The Tumescent Technique By Jeffrey A. Klein MD
Problems in Reporting Liposuction Deaths
First, do no harm.
Second, learn from mistakes.
Third, teach what you have learned.
Deaths as the result of cosmetic surgery, and liposuction in particular, are probably underreported. Without accurate epidemiologic data, the common causes of liposuction deaths cannot be identified. Without accurate information about the causes of such deaths, it is difficult for surgeons to learn from the mistakes of others. Ultimately, patients will suffer needlessly as a result of surgeons’ collective ignorance about preventable liposuction deaths. The cause may be an iatrogenic complication, or an unfavorable response to a medical or surgical treatment that is induced by the therapeutic effort itself.1
What are the risks of general anesthesia in ambulatory surgery? What are the most risky aspects of cosmetic surgery? Which surgical specialty has had the most deaths among its liposuction patients? My answers here are merely based on anecdotal cases and enlightened speculation. No unbiased statistical studies exist on which to base reasonable answers, and no comprehensive, systematic data have been collected on mortality risks of outpatient surgery. In other words, surgeons simply do not have accurate answers. More surprisingly, the perpetuation of this ignorance seems to be institutionalized throughout U.S. society.
Lack of Epidemiologic Data
Suppose an unrecognized drug interaction causes the deaths of five ambulatory surgery patients each month throughout the United States. Because these cases are isolated and not reported to any centralized registry, the pattern of these deaths might never be recognized. Therefore, every year, 60 preventable deaths might occur.
Surgeons and Quality Control
Surgeons participate in quality control audit programs through hospital-based morbidity and mortality conferences. No mechanism exists, however, to provide a centralized collection and analysis of important sentinel events. A sentinel event is an unusual occurrence that, if recognized and appropriately investigated, can reveal important flaws in accepted clinical practice and standards of care. The surgical specialties have been recalcitrant in accepting responsibility for specialty-wide quality control programs that focus on problems at the surgery-anesthesiology interface.2
Surgeons and anesthetists must know the potential pitfalls, dangers, and potential iatrogenic complications of surgery. Learning about serious complications from the other physicians’ experiences is preferable to self-instruction. Ethical surgeons, however, have no system to report their own adverse outcomes without fear of public embarrassment or professional retribution. Concealing unanticipated disasters and inexplicable complications exposes future patients to needless dangers, and physicians must relearn the same lesson again and again.
In the setting of medical school or residency surgical training, errors in judgment and technique are viewed as morally neutral, whereas failure to report or to correct them is viewed as more serious.3 The same moral imperatives should apply to out-of-hospital surgeries in private practice, which now account for more than half of all surgeries.
An ethical conflict of interest exists when a physician is motivated by self-interest at the cost of patients’ well-being. Potential surgical disasters must be identified and prevented to serve the best interest of patients. When medicine does not make a concerted effort to report and study iatrogenic surgical complications systematically, this suggests an unethical conflict of interest.
Disincentives to Report
A surgeon would be reluctant to report voluntarily a significant cosmetic surgical complication and thereby harm his own reputation. For less obvious reasons, a medical equipment manufacturer might be motivated to discourage surgeons from reporting surgical complications involving the manufacturer’s medical equipment.
The U.S. Food and Drug Administration (FDA) regulates the manufacturers of medical devices and equipment. If a manufacturer receives an official written notification of a surgical complication associated with one of the manufacturer’s devices, the manufacturer is required by law to notify the FDA about the mishap. If the manufacturer hears about such a surgical complication unofficially, such as during a casual conversation, the manufacturer need not report the event. An official report of a serious complication to the FDA may result in a time-consuming investigation, a reassessment of the device’s safety, and a restriction in sales. This is an incentive for manufacturers to remain ignorant about complications involving their equipment.
In California, county coroners and medical examiners are not required to cross-reference deaths resulting from a medical misadventure. Such cases are merely recorded by the name of the deceased. It is virtually impossible to obtain information from a coroner’s office about unknown patients who might have died from a specific category of causes. This subtle form of concealing data, which otherwise would be readily available, discourages researchers from studying the causes of death.
Deaths or severe complications of cosmetic surgery are usually not reported or discussed at open sessions of professional scientific surgical meetings. Fear of both embarrassment and loss of income may preclude some voluntary reporting. A central registry is needed for reporting deaths associated with recent ambulatory surgery and for collating information on possible iatrogenic complications.
No Central Registry
Research into the causes of airline accidents has shown that 70% of airline accidents involved some degree of human error. Most of these errors have stemmed from failures in communication, teamwork, and decision making rather than from technical shortcomings.4 Similarly, most surgical accidents involve some degree of preventable human errors resulting from incomplete knowledge, inadequate communication, and faulty decision making.
Professional airline pilots, without stigma or fear of personal consequences, are required to report confidential information about their mistakes and near-misses to a centralized agency. This agency routinely notifies other pilots about newly recognized problems and methods of prevention. No similar central registry exists for catastrophic surgical complications, and no effective mechanism encourages surgeons to report complications.
Almost all ambulatory surgery is performed on healthy patients, and the procedures are expected to be safe and uneventful. When a death does occur, it is likely to be associated with a preventable iatrogenic injury, such as drug interactions, genetic defects in drug metabolism, or preventable errors in surgical or anesthetic technique. Concerned physicians need a central registry that uses epidemiologic techniques to detect isolated events.
Every unexpected death of a healthy cosmetic surgery patient is presumably preventable. Preventable ambulatory surgical deaths should be subject to the same epidemiologic scrutiny as any other public health problem, as follows:
- Identify the existence of similar unexplained deaths.
- Methodically determine the probable causes.
- Institute preventive measures.
For ambulatory surgery the most formidable problem is identifying the existence of unexplained but similar deaths.
The obfuscation of medical mistakes and surgical catastrophes seems to be institutionalized. Virtually every institution in U.S. society seems to ignore the problem or actively impede the distribution of knowledge about factors associated with unexpected surgical fatalities.
More than half of all surgeries are performed in out-of-hospital facilities, but according to the Medical Board of California (MBC), no statistics are kept about the safety of these surgeries. The MBC does not maintain databases that permit the identification of all the deaths associated with ambulatory surgery. For example, the MBC denies being able to retrieve information on reported deaths associated with liposuction in a way that would allow epidemiologic analysis. The MBC apparently has made no effort to categorize, analyze, and report its extensive data on medical and surgical catastrophes.
County coroners also do not categorize their data on unexpected deaths in an epidemiologically useful manner. Autopsy reports from county medical examiners and coroners on deaths associated with “medical misadventures” are already part of the public record and should be available. The coroner’s office of Orange County, California, records deaths by the address where the death occurred. Deaths are not cross-referenced by cause or by attending physician. Furthermore, budgetary constraints may not allow a county coroner’s office to investigate all suspicious cases.
Hospital and Insurance Practices
When a patient dies in a hospital after ambulatory surgery, the death is reviewed by a committee of physicians on the hospital staff, but the relevant findings are usually not shared with interested outside physicians. The hospital peer review process is specifically designed to deny oversight or scrutiny from the public or from interested professionals who are not members of the review committee.
Malpractice insurance carriers deny being able to retrieve information about deaths associated with liposuction or ambulatory surgical deaths. These institutions possess comprehensive databases listing almost all fatal therapeutic misadventures. Because of statutory law, lack of insight, or simple indifference, these insurance companies publish no scientific data on ambulatory surgical deaths. These huge databases most likely possess valuable information that could be published as anonymous statistical summaries to help prevent surgical complications.
Physicians and institutions are not required to report deaths in ambulatory surgery to any state or national epidemiologic registry or database. Thus, in the United States, no scientific mechanism is available to collect and scrutinize data so that subsets of deaths with a common pattern of predisposing factors can be identified. Although California law appropriately requires the reporting of rare infectious zoonotic diseases and certain cancers such as cutaneous melanoma, preventable ambulatory surgical deaths are not reportable.
Death Certificate Data
California has death certificate regulations that are intended to provide epidemiologic data on preventable causes of death. At present, however, death certificate data on mortality associated with either outpatient surgery or outpatient anesthesia are not recorded. California death certificates do not require the attending physician to specify that death was associated with an injury sustained during an ambulatory surgical procedure. Typically, such deaths are simply listed as the result of a “cardiac arrest.” In 1995 the California Medical Association defeated a proposal that state death certificates must identify any death occurring within 30 days of an ambulatory surgery.
The National Center for Injury Prevention and Control (NCIPC) of the Centers for Disease Control and Prevention (CDC) has a surveillance program to identify head injuries related to bicycle riding, but it does not collect data on preventable injury associated with anesthesia or ambulatory surgery. When asked if the CDC/NCIPC could act as a registry for reporting fatal and potentially fatal events that occur during or soon after (within 30 days) ambulatory surgery, the director suggested that another, unspecified agency was responsible for the analysis and prevention of surgical injury.5
Better incentives are needed to encourage surgeons and anesthesiologists to report their outcomes, mistakes, and problems.6 The present system of voluntary reporting is inadequate; physicians responding to questionnaire surveys most likely underreport the incidence of serious injury and death associated with surgery.7-10 Surgeons must be required to report all such deaths. Government legislatures, state medical boards, malpractice insurance companies, and the medical profession must cooperate in formulating a nonpunitive policy toward reporting surgical complications.
Surgeons must be guaranteed anonymity to encourage them to share their experiences. Surgeons must be compelled to report cases without fear of committing professional suicide. Government agencies responsible for public health issues must provide epidemiologic analyses that present data in the form of statistical summaries, without revealing the names of individuals or organizations.
To protect the anonymity of individuals and institutions, access to initial case reports and raw data should be restricted. Research protocols using such data and publication of all research reports must be approved by an appropriate human subjects research committee.
The Ideal Solution
Ideally, to identify unrecognized causes of death resulting from surgery or anesthesia, each specialty would take full responsibility for reporting and analyzing each unanticipated death. This would require compulsory reporting, absolute confidentiality, and significant penalties for noncompliance. Ultimately, the systematic epidemiologic investigation and the reporting of statistical analyses would be required to ensure the anonymity of all participants.
Unfortunately, little evidence is available to suggest that any surgical specialty will soon institute a useful surveillance–quality assurance program.
A Realistic Solution
To identify the sources of preventable injury to patients and to evaluate the efficacy of government regulations for ambulatory surgical facilities, I would propose the following solution:
1. To facilitate epidemiologic analyses of preventable deaths associated with outpatient surgery or outpatient anesthesia, state medical boards and state medical associations should propose and support legislation requiring state death certificates to answer the following questions:
a. Was the death related to an outpatient surgery or an outpatient anesthetic misadventure?
b. Did the deceased patient have surgery at an ambulatory facility within 30 days before death?
2. Any death associated with outpatient surgery or outpatient anesthesia and any death within 30 days after ambulatory surgery must be reported to the local county coroner’s office. The surgical facility’s medical director, the surgeon, the anesthetist-anesthesiologist, and the director of nursing each must complete an epidemiologic death certificate questionnaire, designed jointly by the state medical board and the state department of public health.
3. The raw data from these questionnaires should be made available to state agencies and scientific investigators whose research projects have been approved by an institutional review committee on human research. These data must only be published or made available to the public in a summary or statistical form that does not reveal the identities of patients, physicians, or surgical facilities.
At present, minimal reliable epidemiologic data exist on deaths and serious complications associated with outpatient surgery. Until such data are available, surgeons and anesthesiologists will remain uninformed about measures and techniques that might prevent iatrogenic complications among ambulatory surgery patients.
Death certificates should require mandatory reporting of all deaths and serious complications that are either (1) related to an outpatient surgery or anesthetic misadventure or (2) associated with a death within 30 days of an outpatient surgery.
Surgeons and anesthesiologists should be allowed to report a death associated with outpatient surgery in confidentiality, without stigma or fear of personal consequences. They should encourage government legislatures, licensing agencies, state and national medical associations, and their own speciality societies to implement efficient and nonthreatening epidemiologic data collection systems.
- Casarett D, Ross LF: Overriding a patient’s refusal of treatment after an iatrogenic complication, N Engl J Med 336: 1908-1910, 1997.
- Leveson SH: Surgical deaths, Br Med J 296:4-5, 1988.
- Bosk CL: Forgive and remember: managing medical failure, Chicago, 1979, University of Chicago Press.
- Helmreich RL: Managing human error in aviation, Sci Am 276:62-67, 1997.
- Rosenberg M: Personal communication, Atlanta, 1997, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention.
- Cooper JB: Is voluntary reporting of critical events effective for quality assurance? Anesthesiology 85:961-964, 1996.
- Sanborn KV, Castro J, Kuroda M, Thys DM: Detection of intraoperative incidents by electronic scanning of computerized anesthesia records: comparison with voluntary reporting, Anesthesiology 85:977-987, 1996.
- Cullen DJ, Bates DW, Small SD, et al: The incident reporting system does not detect adverse drug events: a problem for quality improvement, Jt Comm J Qual Improv 21:541-548, 1995.
- O’Neil AC, Peterson LA, Cook FE, et al: Physician reporting compared with medical-record review to identify adverse medical events, Ann Intern Med 119:370-376, 1993.
- Rohrich RJ, Muzaffar AR: Discussion. Fatal outcomes from liposuction: census survey of cosmetic surgeons, Plast Reconstr Surg 105:447-448, 2000.