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In an official email to the Marchand Institute for Minimally Invasive Surgery, a major research institute in the field of minimally invasive gynecologic surgery and tissue morcellation, the FDA clarified it’s position on the “Black Box” warning currently placed on laparoscopic surgical power morcellation devices (LPM’s) in the United States.
Because LPM’s have the potential to worsen the prognosis of women who suffer from a type of cancer of the uterus, “leiomyosarcoma,” there has been much debate as to whether they should ever be permissible in gynecologic surgery, as leiomyosarcoma can never be completely ruled out. This has been an extremely controversial topic in the field of Minimally Invasive Gynecologic Surgery (MIGS), because the use of these power devices allows surgeons to remove extremely large masses from the abdomen using very small holes. This results in a very speedy recovery with minimal risk of complications for patients. In some cases this can create a circumstance where a woman who otherwise may not be healthy enough to have a surgery that required a large incision, maybe be healthy enough to have a morcellation surgery through tiny holes.
In 2007, Dr. Greg Marchand and the late Dr. Richard Demir performed such a surgery on a woman with a seven pound uterus who suffered from severe morbid obesity as well as type II diabetes and heart failure. They were able to remove her uterus using an LPM in an 8 hour surgery that set a Guinness World Record for the largest uterus ever removed without resorting to laparotomy (cutting the patient open.)
Dr. Marchand and Dr. Demir contend that in cases such as this, where a woman is not well enough to survive a large incision open surgery, it is imperative that LPM devices be available to give these woman a chance at survival. Unfortunately, following the FDA “Black Box” warning issued to all LPM devices in 2020, most hospitals in the USA no longer carry LPMs, essentially eliminating their use in gynecologic surgery today.
In their response to the Marchand Institute for Minimally Invasive Surgery and Dr. Greg Marchand, the FDA’s “DICE” Division (Division of Industry and Consumer Education) stated that:
“The May 2023 guidance entitled “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures” does not address the “black box” warning on laparoscopic power morcellators. The new guidance is limited to tissue containment systems, therefore the “black box” warning is still in place.
The December 2020 guidance entitled “Product Labeling for Laparoscopic Power Morcellators” includes the black box warning and has not been revised to date.”
This is somewhat surprising news, as the FDA’s May 2023 Guidance contained much softer language than the December 2020 guidance, and seemed to not only condone the use of Tissue Containment Systems and LPM’s, but also to suggest that they have an important place in gynecologic surgery.
Quotes from Dr. Marchand:
“Wishing to ban surgical morcellation is exactly the same as wishing to ban all chemotherapy. Both are excellent life saving tools with a very narrow indication. Outside that indication they are both equally deadly.”
“Keep making the incisions smaller and fewer – the postoperative pain, recovery, and complications will follow.”
“I know what it’s like to face a diagnosis of cancer, and in my opinion, advancements in the surgical treatment of cancer are just as important as the newest cancer-fighting drugs and chemotherapy agents.”
Top OB Greg J. Marchand is available for comment and discussion panels!
Dr. Marchand has been on all major outlets, including the Today Show, Fox and Friends, and Inside edition, and is available for immediate booking in the LAX or PHX areas or by Skype and Zoom. (Links below.) Dr. Marchand is not opposed to heated panels, but prefers not to be involved in formats where talking over the other debate contestants is required.
Today Show: https://www.youtube.com/watch?v=8OVEVJQF4Vk
Inside Edition: https://www.facebook.com/watch/?v=1223329764502781
Fox and Friends: https://www.youtube.com/watch?v=yBk3UM5jz8Q
Newsmax: https://www.youtube.com/watch?v=3YQyCJ-vgW0
About the Marchand Institute for Minimally Invasive Surgery:
The Marchand Institute for Minimally Invasive Surgery is a research and educational not-for-profit corporation and functional “Think-Tank” for the advancement of women’s health and minimally invasive gynecologic surgery. The institute is located in Mesa, Arizona. The institute adheres to the highest levels of quality for their research and maintains an extremely diverse environment in the workplace. “Our efforts are split between the publication of high-quality medical research in women’s health and expert level surgical education.”
Institute Website: www.MarchandInstitute.org
About Dr. Greg Marchand MD:
Greg Marchand is the director of the Marchand Institute for Minimally Invasive Surgery, as well as the fellowship program director for the Institute’s SLS (Society of Laparoendoscopic Surgeons) Accredited fellowship in Minimally Invasive Gynecologic Surgery. Dr. Marchand is an associate professor of medicine at several local medical schools in Arizona, and enjoys teaching students, fellows and residents. Dr. Marchand holds dual certifications from the American Board of Obstetrics and Gynecology in both OBGYN and Minimally Invasive Gynecologic Surgery. Dr. Marchand is also accredited as a “Master Surgeon in Minimally Invasive Gynecologic Surgery” by the Surgical Review Corporation. Dr. Marchand is extensively published and has completed a two year fellowship in Minimally Invasive Gynecologic Surgery (MIGS). Dr. Marchand is recognized internationally as a pioneer in developing laparoscopic techniques, as well as an expert minimally invasive surgeon and teaching surgeon. Dr. Marchand was recently honored with a World Record for performing a total laparoscopic hysterectomy through the smallest incision ever. Dr. Marchand was also one half of the team that was recognized by the Guinness Book of World Records(TM) for removing the largest uterus ever without needing to cut open the patient. When he is not in the operating room Dr. Marchand enjoys low carb living and chasing around his 10 year old football star son, Sebastian. Dr. Marchand’s Website: www.GregMarchandMD.com
Publicist for Greg Marchand and the Marchand Institute for Minimally Invasive Surgery:
Wendy Guarisco
Guarisco Group
P: 404.354.6468
@wendygpr
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