Amy Reed, MD, PhD, an anesthesiologist died because of uterine leiomyosarcoma on Wednesday, May 24 at age of 44.
She underwent a laproscopic hysterectomy in October 2013 for fibroid, but her undiagnosed, occult uterine leiomyosarcoma was upstaged because of dispersion in abdominal cavity by the use of power morcellator. Since then, the power morcellator is the focal
point of a four-year debate that has divided the surgical field.
The surgery took place at the Harvard-affiliated Brigham and Women’s Hospital in Boston where both Reed and her husband Noorchashm worked.
She came to know about the diagnosis
only after the histopathology reports came in after the surgery. To date,
there isn’t a reliable method to determine whether or not a uterine tumor is
malignant before it has been removed and fully examined. The
estimated incidence of leiomyosarcoma is 0.64 per 100,000 women.
The couple
immediately knew they were in trouble and it was just a race against time.
She turned her calamity into advocacy against
the use of power morcellator and have fought an uphill battle to ban morcellation.
Introduced to the United States in
1993 and approved by the FDA in 1995, the device gained rapid popularity among gynecologists
particularly for the removal of fibroids and in hysterectomies.
It is estimated that Power Morcellator
is used in about 600,000 minimally invasive hysterectomies and myomectomies
annually.
Traditional cancer therapies were all
ineffective as the morcellation has already advanced the cancer to stage IV. She fought an epic battle against the deadly
disease along with a campaign to ban morcellation. She and her husband wrote numerous
emails to FDA, along with device makers and hospitals and legislators. They
also waged the war on social media and other traditional medias.
It is because of her
efforts that FDA revisited the literature and made an announcement on April 17,
2014 “Importantly, based on an FDA analysis of currently available data, it is
estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the
treatment of fibroids is found to have an unsuspected uterine sarcoma, a type
of uterine cancer that includes leiomyosarcoma.”
“If laparoscopic power
morcellation is performed in women with unsuspected uterine sarcoma, there is a
risk that the procedure will spread the cancerous tissue within the abdomen and
pelvis, significantly worsening the patient’s likelihood of long-term survival.”
“For this reason, and
because there is no reliable method for predicting whether a woman with
fibroids may have a uterine sarcoma, the FDA discourages the use of
laparoscopic power morcellation during hysterectomy or myomectomy for uterine
fibroids.”
Soon, after this FDA
newsletter, Johnson & Johnson pulled its device off the market.
Morcellator use dropped
after this, but was not completely banned. By September 2016, the FDA received
285 additional reports of cancer spread by morcellation.
Many gynecologist
surgeons however, continue to use the morcellator. In 2014, ACOG issued a position
statement on Power Morcellation quoting that while it supports FDA commitment
to women’s health, but believe that power morcellation has a role in
gynecologic surgery. A careful selection of cases and evaluation of woman’s
risk for leiomyosarcoma plus informed consent can protect women against the
negative outcome.
Following the ongoing controversy,
on April 7, 2016, FDA granted permission to an Irish company to market the
“PneumoLiner,” a first-of-its-kind containment system indicated for isolating
and containing uterine tissue during a minimally invasive hysterectomy or
myomectomy.
However, FDA requires
the manufacturer to warn patients and health care providers that the
containment system has not been proven to reduce the risk of spreading cancer
during power morcellation.
FDA recommendation can
be accessed here.
ACOG full statement can
be accessed here.
Drs. Noorchashm and Reed
make a joint presentation at a symposium focused on FDA law and law enforcement
at Widener University Law School.
