Fw: Mortality and Plastic Surgery

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From: " ilena rose " <ilena@...>

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Sent: Monday, February 04, 2002 7:42 PM

Subject: Mortality and Plastic Surgery

~~~ Very interesting ... Thanks Jean! ~~~

http://www.gasnet.org/societies/apsf/newsletter/2000/spring/02-morell.htm

OBA Questions, Problems Just Now Recognized, Being Defined

by C. Morell, MD

As we move into the 21st century, anesthesiologists and nurse

anesthetists will increase their participation in and experience with

office-based anesthesia (OBA).

To insure patient safety in the setting

of office-based anesthesia is a complex task. To even define the

issues that can impact patient safety is difficult. Many questions are

raised: What constitutes our concept of office-based anesthesia? Is it

restricted to general anesthesia with TIVA or potent agents or

regional anesthesia or does it include conscious sedation or the

infiltration of local anesthetics? Do the qualifications of the

individuals administering those varied forms of anesthesia influence

our concept of office-based anesthesia? Similarly, how much should we

be concerned with patient safety in the setting of office-based dental

anesthesia? Many of these issues may eventually become the subjects of

legislation and regulation. Attempts to do so have occurred in several

states including New Jersey, California, Texas, and Florida.

Successful legislation requires the establishment and enforcement of

regulations by authorities such as state medical boards to be

effective. Certainly the recent report by the Institute of Medicine1

has brought national legislative and executive attention to issues of

medical errors and patient safety. Right now is a golden opportunity

for the specialty of anesthesiology and groups such as the ASA and the

APSF to take a leadership role in examining these issues and helping

development of appropriate guidelines, recommendations and, where

applicable, standards of practice.

As much as some surgeons may talk about patient convenience regarding

access and surgeon convenience regarding scheduling, the real driving

force behind the increase in office-based anesthesia is largely

economic. Office-based anesthesia represents a potential for

cost-effective approaches for many surgical procedures. Cost

comparisons have demonstrated significant savings for office-based

surgical procedures compared to those procedures performed in the

hospital. For example, Schultz has reported that the cost of an

inguinal hernia repair done in the office setting was $895 compared to

$2,237 for the same procedure performed in the hospital.2,3 Lower

office overhead may also help to maintain profit margins, the forces

largely responsible for the growth in office-based anesthesia. In

fact, current estimates anticipate that between 20% and 25% of all

surgical procedures performed in the year 2001 will be in office-based

settings.2,4

Incidence of Adverse Events

The increases in office surgery and anesthesia will likely be

accompanied by increasing reports of adverse events and disasters. The

reports that have appeared do not allow calculation of the incidence

of adverse events, since the reporting of morbidity and mortality

following office-based procedures is not mandatory. Clusters do

occasionally surface, such as the 1999 report by Rao of five deaths

occurring in New York between 1993 and 1998 associated with the

technique of tumescent liposuction.5 During tumescent liposuction,

large volumes of dilute lidocaine and epinephrine containing solutions

are infiltrated subcutaneously. This solution acts as a hypotonic

" wetting " agent that lyses cell walls and emulsifies the fat. The

lidocaine is intended to provide local anesthesia and is generally

diluted to .05% - .1%. The epinephrine is prepared as 1mg/ml

(1:1,000,000) and provides vasoconstriction. Despite the dilute nature

of these solutions, the large volumes can lead to total lidocaine

dosages that exceed 65mg/kg. and total epinephrine dosages that reach

several milligrams.6,7 Assumptions have been made regarding the safety

of this technique based on slow absorption with peak serum levels

delayed some 12-14 hours after injection. The five deaths occurring in

New York including three deaths with precipitous hypotension and

bradycardia despite documented oxygen saturation levels of 97%-100% at

that time. This scenario is similar to that seen in animal studies

with intravascular infusion of toxic dosages of local anesthetics.

Other complications are also known to occur with tumescent liposuction

including pulmonary emboli, pulmonary edema, necrotizing fasciitis,

congestive heart failure, fat emboli and organ perforation. A survey

of 1,200 plastic surgeons revealed 95 deaths in nearly 500,000

liposuction procedures; yielding a mortality rate of approximately

1:5000.8 Despite a general lack of requirements for the reporting of

office-based morbidity and mortality (with the rare exception, such as

New Jersey), reports do make their way into the public domain. Since

1986, at least 41 deaths and over 1,200 injuries have occurred

following cosmetic surgery in Florida. Closed malpractice claims in

Florida have also identified 830 deaths and approximately 4000

injuries associated with office-based medical care occurring between

1990 and 1999. These office cases represent about 30% of the closed

malpractice claims occurring in that state.

The Closed Claims Project of the American Society of Anesthesiologists

has acquired seven claims related to office-based surgical anesthesia,

excluding pain clinic claims [personal communication from

Posner, ASA Closed Claims Project]. The entire closed claims database

contains 4459 standardized reviews to date. Five of these seven OBA

claims stemmed from incidents occurring between 1980-1989, the

remaining two claims occurred in 1990. Five of the office-based claims

involved death of a patient. The other two involved an eye injury and

an ICU admission following a difficult intubation (with full

recovery). All seven of the OBA claims received financial

compensation, with payments between $50,000 and $850,000 with a median

payment of $600,000. The mean patient age was 44, with an age range of

21-68. These patients were previously in good general health. The

procedures involved were three dental extractions, three cosmetic

surgical procedures, and one laser eye treatment. Care was judged to

have been substandard in four of the five deaths (80%) compared with

39% of hospital based claims. The substandard care issues included

esophageal intubation, malignant hyperthermia, and drug administration

error and airway obstruction. In one of the dental extraction cases,

the patient died following bronchospasm, but the care was judged

appropriate. There is generally a five-year lag time between the

occurrence of an adverse event and the subsequent claim resolution and

entry into the Closed Claims Database. Therefore, the adverse events

that are associated with the recent increase in office-based surgery

will not enter the database for several years.

Who are the Practitioners?

In 1997, non-plastic surgeons performed 50% of 250,000 liposuction

procedures. These individuals included dermatologists, primary care

physicians, emergency physicians, and, in some cases, unlicensed

individuals representing themselves as licensed physicians. Two

Florida ophthalmologists and one anesthesiologist have placed

advertisements offering breast augmentation surgery. Several dentists

have also been identified as performing hair transplants as well as

liposuction. Many of these practitioners have only had weekend courses

in cosmetic surgical techniques. Some have referred to themselves as

" board certified " after taking a 5-day course. In 1990, Oklahoma's

Board of Medical Licensure wisely refused to allow a cosmetic surgeon

to refer to himself as " board certified " after brief training by the

American Society of Cosmetic Breast Surgery. This was a decision that

was upheld by the Oklahoma State Supreme Court in 1993.9 In Houston,

Texas police arrested an unlicensed Chaves for illegally

practicing medicine and performing liposuction and cosmetic surgical

procedures at a beauty salon located within a shopping mall. He was

actually licensed as a cosmetologist. One " surgeon " used kitchen

utensils, purchased at a hardware store as his " surgical instruments. "

Who are the Victims?

A 27-year-old woman from Alabama died from respiratory failure shortly

after returning home from office-based breast augmentation. Her death

was believed to have been related to effects of sedation administered

during the procedure.

A 25-year-old Florida woman was discharged in a sedated state

following a six-hour office breast implant procedure. She was found

dead the next morning after taking one dose of an oral pain

medication.

A 28-year-old woman from Virginia Beach, Virginia, developed malignant

hyperthermia during office anesthesia for breast augmentation. By the

time she was transferred to an emergency room her temperature was 107

degrees. No dantrolene was available in the office setting. She

subsequently died.

A 51-year-old male underwent a 9.5 hour combined liposuction, penile

enlargement and facelift. Following the procedure he was kept in the

office overnight and monitored by a private duty agency nurse. Two and

one-half hours after surgery the nurse noticed he was in distress and

that the oxygen tank was empty. Paramedics were contacted 30 minutes

later. The patient was pronounced dead after transfer to a local

hospital 40 minutes later.

A San Francisco woman was recovering from an office-based facelift

received an injection of Demerol by a non-licensed individual who also

turned off the patient's cardiac monitor's alarm and then fell asleep.

The patient's death was one of the five deaths investigated by the

California Board of Medicine in the last two years that were

associated with cosmetic surgery.

A 3-year-old child from West Virginia underwent laser removal of port

wine stains by an emergency room physician assisted by a dentist. The

child had a seizure followed by cyanosis. No supplemental oxygen was

available in the office. Paramedics transported the child to an

emergency room of a local hospital where she subsequently died.

Five California children died during dental office procedures, four of

whom were given oral chloral hydrate.

A 50-year-old Florida man undergoing office-based facial cosmetic

surgery suffered a respiratory arrest. He was transported to a local

hospital by paramedics, but was comatose and eventually declared brain

dead. The medical examiner determined that his cause of death was

hypoxic brain damage.

Education

We can have an impact on this situation through education. We can

educate ourselves as to known pitfalls and dangerous scenarios, we can

educate other physicians through the literature and outreach programs

sponsored by our societies, we can educate legislators on areas that

are appropriate for regulation, and most importantly, we can educate

the public. Patients should be aware of the choices that they have and

the questions to ask before undergoing elective office-based

anesthesia and surgery. They must become educated consumers and, thus,

be protected from those who are selling beauty and convenience at what

may well be a very high price.

Dr. Morell is Director, Preoperative Assessment Clinic and Associate

Professor of Anesthesiology, Wake Forest University School of

Medicine, Winston-Salem, NC.

References

Kohn LT, Corrigan JM, son MS (eds). To Err is Human: Building a

Safer Healthy System. Committee on Quality of Health Care in America.

Institute of Medicine. Available at:

http://www.nap.edu/books/0309068371.

Lazarov SJ. Office-based surgery and anesthesia: where are we now?

World J Urol 1998;16:384-385.

Schulz LS. Cost analysis of office surgery clinic with comparison to

hospital outpatient facilities for laparoscopic procedures. Int Surg

1994;79:273-277.

Laurito CE. Report of Educational Meeting: The Society of Office-Based

Anesthesia, Orlando, Florida, March 7, 1998. J Clin Anesth

1998;10:445-448.

Rao RB, Ely SF. Hoffman RS. Deaths related to liposuction. N Engl J

Med 1999;340:1471-1475.

de Jong RH. Mega-dose lidocaine dangers seen in " tumescent "

liposuction. Anesthesia Patient Safety Foundation Newsletter.

1999;14(3):25-27.

Prielipp RC, Morell RC. Liposuction in the United States: beauty and

the beast. Anesthesia Patient Safety Foundation Newsletter.

1999;14(2):18-19.

Grazer FM, de Jong RH. Deaths from liposuction: census survey of

cosmetic surgeons. Plast Reconstr Surg 1999; In Press.

South Florida Sun-Sentinel Internet Website