Harlan Pollock, a Dallas plastic surgeon and past president of the American Association for Accreditation of Ambulatory Surgery Facilities, says Texas' law doesn't go far enough to protect patients.
When offices register with the state of Texas, certain requirements kick in for the safe administration of anesthesia, according to Texas Medical Board spokeswoman Leigh Hopper. These include the presence of a doctor and another person certified in treating cardiac arrest and a "crash cart" containing life-saving equipment. But Pollock says these requirements apply only to anesthesia and have little to do with the safety of the surgery itself. Accreditation, on the other hand, would require sterile procedures, physical requirements for the operating room, safety equipment and thorough record-keeping procedures, Pollock says. Sterile procedures are key for infection control, which was what Maryland officials found lacking at Monarch Medspa, medical experts say.
This kind of "an out," in Pollock's words, means "The public has no real assurance that the facility is an adequate facility, and that is disturbing and a real concern," he says.
On Nov. 30, the Texas Medical Board barred Molina from ever performing surgery or dispensing controlled substances, a category that includes some pain medications, such as those with codeine. But Texas has done little to crack down on the offices and med spas where doctors like Molina practice cosmetic surgery, say plaintiff attorneys and plastic surgeons.
Hopper emphasizes that Texas' medical board "rigorously screens" doctors who apply for medical licenses. And once they have these licenses, doctors are required to meet what's known as the generally accepted standard of care no matter what area they practice in, she says.
Still, if Texas' state Legislature wanted to address office-based surgery, Robinson says, the board would "be happy" to implement any new rules.
LeCroy isn't the only Texas patient to suffer after cosmetic surgery in a doctor's office or med spa. The Texas Medical Board also found OB/GYN Barbara Marino didn't meet the "standard of care," have emergency procedures in place or maintain a sterile operative facility during liposuction on patients at Medspa 21 in Houston. One died two days after his liposuction, and an autopsy report said the cause of death was "acute toxicity" from the combined effects of four medications, including a patch for the pain medication Fentanyl, according to the medical board's records. Another patient had excessive levels of pain medicine, the board said.
Late last month, Marino was ordered to observe at least 30 hours of cosmetic surgery by a board-certified plastic surgeon and document other procedures for treating at-risk patients and dealing with emergencies. She did not respond to calls seeking comment.
In November 2011, Laura Bennack, an emergency room doctor who owns Radiance MedSpa in San Antonio, had her practice put under the supervision of another physician by the Texas Medical Board. It had investigated the treatment of 10 cosmetic surgery patients and found she didn't meet what it considers the appropriate "standard of care" or keep adequate surgery records. According to the board's disciplinary order, Bennack performs tummy tucks, liposuction and breast augmentation while patients are awake. The board said in an order in February 2010 that Bennack acknowledged her medical recordkeeping was "sparse at best." Bennack did not respond to calls seeking comment.
Med spas typically offer only procedures without anesthesia or under local anesthesia, which isn't regulated in Texas or many other states. "There is absolutely no regulation of med spas," Pollock says. "That's something that to me is very frightening."
Some doctors, including Marino and Molina, register their facilities for higher levels of anesthesia. Several states require accreditation for offices intending to use deep sedation or general anesthesia, since it is the type used for the most serious procedures, says Tampa anesthesiologist Hector Vila. But doctors can get around the law by registering for a lower level of anesthesia or using large volumes of local anesthesia, says Vila.
Vila says existing laws need to be more strictly enforced to ensure people don't continue to skirt them. Performing surprise inspections and more frequent inspections could be one way to accomplish this, he says.
Some of the toughest laws:
Florida. The state changed its law early this year to authorize the state to inspect any facility, including med spas, that remove more than 1,000 cc's of fat during liposuction. That would cover all but the most minor procedures, says Democratic state Sen. Eleanor Sobel, who introduced the bill. Previously, the inspection authority existed only for facilities that accepted Medicare or other insurance. The law was passed after two women died of an overdose of lidocaine, a local anesthetic similar to novocaine, after liposuction.
California. Under a law passed in January, California's medical board keeps a list of accredited outpatient surgery settings. The board approved four accreditation agencies that inspect and accredit outpatient surgery settings, including medical offices and spas. These agencies can reject, revoke, or otherwise restrict a facility's accreditation. If that happens, the medical board is notified and alerts the public on its website.
New York. Any office-based surgery facility that removes more than 500 cc's of fat during liposuction or uses anything more than minimal sedation must be accredited. Still, even though New York has some of the most stringent regulation of office-based surgery, any licensed physician can perform cosmetic surgery under a local anesthetic in an unaccredited facility, says Manhattan plastic surgeon Adam Schaffner. "My hope is that they will require that physicians who perform such procedures perform them in accredited facilities (and) that they have hospital privileges for any procedure they perform outside the hospital," says Schaffner.
The issue of med-spa regulation is "absolutely rising to a national level everyone is really looking at it right now," says Robinson.
"Every single person needs to pay attention to the training of the person who's doing the procedure and the status of the facility -- whether it's accredited or not," says Sharfstein. "What you find out can make the difference between life and death."
Contributing: Yasmeen Abutaleb, Sarah Meehan
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