The Hialeah clinic where a 29-year-old West Virginia woman suffered fatal complications from a fat transfer procedure failed to properly monitor patients under general anesthesia and in some instances neglected to perform preoperative medical screenings in violation of state safety standards, according to Florida Department of Health records from an inspection conducted in January.
State inspection records list numerous failures at Encore Plastic Surgery at 1738 W. 49th St. in Hialeah, including shoddy record keeping and substandard equipment, in the months prior to the death of Heather Meadows, a mother of two who traveled to South Florida from West Virginia for an undisclosed surgical procedure that led to her death on May 12.
Inspection findings at Encore include:
▪ No evidence of preoperative medical screenings, such as an electrocardiogram, required to be performed on all patients 40 or older for certain surgeries;
▪ Improper monitoring of vital signs for a patient under general anesthesia, which was performed every 30 minutes instead of the required 5-minute intervals during a surgery that lasted 2 1/2 hours;
▪ Medical assistants signing off on patient assessments, including heart and lung screenings, with no indication that the surgeons required to perform those tests actually did so;
▪ Surgery consent forms missing requisite information, such as time stamps indicating patients had signed them before being anesthetized, descriptions of the procedure to be performed, and the specific anatomical areas for liposuction.
If an office surgery center is not wholly owned by a licensed physician, then the Florida Board of Medicine cannot take emergency action to restrict surgeries or close the center after a patient’s death.
Encore’s administrator, Estrella Rojas, did not respond to requests for comment sent through the clinic’s answering service and the office voice mail. Rojas signed a corrective action plan submitted to the health department on Feb. 25 and she is responsible for ongoing compliance, according to the document.
On Tuesday, the Miami-Dade Medical Examiner Department released a full autopsy report for Meadows establishing the cause of death as fat clots in the arteries of her heart and lungs due to complications from a fat transfer procedure.
According to the autopsy, Meadows also had a medical condition that contributed to her death. The condition is known as patent ductus arteriosus, which leads to abnormal blood flow between the aorta and pulmonary artery, two major blood vessels that carry blood from the heart.
The autopsy report does not identify the surgeon who operated on Meadows, nor does it indicate whether Meadows was placed under general anesthesia.
But the state’s inspection report cites at least nine occasions in 2015 when three surgeons at Encore placed patients under general anesthesia — a practice that some physicians say is more dangerous than operating with a local anesthetic, and more likely to lead to injury and even death.
The inspection report cites the three surgeons — Orlando Llorente, James McAdoo and Osakatukei “Osak” Omulepu — for allowing assistants to document preoperative medical screenings, which were then signed by the physicians with no indication that the doctors had performed the tests.
Llorente, McAdoo and Omulepu did not respond to requests for comment sent via email on Tuesday.
According to the state’s report, all three physicians also failed to indicate the time when patients had signed consent forms, while inspectors found that some forms had been significantly crossed out and written over by Encore staff.
75 Deaths in Florida from March 2000 to July 2014 related to office surgeries
In addition, a health department inspector found that Encore only provided back-up power for one of two operating rooms even though at times they are used simultaneously.
Tom Fiala, a plastic surgeon and president of the Florida Society of Plastic Surgeons, said the inspection findings do not demonstrate best practices.
“At the very least,” Fiala said, “it’s very sloppy that things like EKGs (electrocardiograms) weren’t done on people over 40, or if the doctor or physician or anesthesiologist didn't check the EKG and things like that before surgery.”
The inspection findings also may be indicative of how high-volume cosmetic surgery centers, which some medical professionals liken to an assembly line, place patients under general anesthesia more as a matter of efficiency than safety.
Brett Coldiron, an Ohio dermatologist and past president of the American Academy of Dermatology, has monitored the safety of office-based surgery in Florida for the last 15 years and said that, “In general, it’s incredibly safe.”
Coldiron and colleagues have yet to publish the 15-year findings. But he provided data tables showing that of the 75 patient deaths in an office surgery setting recorded in Florida from 2000 to 2014, at least 34 were due to cosmetic procedures — and about 38 percent, or 13 of those deaths involved patients getting liposuction under general anesthesia. The other deaths stemmed from medically necessary procedures.
It’s very sloppy.
Tom Fiala, Florida plastic surgeon
However, Coldiron said, “If you’re in the office setting and you’re using nothing but a local anesthetic, it's very hard to kill someone. ... It’s very difficult to perforate something important, like an organ, under local anesthesia because it hurts.”
Coldiron said he only uses local anesthesia on his patients, but that high-volume cosmetic surgery centers typically prefer to use general anesthesia because it acts faster than a local anesthetic and allows surgeons to operate on more patients in a shorter amount of time.
“They move from room to room to room because it's more remunerative than to wait for the local anesthetic to settle,” he said.
Fiala of the Florida Society of Plastic Surgeons said the state generally does a good job of regulating office surgeries — a sentiment echoed by Coldiron — but that the group is working on model legislation to tighten oversight of such centers.
“Most consumers really don’t know the difference between a well-qualified place and one that’s a fly by night,” he said. “If the marketing looks good … then patients just assume everything is in place, and as we’ve seen that’s not always the case.”