This post was originally published on Law360.com
By Dan McKay
Law360 (September 24, 2024, 1:06 PM EDT) — A spate of patient deaths following a gluteal fat graft—otherwise known as a Brazilian butt lift—has the attention of lawmakers and regulators in Florida, the epicenter of a booming plastic surgery business focused on patients seeking an “hourglass” figure.
Twice in the last two years, Florida has tightened its laws on the lifts to establish unusually specific requirements on where the procedure may be conducted, how to carry it out, and the liability coverage physicians must secure to do it legally.
The Sunshine State’s debate over regulating the elective surgery is expected to ripple through other parts of the country in coming years if the procedure continues to grow in popularity.
“Florida is kind of the canary in the coal mine and a bit of a bellwether state,” said Dr. Andrew Rosenthal, a member of the American Society of Plastic Surgeons and president-elect of the Florida Society of Plastic Surgeons. “We get a lot of legislation passed here, and it becomes a template for other states.”
The new laws follow a series of deaths in South Florida, where 25 fatalities related to the Brazilian butt lift occurred between 2010 and 2022, according to the Aesthetic Surgery Journal.
One of the risks of the procedure, often referred to as a BBL, is that pieces of fat can be sucked into a vein, travel to the lungs, and cause a pulmonary embolism—a complication the new laws are designed to address.
The scrutiny facing cosmetic surgery in Florida isn’t limited to legislation.
Magda C. Rodriguez, a Miami-based partner at Day Pitney LLP, said she’s spotted increased enforcement activity by the state Department of Health and others to ensure compliance with the new laws and regulations, which require inspections and registration with the state.
Business owners and doctors “need to know these laws and these regulations and know that the department and the Legislature are hyper-focused on cutting out any loopholes to ensure patient safety during these procedures,” she said.
The legislation itself includes detailed requirements on where the fat may be injected during a Brazilian butt lift, the use of ultrasound technology to guide the procedure, and other standards of care.
Such specific standards rarely make it directly into state medical law, experts say, and point to how closely policymakers in Florida are watching cosmetic medicine.
“This is quite extraordinary,” said Katherine Drabiak, a legal scholar at the University of South Florida and professor in its colleges of public health and medicine. “We don’t see this in other areas of the practice of medicine.”
Deaths Linked to Lifts, Then Legislation
Nationally, cosmetic procedures climbed about 5% last year over 2022, according to a recent report by the American Society of Plastic Surgeons. Florida plays an outsized role in the cosmetic surgery industry.
The state had the most plastic surgeons per capita in the U.S., according to a 2020 study. Miami—a mecca for those seeking a new look that also hosts a major annual “aesthetics” conference at a beachside hotel—is a particular hot spot.
“We are the Sunshine State. People come from all over the world for plastic surgery here,” said Mitchell Panter, managing partner at Panter Panter & Sampedro PA in Miami, where he has sued on behalf of patients harmed in surgery.
South Florida grabbed attention in recent years for patient deaths associated with Brazilian butt lifts. It had by far the nation’s highest mortality rate for the procedure, according to legislative documents.
The procedure—in which fat from the abdomen or other parts of the body is removed through liposuction and injected into the buttocks—has been the fastest-growing type of aesthetic surgery over the last decade, the Aesthetic Surgery Journal said last year.
Some female social media influencers and celebrities, such as singer SZA, say they’ve undergone the procedure. Supporters say it improves the shape of the patient’s body.
The multistep procedure is largely sought out by women, though some surgeons say they routinely provide the surgery to male patients, too. The average cost of the surgery itself is about $7,264, according to the American Society of Plastic Surgeons, though the base price may not include the cost of anesthesia, facilities fees, and other expenses.
Rosenthal, the plastic surgeon, said much of the safety concerns in Florida centered on a section of Miami where businesses—many not owned by doctors—set up factory-like environments to handle large volumes of patients. A surgeon would arrive, do a few procedures, and then leave, he said.
“People were dying and being harmed and maimed,” Rosenthal said.
Surgeons and medical groups on their own took steps to develop best practices intended to maximize the safety of patients, he said. They also pushed for legislative action, resulting in the passage of H.B. 1561 this year and H.B. 1471 last year.
The new measures require state inspections and registration before Brazilian butt lifts can take place in an office setting.
They also require doctors to conduct an in-person exam of the patient at least a day before the procedure. Doctors also must handle the most important parts of the BBL rather than delegate it to other employees, and they can serve only one patient at a time.
Under the regulations, providers are prohibited from injecting fat into the muscle. Instead, fat must go into an area just below the skin, with ultrasound technology helping guide the placement.
The measures also set financial responsibility requirements for doctors. They generally need $250,000 in liability coverage for a claim and annual coverage of at least $750,000.
A ‘Lucrative Industry’
The legislation may make it easier for plaintiffs to bring successful medical malpractice claims, given that the required standards of care are explicitly outlined in state law, Drabiak of USF said.
That doesn’t necessarily mean that many doctors have been willing to rush through procedures or violate the accepted standards of care.
“It’s important to emphasize that most physicians will do everything to minimize risks to their patients—not only because they’re trying to make sure that their patients have a good surgical outcome, but they also don’t want to get sued,” Drabiak said.
“I think it’s a very small percent of physicians that are kind of operating in this model, doing the procedures in ways that could compromise patient safety or quickly doing the procedures.”
The liability requirements may also provide some accountability by ensuring doctors have insurance coverage to handle claims against them.
Panter, the Miami plaintiffs attorney, said some of his clients have been unable to collect even after securing multimillion-dollar judgments. Doctors “bury themselves under corporate structures,” he said. “It’s ridiculous how they’re avoiding the law.”
Panter said it’s good to see Florida taking steps to better regulate the industry, though the practical impact remains to be seen. “Whether it’s actually going to do anything, I hesitate to say, ‘yes,'” he said.
Rodriguez of Day Pitney said it’s vital for business leaders in the cosmetic surgery industry—many of whom aren’t doctors themselves—to keep up with the legislation and regulations.
They should be prepared for high-stakes inspections and understand the consequences of losing their business registration, among other potential penalties. After a shutdown, it isn’t as simple as just hanging a new shingle.
“You can’t close one down and open one across the street with the same individuals that were on the original application,” Rodriguez said.
Increased enforcement is likely to continue but likely won’t halt the growth in cosmetic medicine.
“I think this is a very lucrative industry,” Rodriguez said. “I don’t foresee these amendments to the laws or regulations slowing the industry down.”
Doctors have their own incentives for practicing cosmetic medicine. The financial pressures they face after the cost of medical school makes it attractive, said Rosenthal, who practices in Palm Beach County.
Medicare reimbursement cuts and other factors have cut doctors’ pay in inflation-adjusted terms, he said, making it tougher for physicians to survive without being part of a larger group or hospital.
“It’s become very difficult to practice non-cosmetic medicine in this country,” Rosenthal said.
As the industry grows, Rosenthal said, other states are likely to weigh legislation similar to Florida’s.
“Nobody wants to see patients get harmed,” he said.
–Editing by Haylee Pearl.
Update: This story was updated to better describe the location of Dr. Andrew Rosenthal’s practice.
