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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.
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