Emergency Office Surgery Rule: Now in Effect*
By Mary Thomas, Esq., FMA Assistant General Counsel | Originally published June 8, 2022; Updated June 16, 2022
As Florida remains a hotspot in the country for gluteal fat transfers, more commonly known as Brazilian Butt Lifts (BBLs), the prevalence of adverse incidents, including patient deaths, has continued. In March 2020, the Boards of Medicine and Osteopathic Medicine amended the office surgery Rules 64B8-9.009 and 64B15-14.007, respectively, to establish a standard of care for BBL procedures. The amended rule prohibited intramuscular or submuscular fat injections and clarified that “[w]hen performing gluteal fat grafting procedures, fat may only be injected into the subcutaneous space and must never cross the gluteal fascia.”
Unfortunately, BBL disciplinary cases are still coming before the Boards, prompting the promulgation of an Emergency Rule. This Emergency Rule makes two critical changes to the standard of care:
These changes are in effect as of June 14, 2022.
- Ultrasound guidance: The surgeon performing the BBL must use ultrasound guidance when placing and navigating the canula and injecting fat into the subcutaneous space. This is to ensure that the fat is placed above the fascia overlying the gluteal muscle.
- Procedure Limitation: Surgeons may not perform more than three BBLs in one day.
There are no exceptions to these standards and no grace period for implementation. Both the Board of Medicine and Board of Osteopathic Medicine have adopted identical Emergency Rules. This means:
The Emergency Rule will remain in effect for 90 days, during which time the Boards will initiate the formal rulemaking procedure to make these changes, or changes similar to the spirit of the Emergency Rule, permanent.
If you are an FMA member and have any questions or concerns regarding the Emergency Rule or pending rulemaking, please do not hesitate to contact me at email@example.com or (850) 224-6496.
- If your office does not have the equipment for ultrasound guidance, you must suspend BBL procedures until such time as the equipment is acquired.
- If you are not reasonably skilled at injecting fat while using ultrasound guidance or do not have a qualified sonographer available, you must suspend BBL procedures until such time that you or an assistant can perform this additional task safely.
- If you have more than three BBLs scheduled in one day, you must reschedule the BBL procedures in excess of the third BBL. The Emergency Rule does not limit the number of any other type of procedure that can be performed in addition to the three BBLs.
- This Emergency Rule only applies to BBL procedures performed in a registered office surgery facility. This rule does not apply to BBLs performed in other facilities such as a facility licensed under Chapter 395, Florida Statutes.
BOARD OF MEDICINE DRAFT
THE FULL TEXT OF THE EMERGENCY RULE IS:
64B8ER22-3 (64B8-9.009) Standard of Care for Office Surgery.
Nothing in this rule relieves the surgeon of the responsibility for making the medical determination that the office is an appropriate forum for the particular procedure(s) to be performed on the particular patient.
(1) No change.
(2) General Requirements for Office Surgery.
(a) through (e) No change.
(f) Standard of Care for Gluteal Fat Grafting. When performing gluteal fat grafting procedures, the surgeon must comply with the following standards:
fat may only be injected into the subcutaneous space and must never cross the superficial gluteal fascia. Intramuscular or submuscular fat injections are prohibited.
- Fat may only be injected into the subcutaneous space and must never cross the fascia overlying the gluteal muscle. Intramuscular or submuscular fat injections are prohibited.
- The surgeon performing the procedure must use ultrasound guidance when placing and navigating the canula and injecting fat into the subcutaneous space to ensure that the fat is placed above the fascia overlying the gluteal muscle. The surgeon must also maintain the ultrasound video recordings in the patient’s medical record including the time and the date stamp of the ultrasound video recording.
- A surgeon must not perform more than three (3) gluteal fat grafting procedures in one calendar day.
(g) through (p) No change.
(3) through (6) No change.
Rulemaking Authority 458.309(1), 458.328(2), 458.331(1)(v) FS. Law Implemented 458.328, 458.331(1)(v), 458.351 FS. History–New 2-1-94, Amended 5-17-94, Formerly 61F6-27.009, Amended 9-8-94, 11-15-94, Formerly 59R-9.009, Amended 2-17-00, 12-7-00, 2-27-01, 8-1-01, 8-12-01, 3-25-02, 3-22-05, 4-19-05, 10-23-05, 10-10-06, 4-18-07, 9-3-07, 3-25-10, 8-6-12, 11-22-12, 1-9-13, 3-3-13, 7-22-14, 4-6-15, 9-4-16, 5-22-17, 6-23-17, 9-4-17, 5-7-18, 7-2-18, 9-3-19, 3-2-20, 3-10-22.
THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE.
EFFECTIVE DATE: June 14, 2022
*Update: Since the FMA originally published this article, the Emergency Rule on Brazilian Butt Lifts has gone into effect. The information has been updated to reflect this change.