By Patrick O’Brien, General Counsel, American Med Spa Association (AmSpa)

Florida’s new plastic surgery law went into effect on July 1, 2023. The new law is focused on adding more oversight, rules and restrictions to gluteal fat grafting procedures, more commonly known as the Brazilian butt lift or BBL. In brief, the procedure involves removing fat by liposuction from the patient and then re-injecting it into another part of the body to achieve the desired aesthetic effect. For several years this procedure has been at the center of tragic deaths, major complications and unlicensed practice in Florida. We have covered some of these stories in the past:

• Port St. Lucie, Florida, Medical Clinic Shut Down, State Uncovers Fake Doctor Doing BBLs
• Multi-society Gluteal Fat Grafting Task Force Issues Safety Advisory
• Brazilian Butt Lift: Behind the World's Most Dangerous Cosmetic Surgery

This law, referred to as House Bill 1471, was passed to fight this public health issue. It goes about this by establishing new standards of practice and more robust enforcement mechanisms. Already, practices that provide office-based surgeries must register with the Department of Health and be periodically inspected. The new law adds provisions that will make it easier for licensing boards and regulatory agencies to crack down on unlicensed activity. This includes an expedited route for a board or regulatory agency to file an injunction against a non-compliant practice, and the immediate revocation of an office’s registration if they refuse an inspection.

The law adds new limitations on what treatments may be performed in an office. In order for any procedure to be performed in an office surgery setting, it may not:

1. Be expected to result in more than 10% blood loss;
2. Require major or prolonged intrathoracic, abdominal or joint replacement procedures, though laparoscopic procedures are permitted;
3. Involve major blood vessels or be performed with the open exposure of major blood vessels, though percutaneous endovascular intervention is excepted; and
4. Be emergent or life threatening.

Beyond this, the law’s main focus is to establish standards for gluteal fat grafting in office surgery settings. Assuming the procedure meets those limitations and can be performed in an office surgery setting, the physician then has certain requirements specific to gluteal fat grafting procedures. Prior to the procedure, the physician must conduct an in-person face-to-face examination of the patient, and this examination must be completed no later than the day before the procedure. Also, the physician must personally perform the fat extraction and re-injection; however, the physician may delegate tasks to others, provided the patient gives their informed consent and the physician provides direct supervision.

Per the new law, the gluteal injection of fat can only be made in the subcutaneous space and not cross into the fascia of the muscle. Intra- and sub-muscular fat injections are prohibited. To ensure that the injections are made into the appropriate area, the physician is required to use ultrasound guidance during placement of the cannula. The board may adopt rules that allow for alternate technology to be used, provided it is as good or better than ultrasound.

Physicians are limited to performing only one of these procedures at a time, and the office must have a one-to-one ratio of patients to physicians. And, once anesthesia has been administered to the patient, the physician may not start any other procedure until the patient has been extubated.

Laws, such as this, that only focus on a single procedure are very uncommon. Far more often, laws or rules regulate classes of treatments. A good example of this are laws pertaining to office-based surgeries, which regulate all surgeries that are performed in an office and have different requirements based on the risk or use of anesthesia. Usually, specifics are reserved for board-adopted administrative rules or policy statements. However, the state of Florida identified the risk from gluteal fat transplants as being great enough to warrant these special provisions.

The other notable part of the law is that it mandates the use of a specific technology. Many practitioners have already adopted the use of ultrasound in their cosmetic injecting practices. (AmSpa offers a course on it, too.) It is certainly a helpful technology to accurately place needles and cannulas, but, until now, its use had always been optional, prudent or good practice. Under this new law, ultrasound becomes the standard or minimum requirement when performing gluteal fat grafting. With this precedent, we may see ultrasound use be recommended or required more frequently by Florida and other states. We cannot be certain at this point if this law is the start of a new trend, where we will see laws with more detailed and specific standards of practice on particular procedures. But, we have seen in the past that public sentiment and news coverage often serve as a catalyst for legislatures to take action, and in this case, the large number of tragic news stories and reports of unlicensed or unqualified practitioners did help to draw attention to a major public health issue.