22067905, 64B15ER19-2 - Florida Administrative Rules, Law, Code, Register

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Notice: 22067905

Notice of Emergency Rule

Department:

DEPARTMENT OF HEALTH

Division:

Board of Osteopathic Medicine

Overview

RULE:

64B15ER19-2

Standard of Care for Office Surgery

SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE:

The Board of Osteopathic Medicine (hereinafter the “Board”) has statutory authority to set standards of practice and care for various practice settings.  Pursuant to this authority, the Board has promulgated rules setting forth standards of practice and care for office surgery settings where cosmetic surgeries are commonly performed.  
During recent years gluteal fat grafting, commonly referred to in marketing literature and the media as the “Brazilian Butt Lift,” has become a popular cosmetic procedure in Florida and around the world.  It is a procedure, commonly performed in office surgery facilities, where a surgeon removes fat from an unwanted area such as the abdomen or thighs and inserts the fat into the patient’s buttocks to enlarge and recontour the buttocks.  Unfortunately, this procedure has been connected to numerous patient deaths.   
This matter first came to the full Board of Medicine’s attention through disciplinary action taken against a physician who performed gluteal fat transfers in an office surgery facility that resulted in multiple adverse incidents including patient deaths.  There was also a Department of Health emergency restriction order precluding a physician from performing gluteal fat transfers pending outcome of final agency action.  Both physicians performed gluteal fat transfers that resulted in patient injuries and deaths.   The Board of Osteopathic Medicine has reviewed the relevant Final Order and an Administrative Complaint involving these physicians that resulted in patient injuries and death.  
The Board has also reviewed medical journal articles and practice advisories that found a higher mortality rate associated with gluteal fat grafting than with any other aesthetic surgical procedure.   The first such journal entry titled Report on Mortality from Gluteal Fate Grafting: Recommendations from the ASERF Task Force was published online in the Aesthetic Surgery Journal on March 21, 2017.  It reported the result of a survey conducted of 692 surgeons who performed 198,857 gluteal fat grafting procedures throughout their careers.  The surgeons reported 32 fatalities from pulmonary fat emboli and 103 nonfatal pulmonary fat emboli.  They further reported that the practice of injecting fat into the deep muscle resulted in a significantly increased rate of fatal and nonfatal pulmonary fat emboli.  
On January 31, 2018, the American Society of Plastic Surgeons published a Gluteal Fat Grafting Advisory from the Inter-Society Gluteal Fat Grafting Task Force.  The Task Force, made up of the American Society of Plastic Surgeons (ASPS), the American Society for Aesthetic Plastic Surgery (ASAPS), the International Society of Aesthetic Plastic Surgeons (ISAPS), the International Society of Plastic & Regenerative Surgeons (ISPRES) and the International Federation for Adipose Therapeutics and Science (IFATS), analyzed deaths from gluteal fat grafts and found that a death rate of approximately 1/3,000 patients is the highest for any aesthetic surgical procedure.  The Task Force also found that all the autopsies of deceased gluteal fat grafts patients revealed fat in the gluteal muscles, fat beneath the muscles, damage to the superior or inferior gluteal vein, massive fat emboli in the heart and/or lungs, and two instances of deaths or injuries with fat only in the subcutaneous space.  
The January 31, 2018, advisory was followed up by another on July 11, 2018, also from American Society of Plastic Surgeons, wherein the Inter-Society Gluteal Fat Grafting Task Force reported that deaths from gluteal fat grafting procedures continue to be reported wherein the cause of death is uniformly from fatal fat embolism caused by fat entering the venous circulation associated with injury to the gluteal veins.  The Task Force further found that in every gluteal fat graft patient who has died, at autopsy, fat was seen within the gluteal muscle. 
The findings from the aforementioned advisories and journal article were reinforced by the testimony and comments of interested parties that attended the Joint Board of Medicine and Board of Osteopathic Medicine Surgical Care/Quality Assurance Committee meeting on June 6, 2019, where the Board discussed and considered a rule setting forth a standard of care for gluteal fat grafting.    Representatives from the Florida Medical Association, the Florida Society of Plastic Surgeons both supported proposed rule language setting forth a standard of care for gluteal fat grafting that prohibits the insertion of fat into a patient’s buttocks that crosses the superficial gluteal fascia.  Gary M. Brownstein, M.D., F.A.C.S., a plastic surgeon, Chief Executive Officer of the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) and Chair of AAAASF’s board, also supported the proposed rule and clearly stated that inserting fat beneath the gluteal fascia is likely to cause harm and even death to patients.  
The Board does not believe that an outright ban on gluteal fat grafts is necessary, but it does believe that continuing to allow gluteal fat grafts that include intramuscular or submuscular injections of fat would present an immediate danger to the health, safety and welfare of Florida’s patients.    Accordingly, the Board, by emergency rule, establishes a standard of care for gluteal fat grafts that allows the injection of fat into the subcutaneous space.  The crossing of the superficial gluteal fascia, however, will be prohibited as well as intramuscular or submuscular injections of fat.   The Board is of the opinion that its actions are a measured regulatory approach that protects Florida’s patients while maintaining the availability of this popular aesthetic surgical procedure.

REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES:

The procedure used for the promulgation of this emergency rule is fair under the circumstances.   The Board of Medicine first raised the possibility of developing this rule at its April, 2019, board meeting.  At that time the Board of Medicine instructed legal counsel to draft proposed language and asked staff to have it placed on the agenda for the June, 2019, meeting of the Joint Board of Medicine and Board of Osteopathic Medicine Surgical Care/Quality Assurance Committee (Joint Committee).  The matter was noticed and placed on the agenda for the Joint Committee and the agenda was published approximately two weeks prior to the meeting.  Interested parties such as the Florida Medical Association and the Florida Society of Plastic Surgeons were well aware of the situation and its representatives even submitted draft proposed rules to the Board’s legal counsel in advance of the Joint Committee meeting.  
	“Brazilian Butt Lifts” have also been well covered by the media since as early as May, 2016.  Extensive coverage has been provided by local and national media of instances where patients suffered injuries, both fatal and non-fatal, when undergoing gluteal fat grafts.  It is safe to say that this issue has been on the public radar for some time as well of that of the medical profession.
	It is clear that persons and entities interested in this issue were well aware of the Board’s intention to address the standard of care for gluteal fat grafts at its June, 2019, meeting.  They were put on notice through formal board action and through the extensive media coverage of the issue.  The public was given ample opportunity to participate in the rulemaking process and did so at the properly noticed Joint Committee meeting.  Given such, it is clear that the procedure employed by the board to promulgate this emergency rule was fully transparent and fair under the circumstances.

SUMMARY:

The proposed emergency rule amendment clarifies the standard of care for gluteal fat grafting.

THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS:

Kama Monroe, J.D., Executive Director, Board of Osteopathic Medicine/MQA, 4052 Bald Cypress Way, Bin # C06, Tallahassee, Florida 32399-3256.

PRINT PUBLISH DATE:

6/28/2019 Vol. 45/126

OVERSIGHT COMMITTEE:

Joint Administrative Procedures Committee
Florida Administrative Law Central Online Network (F.A.L.C.O.N.)

RELATED COURT CASES:

Division of Administrative Hearings

FEDERAL eRULEMAKING
WEB PORTAL:

Regulations.gov

HOW TO LINK TO
THIS NOTICE:

http://flrules.org/gateway/ruleno.asp?id=64B15ER19-2&PDate=6/28/2019&Section=4

REFERENCE MATERIALS:

No reference(s).

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