings. The Florida State Medical Board, distressed by the bad publicity about cosmetic surgery mortalities in the state, resolved to create new regulations for the performance of cosmetic procedures that would be the strictest in the country. Months of contentious hearings and well-funded opposition by certain cosmetic medical provider groups composed mainly of dermatologists, oral surgeons, and otolaryngologists ultimately left the grand plans of the medical board in tatters, although a few regulations did pass. Still, despite the huge amount of negative press and medical board and legislative actions, there were more reports of bad outcomes by unlicensed doctors. This fact led the state legislature to increase the criminal penalties for the illegal practice of medicine, which is still only a misdemeanor in many other parts of the country.

In order to paint a balanced picture of the challenges facing the medical community and lawmakers, several points should be mentioned. First, many cosmetic surgeons, both qualified and unqualified, perform a majority of their procedures in offi ce-based surgical suites, which can be made safe enough for properly selected patients to undergo most cosmetic procedures without undue risk. Second, adverse or even fatal complications can develop after medical and surgical treatments even under the best of conditions by the most qualified providers. Third, there remains considerable controversy as to how length of surgery and anesthesia and the performance of multiple procedures during the same anesthesia affect patient risk. Still, in retrospect, many bad outcomes have resulted from circumstances that did not meet even basic quality of care standards, and an informed prospective patient must place himself or herself in the position to identify these circumstances in advance. Throughout the Florida ordeal, the medical board never effectively addressed the issue of provider qualifications, and this important aspect of patient safety has also, in most states, been left to each patient to assess.

RESPONSIBILITIES PATIENTS MUST ACCEPT

Despite the modern-day enhanced role of patients in the medical decision-making pro cess, patients are not the experts. Patients agree to medical care, cosmetic or otherwise, with the expectation that the provider will in fact care for them. This expectation does not absolve patients of all responsibility in the medical relationship, however. As will be discussed, patients do have certain obligations when it comes to seeking medical care, never more so than when that care is entirely discretionary. Beyond obligation, patients should consider it in their own interests to evaluate safety issues before contemplating undergoing any form of medical treatment. Patient safety has only recently received the same level of public and professional attention as have safety issues in other high-risk industries, despite decades of dramatic press about medical advances. Prospective patients should realize, however, that solutions to certain safety problems may be some time in coming, and patients who do not make an effort to educate themselves about safety issues pass up an opportunity to infl uence their own outcomes.

What follows is a summary of critical safety issues. More details about choosing a doctor, procedures, risks, complications, and outcomes can be found in the next three chapters.

THE FIVE ELEMENTS OF THE SAFETY EQUATION

Full Disclosure

Patients need to be forthcoming in their conversations with their doctors. They must be completely honest with their physicians about their medical history, current and previous medical and mental problems, medication and supplement use, drug and alcohol use, motivations, fears, and expectations. They should educate themselves about their options and the associated risks. Once they commit to undergoing a procedure, they should be willing to follow the physician’s instructions to the letter.

Research the Provider

It is not at all difficult for an unqualified physician to set up shop to offer everything from skin-care advice to cosmetic surgery, and a clever but unethical physician or even a bogus doctor may practice with impunity for years without professional or legal action. In fact, physicians need to do very little to keep out of trouble with the state. The state licensing board investigates individual physicians only if a complaint is fi led, and in some states the reporting and disciplinary process is backlogged, ineffi cient, and sometimes ineffectual. In addition, patients who develop complications or poor results after cosmetic procedures, even if they feel they are victims of negligence, are often too embarrassed or intimidated to speak out unless their situation is dire or worse.

It is common to find clinics, medical spas, day spas, and even beauty salons where nonphysicians perform medical procedures without physician supervision. Whether or not this behavior is legal in a partic ular state, it is the patient/client/customer who is most at risk. Potential patients should think hard about these questions before agreeing to a treatment:

• Who establishes the protocols for treatment? A well-trained specialist or a retired radiologist who has little or no formal training in cosmetic procedures or management of skin and soft tissue problems?

• If you have never met a physician and there isn’t one in the building, why would you assume that an aesthetician or other employee is qualified to make decisions about your skin, perform medical procedures, answer your questions, and manage problems or serious complications? Do you really want someone with no relevant medical training deciding whether you should have a chemical peel, laser or light treatments, or injection of medical-grade substances into your body? Nonphysicians can legally provide many cosmetic medical services. State and federal regulations define what is medical; what are drugs; what a nurse, medical assistant, cosmetologist, or aesthetician may or may not do; whether that person needs a license to do it; how much supervision is required; and so on. States have considerable autonomy in the regulation of nonphysician practitioners, and regulations vary as to who may operate certain kinds of equipment. Some states are more aggressive than others in this regard, and government control is always under attack by those who wish to sell their services. For example, in the state of Ohio a bill was recently introduced that would allow unlicensed and unregulated “alternative and complementary practitioners” to operate without oversight in the state. In other words, these practitioners would not be required to meet any standards of education or training. This bill was strongly opposed by the state medical board and numerous other professional organizations mainly on the basis of concerns for public safety. Bills of this type have appeared in state legislatures across the country.

In addition to traditionally trained surgeons and dermatologists and legally practicing nonphysicians, there are large numbers of minimally or untrained doctors offering cosmetic medical services. Often cosmetic services are offered in conjunction with other “antiaging” treatments such as hormone injections and chelation. Although exact numbers are elusive, as early as 1999 at least 1,700 doctors in Florida (nearly 6 percent of all physicians in the state) promoted themselves as vanity or antiaging procedure experts, with 300 of those doctors having received their Florida medical licenses within the previous five years.2 By every indication the number of physicians offering cosmetic medical and antiaging services is growing rapidly in most states. In addition an unknown but probably significant number of unlicensed providers make the real trade in this segment of “medicine” even busier than can be accurately measured. In Florida, reporters discovered an underground of unlicensed cosmetic “surgeons”—more than a dozen in all—operating out of medical offices, beauty salons and hotel rooms, and several of those pseudophysicians continued to do business even after their arrests on charges of practicing medicine without a license. Despite the establishment of a state task force to ferret out unlicensed doctors, the number of illegal practitioners reportedly also continues to grow. In many cases, these “doctors” fly in from foreign countries and stay just long enough to perform the procedures set up through the illegal network.

Reliable statistics as to who is doing what are hard to come by because states often do not require physicians to report the types of procedures they perform. In 1999 Florida state records showed only 400 doctors specialized in plastic or cosmetic surgery, yet newspaper ads, telephone directories from across the state, and the Internet suggested even then that more than 900 doctors were performing cosmetic procedures. Ads featured dentists, among others, offering hair transplants and liposuction, and ophthalmologists and anesthesiologists doing breast augmentations. In Florida, at least 6 percent of vanity doctors have been the subject of state sanctions, well above the average for doctors as a group.

In Florida and some other states, physicians are not required to carry malpractice insurance or to maintain hospital privileges, and physicians who fit into these categories make up a disproportionate share of the providers of cosmetic medical and antiaging services.

Research the Facility

Offices and Surgery Centers

Governments tend to place relatively few restrictions on the practice of medicine by physicians compared with the voluminous rules and regulations that determine how hospitals must operate. As freestanding ambulatory (outpatient) facilities have proliferated, similar rules have been applied to them. These rules affect operations of health-care facilities primarily by making their eligibility for payment by government and private insurance plans contingent on their compliance. Doctors’ offices are not subject to the same degree of scrutiny, and privately owned for-profit operating suites that do not rely on third-party reimbursement have operated for decades with impunity, with little oversight, and few reporting obligations. This is why cosmetic medical care has flourished largely without restriction by or concern for government regulations.

This lack of oversight has produced some deadly results. As I think back over the span of my training and career, I have been witness to remarkable improvements in the capabilities of anesthesiologists to administer safe, effective anesthesia with relatively few side effects; what a change from the crude techniques I observed in some of the hospitals where I trained. Yet all of this can be lost when patients seek care out of the view of mainstream institutions and other physicians. A 2003 report published in the Archives of Surgery reported a tenfold increase in the risk of adverse events or death in Florida when surgeries (not limited to cosmetic procedures) performed in an office setting were compared with those performed in an ambulatory surgery center. The majority of the office facilities in question were not accredited. The author of the article pointed out that obtaining adverse incident and death information for both offi ces and ambulatory surgery centers is exceedingly diffi cult because “in most states this information simply does not exist.” In March 2004, the editor of the journal commented on the number of negative responses, including accusations of conspiracy, the journal had received after the report was published, and noted that the majority of negative comments had come from within the ranks of facial and cosmetic surgery (mainly otolaryngologists) and dermatology. There are estimated to be 40,000 office- based surgery facilities in the United States, only a small fraction of which are accredited. Only a dozen or so states have regulations in place for such facilities, and even fewer mandate accreditation, a fact that the executive director of the AAAASF (American Association for Accreditation of Ambulatory Surgery Facilities) has called “frightening.” Since at least 60 percent of reported cosmetic procedures, and probably a far higher percentage of unreported procedures, are performed in offices, it is likely that large numbers of patients are exposed daily to potentially substandard surgical conditions. However, no one has a handle on the numbers.

Cosmetic medical clinics frequently are owned and operated by entrepreneurs with no background in any medical field. As part of the series on cosmetic medical care in Florida, Sun- Sentinel reporters described the previous business and sometimes criminal activities of the owners of several very popular clinics in that state. In many clinics in Florida and elsewhere nonmedical owners often evaluate and hire the physicians, who may be salaried or paid cash as independent contractors. Sometimes the physicians have little appropriate training, have worrisome malpractice histories, or even themselves have criminal records.

The good news is that accredited facilities are likely to have the same overall safety record as a hospital. A recent study has documented this fact in relation to facilities accredited by the AAAASF, which is one of three national accrediting organizations.6 Key elements for accreditation include mandatory surgical outcome reporting and a requirement that physicians working at the facility have the credentials to perform the same procedures in a hospital. As Michael McGuire, M.D., then president of AAAASF, stated recently, “That’s the gold standard in patient safety.”

One of the biggest obstacles to improving patient safety obviously has been the difficulty collecting useful data or even establishing what constitutes a medical error. Until recently, there was no centralized national data collection mechanism. There has also been reluctance by health-care organizations and physicians to report errors for fear of retribution. As a result no one knows the actual number of errors that occur in health care or how best to prevent them. In an attempt to rectify these problems and improve the safety of office-based facilities, both professional organizations and the federal government have acted. The ASPS has developed a Web-based data collection system, the first of its kind, for the reporting of surgical outcomes by office-based surgery facilities. The three major accreditation organizations have recently developed a model to define and report medical errors that occur during office-based surgery. A new federal law written with input from patient organizations, health-care groups, and the AMA was signed in mid-2005. The law is called the Patient Safety and Quality Improvement Act and creates a confi dential reporting structure in which errors can be voluntarily reported and subsequently analyzed by patient safety organizations so that safety and quality improvement strategies can be developed. Although this law may be helpful, so long as reporting is voluntary it may be difficult to develop strategies that address the most vital safety issues, especially as they pertain to private offices.

Spas

The number of spas in the United States, now estimated to be more than 12,000, is increasing exponentially in tandem with the boom in minimally invasive procedures. There are an estimated 1,500 medical spas, triple the number that existed in 2004, with revenues expected to top $1 billion in 2006.7 Nonetheless, the term “medical spa” does not really mean anything, despite efforts on the part of spa industry organizations to define the term as requiring the on-site, constant supervision of a licensed medical professional. As of this writing, there is no medical spa accreditation pro cess. Some spas offer only beauty treatments, some focus on cosmetic medical procedures, and many combine the two. Individual state regulations affect how and where spas are set up but do not uniformly regulate, for example, what type of microdermabrasion equipment, light-based therapy and laser treatments, and chemical peel strength may be offered in the absence of physician oversight.

Spa employees may receive training in a beauty or medical fi eld (or neither). There is a marked difference in perspective between retail and medical training. Employees who come from the beauty industry may learn about skin care, but they are not taught health care or the diagnosis and treatment of human illness or injury. They learn to view clients as customers rather than as patients. Even massage therapists are exposed to a completely different educational philosophy than are most physicians and other medical personnel. Perhaps in part because of this clash of cultures, industry reports indicate a high turnover of nonmedical personnel in medical spas.

A physician who is a full or part owner of a spa reaps retail profi ts and benefits from directed referrals. Not all physicians associated with spas are board-certified surgeons or dermatologists, and some have little skin-care or cosmetic medical knowledge and experience. In some states, investor-owned spa franchises comprose a signifi cant segment of the market, leading to the inevitable emphasis on profi ts over quality of care.

Even if a spa is set up with medical-grade equipment and with a physician responsible for what goes on at all times, bad outcomes from treatments performed in spas and similar facilities appear to be rising in frequency. A recent survey of dermatologic surgeons showed that nearly half reported seeing higher numbers of patients in recent years with complications related to medical treatments performed by nonphysicians in spas and elsewhere. Laser hair removal was one of the most often cited treatment categories. Botox injections and leg vein treatments are also commonly performed without good supervision. The existence of rules requiring physician oversight was certainly no consolation to the family of the college student who eventually died from an overdose of the topical anesthetic medication prescribed for her by a medical spa in the name of a physician who had no direct contact with her.

As a general rule, under no circumstances should anyone undergo a medical treatment by laser, light source, or injection, or with prescription-strength chemicals or drugs without having fi rst been evaluated by a qualified physician who subsequently oversees and monitors the treatment. No matter what state laws allow, a patient’s risks increase by having treatments of this nature with no qualifi ed physician on- site.

One can hope that the spa industry will find it to be in its own interest to establish standards for credentialing, training, providing professional medical oversight, and ensuring client safety. That has not occurred yet, and until it does, potential customers should be extremely cautious about undergoing medical treatments in a spa. It will be interesting to see if industry organizations, like the National Coali tion of Estheticians, Manufacturers/Distributors and Associations, can turn their stated goal to standardize education and training for aestheticians into reality.

Financial Risks

Investor-owned cosmetic medical clinics may be sold and resold, which in some cases has effectively prevented owners from assuming liability for past adverse events. In addition, if the physicians employed by the clinic are independent contractors and do not carry malpractice insurance, a patient suffering an injury or worse as the result of a cosmetic procedure may have little financial recourse.