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?No Smoking Gun? Points to Tighter Regulation of Office-Based Cosmetic Surgery, Report Researchers at Wake Forest University Baptist Medical Center

WINSTON-SALEM, N.C. – Researchers found “no smoking gun” to support tighter regulations on cosmetic surgery performed in physician offices, a team from Wake Forest University Baptist Medical Center reports today in Dermatologic Surgery.

“We found there was really very little in the way of adverse events related to dermatology,” said Steven R. Feldman, M.D., Ph.D., professor of dermatology at the Medical Center and a co-author of the study. “Right now the data certainly don’t suggest that there is rampant misconduct in physicians’ offices.”

In their report, “No Smoking Gun: Findings from a National Survey of Office-Based Cosmetic Surgery Adverse Event Reporting,” Feldman and colleagues recommend that all states adopt standardized and mandatory reporting of patient complications so that any future policy aimed at patient safety can be based on solid evidence. “Unfortunately, the data being collected aren’t very comprehensive,” Feldman said in an interview.

The national survey was a response to the growing popularity of office-based cosmetic surgery; highly publicized cases involving patient deaths; and the movement afoot in some state legislatures to adopt new regulations in the name of patient safety.

After identifying appropriate agencies, researchers asked about cases of patient injury or death resulting from any cosmetic surgical procedure—including any form of liposuction, the most common of the cosmetic surgical techniques—that occurred in an office setting from January 1999 through December 2001 in the 48 contiguous states.

Five states reported 13 adverse outcomes: Florida had eight cases including three deaths; Oklahoma, two cases of death; Pennsylvania and New Mexico, one case each of death; and Utah, one case. But the total number of procedures was not available, which means researchers could not calculate the rate of adverse outcomes.

Thirty states reported no adverse outcomes during the study period. The other 13 states either had incomplete information or were unable to provide information about adverse outcomes resulting from office-based cosmetic surgery procedures. They are Arizona, California, Delaware, Kansas, Maine, Maryland, Massachusetts, Missouri, Nevada, New Jersey, New York, Ohio and South Dakota.

Of the 13 adverse events, nine involved board-certified plastic surgeons; one an ear, nose and throat specialist whose certification was not known; and three physicians whose specialties were not known. No patient data were provided in eight of the cases. Thus researchers could not draw conclusions about whether the procedures themselves were appropriate or the impact of what type of anesthesia was used.

“We would like to see a system in place that encourages complete and accurate reporting so that we can make regulations that are truly helpful for improving patient safety,” Feldman said. “Right now there’s the desire to act, but the data aren’t there to come up with logical proposals. And some of the proposals that have been made seem to fly in the face of what limited data we have.”

Typical, he said, are proposals to limit the procedures that can be performed in physician offices, or to require that physicians who perform office-based procedures also have surgical privileges at a local hospital. “But if you look at the data from Florida, the one state where they do collect fairly comprehensively data on adverse events, most of the adverse events occur in the offices of physicians who are board certified; most of the adverse events occur in the offices of physicians who do have hospital credentials. Requiring physicians to get those credentials doesn’t seem to answer the real question.”

Co-author Rajesh Balkrishnan, Ph.D., formerly of Wake Forest but now at The University of Texas Health Science Center at Houston, agreed in a joint interview that it would be wrong to set new policy on the basis of incomplete or poorly collected data. “We need to make sure that we have systems in place which are collecting data in a uniform way and using the evidence to inform policy in a proper way,” he said.

Wake Forest University Baptist Medical Center is a health system comprised of North Carolina Baptist Hospital and Wake Forest University School of Medicine that operates 1,291 acute care, rehabilitation and long-term care beds.

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Media Contacts: Karen Richardson, (krchrdsn@wfubmc.edu) or Shannon Koontz (shkoontz@wfubmc.edu) at (336) 716-4587.

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