U.S. Food and Drug Administration
FDA Consumer magazine
November-December 2000
Table of Contents
by Alexandra Greeley
A self-described athlete, thirty-year-old Jeanne Smith of Washington, DC, is fit, active, and happy. But like many young women, she has felt dissatisfied with her looks. Because she works in the medical field, Smith knows about its latest trends and techniques. So when friends talked about their satisfaction with liposuction, Smith already knew about the procedure and readily considered its pros and cons. She decided it suited her.
She wanted some body sculpting and knew what she was getting into. "I had basically the lower half of my body done, and it was pretty targeted surgery," she says. "I experienced drainage afterwards and that's normal. I stayed out of work for about one week, though I was active during that time. I went to movies, out to dinner ... but was not up to my 100-percent best."
That was more than one year ago, and Smith says she is happy with her new trimmer look.
Or consider the case of Robert F. Jackson, M.D., board-certified cosmetic surgeon of Marion, Ind., and chairman of the liposuction committee of the American Academy of Cosmetic Surgery. Himself a liposuction patient, Jackson had excess tummy fat--a potbelly, he calls it--removed. "The day after the surgery, I felt sore," he says, "but the pain was minimal." His surgery took place on Friday morning, and by Monday, Jackson was back at work.
These cases represent two of the many individuals who have helped make liposuction the most popular form of cosmetic surgery today. An estimated 287,000 procedures were performed in 1999, according to the American Society for Aesthetic Plastic Surgery. Liposuction has become the technique of choice for people who want an improved body shape, a body sculpted to reflect their own--and society's--ideals of physical beauty. Moreover, liposuction may be used in conjunction with facelifts, for chin and tummy tucks, and to reduce the size of abdomens, hips, and thighs.
"Most liposuction procedures are done for purely cosmetic reasons," says Lori Brown, Ph.D., an epidemiologist in the Food and Drug Administration's Center for Devices and Radiological Health. But she adds that some medical conditions, such as large breasts in men; lipomas, or fatty lumps; or fatty deposits like the buffalo hump--caused by hormonal imbalances that grow masses of fat on and around the neck--may be treated with liposuction.
But the rise in its popularity and changes in the techniques doctors use to perform liposuction have raised concerns within FDA. There is growing evidence that the increased aggressiveness with which the procedure is performed--especially the amount of tissue sucked from the body, the venues in which the procedures are performed, and the amount of anesthesia used to sedate patients during increasingly lengthy procedures--may be increasing the risk of post-surgical complications and even death.
How Liposuction Works
Conceptually, liposuction (or lipoplasty) is a straightforward technique in which excess fatty tissue is suctioned from beneath the skin. Prior to surgery, doctors flush the targeted area or areas with a solution composed of lidocaine (a local anesthetic similar in its numbing effects to novocaine), saline, and epinephrine (a drug that constricts blood vessels and thus reduces bleeding during surgery).
Then doctors insert a hollow wand-like device called a cannula through incisions in the skin. They push and pull the cannula around through fatty deposits, breaking up the cells, which, along with other body fluids, are suctioned out by an attached vacuuming device.
It's a simple system, says Stephen Rhodes, chief of the plastic and reconstructive surgery devices branch in FDA's CDRH. "It's essentially just a cannula and a vacuum." However, these products have only been approved for body contouring, and are not intended for large-scale fat removal, an increasingly popular use of liposuction.
There are several liposuction techniques available today. The amount of injected fluid determines the technique used, explains Peter B. Fodor, M.D., chief of plastic surgery at Century City Hospital in Los Angeles and spokesman for the American Society for Aesthetic Plastic Surgery.
In the "dry" technique, which few doctors use anymore, no fluid is injected into the targeted area.
For "wet" liposuction, the surgeon injects only a small amount of fluid, about six to eight ounces and usually containing small amounts of ephinephrine, regardless of how much tissue is subsequently removed.
The "superwet" technique evolved, says Fodor, because doctors found that the more fluid they injected--up to a point--the less blood was lost. "We found that by injecting one cc of solution for each cc of aspirate [amount of tissue and fluid removed], the blood loss was negligible." Although lidocaine is sometimes added when performing wet or superwet liposuction, patients will also receive general or epidural anesthesia.
In the tumescent technique, doctors inject up to five times as much fluid as aspirate. Because the injected fluid also contains large amounts of lidocaine, tumescent liposuction is generally performed with only a local anesthetic.
Many doctors are offering a modified version of the procedure that calls for using ultrasound in addition to the injected solution and the suctioning. Rhodes and others at the FDA are especially concerned about this practice, which calls for using devices not approved for liposuction--that is, special cannulas that vibrate at high rates and emulsify fat tissue before its removal. The wand generates a great deal of heat, and if doctors don't move it constantly, it can cause severe burns. As Roxolana Horbowyj, M.D., senior medical officer in CDRH, points out, a temperature increase of 20 degrees Celsius (about 36 degrees Fahrenheit) may encourage cell death. And, as FDA epidemiologist Brown notes, "We don't really know the long-term effects of ultrasound on tissues."
Understanding the Benefits vs. the Risks
In a society in which beauty is often measured by slender bodies and youth, it is no wonder that thousands of Americans chase the "perfect" look by means of liposuction. Portrayed in upbeat tones and associated with Hollywood glamour, liposuction seems to offer instant help for unsightly bulges. Consumers checking out liposuction Web sites on the Internet are further assured by the positive information they find.
"There are probably hundreds of thousands of patients who have had body sculpting without complications," says Ann Graham, senior nurse consultant in CDRH's Office of Surveillance and Biometrics. "But we are concerned about the published reports of patients who have not had a good outcome. They have undergone liposuction for weight reduction, not just body sculpting. Liposuction, in general, is a purely elective procedure. As such, our tolerance for an unsafe or harmful outcome is extremely low."
Although many consumers think of liposuction as a quick and permanent fix, it's likely that few understand its risks and frequently temporary results. There is no national group of consumers, nor one group representative of all clinicians, that is organized to oversee liposuction procedures and results. Although FDA is aware of problems published in medical literature and described by other sources, "very few adverse event reports are coming into the agency through its formal reporting channels" according to Anita Kedas, a nurse consultant in CDRH's Office of Surveillance and Biometrics. But the small number of reports may simply mean that negative outcomes aren't being reported.
Office-based procedures may present the greatest reporting problem. There's no requirement that adverse events from office procedures be reported, and most procedures are done in offices, according to Graham. Even if offices are well equipped, she adds, patients often need days of continuous support such as rehydration, pressure dressings, and good nursing care, while others actually need resuscitation and hospitalization to recover. And if a patient goes to the emergency room for care, FDA doesn't hear about it, adds Graham.
Whether reported or not, liposuction problems are real enough--though some, such as wavy or uneven skin after fat removal, are not medically serious.
But others are. Overworking the heart can be a serious side effect of the tumescent technique. "Let's say they plan to remove 5,000 cc's of aspirate," says plastic surgeon Fodor, "so they inject a dangerously large amount of fluid. The patient would be practically 'drowning' in fluids. The heart can't handle this fluid overload."
Another potential complication is infection, says Brown. Infections can occur after any surgery. Sometimes, infections may be serious or life threatening such as in cases of necrotizing fasciitis (when bacteria eat away at tissue) or toxic shock syndrome, a serious infection which has been associated with tampon use but may also be associated with surgery, says Brown.
Other possible problems Brown lists are burns, embolisms, cardiac arrhythmia, edema, and nerve compression, which are all reported in the medical literature. Often, too, Graham notes, cannulas are inserted in several different locations, resulting in puncture wounds that need to heal.
A condition called seroma, or an oozing or pooling of serum, or body fluid, may be a problem after the more aggressive ultrasound techniques during which some skin is detached from underlying tissue and fluid accumulates in a subcutaneous pocket.
Deaths and Liposuction
According to a survey conducted by the American Society of Plastic Surgeons (ASPS) of more than 1,500 plastic and reconstructive surgeons in January, 1999, the death rate of one in every 5,000 (or 20 out of 100,000) liposuction patients between 1994 and 1998 was much higher than anyone anticipated--higher even than death rates from traffic accidents. And higher than acceptable death rates from other kinds of surgeries, admits Jack Bruner, M.D., associate clinical professor of plastic surgery at the University of California, Davis, and chairman of the task force on liposuction for ASPS. Although the survey data are not considered scientific information, they are useful when establishing practice guidelines, and they led ASPS to recommend some practice changes when performing liposuction.
It is encouraging, Bruner says, that more recent statistics from The Doctor's Company, an insurance company located in California, show that no liposuction-related deaths have been reported there in the last 18 months. However, he notes, this survey only addresses what's happening among board-certified plastic surgeons, not with other doctor groups performing liposuction.
Deaths among liposuction patients can happen for a number of reasons, Bruner says, including thromboembolism, or a blood clot that forms in the deep veins of the pelvis or legs. "That can happen during any surgery," he adds, "and I wish I could say that it is always preventable, but it is not." Next, he cites perforation of the abdominal wall or bowels, the latter being especially serious. "If you perforate the bowel, there's a high mortality rate if it's not fixed in the first 24 to 48 hours," he says. Physicians are essentially blind as they perform liposuction because they can't see what is in front of the cannula, notes FDA's Horbowyj.
Finally, Bruner notes that shock and hemodilution, or diluting of the blood, may lead to a patient's death. This can occur when patients have had large amounts of fluids injected and then both fat and fluids removed, about 11 pounds worth in all during a larger-scale procedure.
Further, although virtually no hard data exist, says Bruner, he and others worry that too much lidocaine may also lead to death. Lidocaine use poses particular hazards, especially since experts do not agree on safe injectable levels. "If you get too much lidocaine for too long," says Bruner, "the heart muscles become lazy. On the other hand, the brain becomes very agitated at first, which may cause a seizure, before coma sets in."
At least one study links possible lidocaine toxicity to liposuction deaths, says Horbowyj, adding that people with less than normal liver function or those who have been drinking alcohol may not be able to metabolize lidocaine well.
After Surgery
Patients should expect discomfort post-surgery, says Graham. "Patients are bloated, have wounds all over, and are feeling distended."
Surgeons, says Bruner, should discuss such conditions with their patients beforehand. "We talk about excessive bruising and chronic and prolonged swelling," he says. Anytime there's an injury--and liposuction surgery is really a controlled injury--body fluid rushes to the site and the injured tissue becomes like a sponge, he explains. With liposuction, doctors have gone under the carpet of skin and have taken away the fat undercoating, so the raw surface oozes serum on the inside.
To control the swelling, Bruner has his patients wear a garment with elastic pressure, reaching from below the breast area to mid-thigh. "This gives good compression, and if we don't do that, the body swells up like the Michelin man," he says. The skin sticks to the undersurface, and as it starts to heal the fluid stops oozing and the swelling goes away. "At the end of three weeks, 90 percent of the swelling and bruising are gone," he says, although patients may wear the elastic garment for up to six weeks.
Is Liposuction for Everyone?
Many people develop stubborn fatty deposits--like in the buttocks or upper thighs, or the so-called "love handles"--that are resistant to dieting and exercise. And although most people would admit to wanting to reshape their body in some way, not everyone makes an ideal liposuction candidate, says Daniel Morello, M.D., president of the American Society for Aesthetic Plastic Surgery. Morello stresses that liposuction is for body contouring, not weight reduction. "It is designed for removing localized areas of fatty tissues--not as a substitute for proper dietary management and exercise."
But what happens to the mildly to seriously overweight people who want and get liposuction? Sometimes after the surgery, these people may face yet another unwanted--and possibly unexpected--complication: the return of fatty deposits, but probably in other areas of the body, says C. Wayne Callaway, M.D., an associate clinical professor of medicine at George Washington University. Callaway, who is also an internist, endocrinologist, and obesity specialist in Washington, D.C., sees post-liposuction patients complaining of renewed accumulations of fat.
Animal studies have shown that if you remove significant amounts of fat from one area, body fat increases elsewhere, according to Callaway. "The signal is leptin, a hormone made in fat cells," he says. "The more fat you have, the more leptin is made ... and if a large amount of fat is removed, there is a drop in leptin levels." In animal studies, this drop in leptin levels results in an increase in food intake and a decrease in activity until the leptin levels are up again, according to Callaway.
Callaway says that the people who have the most trouble after a liposuction procedure are the really obese who have had large amounts of fat removed. "They have a compensatory increase in new fat cells," Callaway says. "And fat goes to areas where there are still a lot of fat cells. So that means to the neck, above collar bones, and the upper abdomen." Besides, he adds, abdominal obesity is controlled by a whole other set of signals, so that even after liposuction, the underlying causes for obesity remain. "Those causes are not addressed by taking out fat cells." He points out that, contrary to recent theories, "One can keep making new fat cells throughout life, so little can be gained by liposuction."
Liposuction for obese patients is "a prescription for disaster," according to Gerald Imber, M.D., a plastic surgeon in New York City and clinical assistant professor of plastic surgery at Cornell-Weill Medical College. The greater the volume of fat and tissue fluids, including plasma, that are sucked out, the greater the chance of severe dehydration and electrolyte imbalances. "When you remove six, eight, or ten liters of mixed fat and water, you are courting disaster," he says. "Liposuction is not meant to change a size 16 to a size 8."
According to a consensus of the experts, the ideal liposuction candidate is a mature adult between the ages of 30 and 50 years old, male or female, in good health, who has dieted and exercised to lose unwanted pounds, with good skin tone, with a set of realistic expectations, and who wants a limited procedure for body contouring.
Buyer Beware
Anyone considering liposuction should consider all the options, and consumers need to be very careful when selecting a doctor. The saying "caveat emptor" (buyer beware) has never been truer, says Morello. Liposuction sounds so deceptively simple, but in the hands of unskilled doctors, it poses a real threat to people's health, he adds. To complicate matters, anyone with a medical degree can perform liposuction, even with only the briefest weekend training period.
Fighting fat may be the number one battle for many Americans, but liposuction may not be the best weapon to win that slimmer, trimmer body.
Alexandra Greeley is a writer in Reston, Va.
The American Society for Aesthetic Plastic Surgery, offers some guidelines for consumers considering liposuction:
--A.G.
Health professionals or consumers should report serious adverse reactions or other problems related to equipment or medications used for liposuction through FDA's MedWatch program (See "Serious Product Problem? Report It.").
The Safe Medical Devices Act of 1990 requires hospitals and other user facilities to report deaths, serious illnesses, and injuries associated with the use of medical devices. Questions about mandatory reporting can be answered by the Division of Surveillance Systems, Reporting Systems Branch, by phone on 301-827-0361, or write to FDA, CDRH, MDR User Reporting (HFZ-531), PO Box 3002, Rockville, MD 20847-3002.
A.G.
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