Clinical trial stirs controversy over power morcellator bags

A clinical trial scheduled to evaluate the safety and efficacy of a bag designed to catch cancerous tissue from power morcellation in women undergoing laparoscopic hysterectomies has rekindled debate in the gynecologic community over the controversial procedure.

The study, which will be conducted at University of North Carolina and led by researcher Erin Carey, MD, MSCR, division director of UNC minimally invasive gynecologic surgery, plans to examine the use of the Olympus PK morcellator and its revamped PneumoLiner bag in 140 pre- and perimenopausal women aged 35 to 50 years. Olympus America — manufacturer of both devices — is sponsoring the 2-year clinical trial.

Morcellation of fibroid tissue has been under scrutiny since the discovery that the spinning blades from power morcellators can spread cancerous tissue within the abdominal cavity, significantly worsening a patient’s survival. In 2014, the FDA warned against the use of laparoscopic power morcellators “in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”

Following the FDA recommendation, the number of minimally invasive hysterectomies that used power morcellation declined from 13.7% (95% CI, 13.2-14.2) in the fourth quarter of 2013 to 2.8% (95% CI, 2.4-3.1) in the first quarter of 2015 (P < .001), according to a study by Jason D. Wright, MD, chief of the division of gynecologic oncology and associate professor of obstetrics and gynecology at Columbia University Medical Center, and colleagues.

“The controversy surrounding the morcellator is that you’re essentially taking tissue and mincing it into smaller pieces in the abdominal cavity. If there is cancer [in the fibroid tissue], there is the potential that you can spread those cancer cells throughout the abdominal cavity,” Wright told HemOnc Today. “With morcellation occurring in a bag, theoretically, these cancerous fragments of tissue would not be able to spread.”

The FDA estimates that approximately one in 352 women who undergo hysterectomy or myomectomy to remove presumed benign fibroids learns she has uterine cancer, and that one in 498 women has an unsuspected leiomyosarcoma.

The FDA approved the PneuomoLiner bag in April 2016, noting that heath care providers must share with patients the potential risks of the device. The bag also must include a warning label stating it has not been clinically demonstrated to reduce the risk for spreading cancer.

Hooman Noorchashm, MD, PhD, a cardiac surgeon whose wife, Amy Reed, died of uterine leiomyosarcoma at the age of 44 — 4 years after her cancer spread following power morcellation — questioned via a post on Medium.com the ethical value of the UNC clinical trial and its associated risks to participants.

The trial has an anticipated start date in September 2017. However, a spokesperson from UNC-Chapel Hill noted the institution is reviewing concerns raised by Noorchashm.

“The University is committed to protecting the rights, safety and welfare of research participants,” Joanne Peters Denny, a UNC-Chapel Hill spokeswoman, told HemOnc Today. “Consistent with this commitment, we take seriously any questions or concerns arising from third parties about our research studies.

“Our Institutional Review Boards are charged with reviewing, approving and overseeing all research studies involving human participants to ensure risks are properly identified and disclosed to research participants,” Peters Danny continued. “Our [review board] is currently reviewing the matters Dr. Noorchashm raised. At the conclusion of this review, we will provide further information.”

Representatives from Olympus America had not returned phone and email messages seeking comment at the time of reporting.

The primary endpoint of the study is to determine the durability of the PneumoLiner bag. Failure is defined as “disruption of the isolation bag or visible tissue dissemination.” The device will be declared safe if no more than one bag failure is observed in 140 procedures.

Secondary endpoints include ease of use of the PK Morcellator in conjunction with the PneumoLiner bag, intra- or postoperative complications, mean procedure time, estimated blood loss, postoperative pain, hospitalization length and specimen weight.

Wright said he would not deter women from participating in a trial such as this, saying most women would prefer a minimally invasive surgery that requires 2 to 4 weeks of recovery than an open procedure that requires a longer hospital stay and a recovery period of 6 weeks.

“This is the type of data we need,” he said. “We know minimally invasive surgery offers a lot of benefits and we want to be able to offer it to as many women as possible. These types of devices and innovation need to be tested. Theoretically, this should be a safe procedure, morcellating in a bag and trying to limit interabdominal dissemination. But, until this is thoroughly investigated, we won’t know the safety of this.”

It is possible that occult microscopic tumor cells can still escape the bag, Wright added.

“We don’t really know the true incidence of rupture of the bag and spillage of the contents,” he said. “One of the problems with morcellators is that they’ve been diffused in practice without solid scientific evidence, and this is the exact type of study we need to be doing to get this evidence before these devises are used widely in practice.”

Because the incidence of occult cancer is higher in postmenopausal women undergoing hysterectomies, if the PK morcellator and PneuemoLiner bag are found effective, more oncologists may recommend the procedure for premenopausal women requiring laparoscopic hysterectomies, Wright said.

“In postmenopausal women, in particular, the risks of the procedure may outweigh the benefits,” he said. “In younger women, the risk for cancer is still quite low and in these women, the benefits of being able to have a minimally invasive surgical procedure may outweigh the small risks associated with morcellation. If the bag is found to be a safe technology and there is published data on this, I would think it would start to diffuse into practice again.” – by Chuck Gormley

References:

FDA. Immediately in effect guidance document: Product labeling for laparoscopic power morcellators. 2014. Available at www.fda.gov/downloads/MedicalDevices DeviceRegulationandGuidance GuidanceDocuments/UCM424123.pdf. Accessed on Aug. 16, 2017.

FDA. Laparoscopic power morcellation during uterine surgery for fibroids. 2014. Available at: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM404148.pdf. Accessed on Aug. 16, 2017.

Wright JD, et al. JAMA. 2016;doi:10.1001/jama.2016.9432.

For more information:

Jason D. Wright, MD, can be reached at jw2459@columbia.edu.

Disclosure: Wright reports he has no relevant financial disclosures.

A clinical trial scheduled to evaluate the safety and efficacy of a bag designed to catch cancerous tissue from power morcellation in women undergoing laparoscopic hysterectomies has rekindled debate in the gynecologic community over the controversial procedure.

The study, which will be conducted at University of North Carolina and led by researcher Erin Carey, MD, MSCR, division director of UNC minimally invasive gynecologic surgery, plans to examine the use of the Olympus PK morcellator and its revamped PneumoLiner bag in 140 pre- and perimenopausal women aged 35 to 50 years. Olympus America — manufacturer of both devices — is sponsoring the 2-year clinical trial.

Morcellation of fibroid tissue has been under scrutiny since the discovery that the spinning blades from power morcellators can spread cancerous tissue within the abdominal cavity, significantly worsening a patient’s survival. In 2014, the FDA warned against the use of laparoscopic power morcellators “in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”

Following the FDA recommendation, the number of minimally invasive hysterectomies that used power morcellation declined from 13.7% (95% CI, 13.2-14.2) in the fourth quarter of 2013 to 2.8% (95% CI, 2.4-3.1) in the first quarter of 2015 (P < .001), according to a study by Jason D. Wright, MD, chief of the division of gynecologic oncology and associate professor of obstetrics and gynecology at Columbia University Medical Center, and colleagues.

“The controversy surrounding the morcellator is that you’re essentially taking tissue and mincing it into smaller pieces in the abdominal cavity. If there is cancer [in the fibroid tissue], there is the potential that you can spread those cancer cells throughout the abdominal cavity,” Wright told HemOnc Today. “With morcellation occurring in a bag, theoretically, these cancerous fragments of tissue would not be able to spread.”

The FDA estimates that approximately one in 352 women who undergo hysterectomy or myomectomy to remove presumed benign fibroids learns she has uterine cancer, and that one in 498 women has an unsuspected leiomyosarcoma.

The FDA approved the PneuomoLiner bag in April 2016, noting that heath care providers must share with patients the potential risks of the device. The bag also must include a warning label stating it has not been clinically demonstrated to reduce the risk for spreading cancer.

Hooman Noorchashm, MD, PhD, a cardiac surgeon whose wife, Amy Reed, died of uterine leiomyosarcoma at the age of 44 — 4 years after her cancer spread following power morcellation — questioned via a post on Medium.com the ethical value of the UNC clinical trial and its associated risks to participants.

PAGE BREAK

The trial has an anticipated start date in September 2017. However, a spokesperson from UNC-Chapel Hill noted the institution is reviewing concerns raised by Noorchashm.

“The University is committed to protecting the rights, safety and welfare of research participants,” Joanne Peters Denny, a UNC-Chapel Hill spokeswoman, told HemOnc Today. “Consistent with this commitment, we take seriously any questions or concerns arising from third parties about our research studies.

“Our Institutional Review Boards are charged with reviewing, approving and overseeing all research studies involving human participants to ensure risks are properly identified and disclosed to research participants,” Peters Danny continued. “Our [review board] is currently reviewing the matters Dr. Noorchashm raised. At the conclusion of this review, we will provide further information.”

Representatives from Olympus America had not returned phone and email messages seeking comment at the time of reporting.

The primary endpoint of the study is to determine the durability of the PneumoLiner bag. Failure is defined as “disruption of the isolation bag or visible tissue dissemination.” The device will be declared safe if no more than one bag failure is observed in 140 procedures.

Secondary endpoints include ease of use of the PK Morcellator in conjunction with the PneumoLiner bag, intra- or postoperative complications, mean procedure time, estimated blood loss, postoperative pain, hospitalization length and specimen weight.

Wright said he would not deter women from participating in a trial such as this, saying most women would prefer a minimally invasive surgery that requires 2 to 4 weeks of recovery than an open procedure that requires a longer hospital stay and a recovery period of 6 weeks.

“This is the type of data we need,” he said. “We know minimally invasive surgery offers a lot of benefits and we want to be able to offer it to as many women as possible. These types of devices and innovation need to be tested. Theoretically, this should be a safe procedure, morcellating in a bag and trying to limit interabdominal dissemination. But, until this is thoroughly investigated, we won’t know the safety of this.”

It is possible that occult microscopic tumor cells can still escape the bag, Wright added.

“We don’t really know the true incidence of rupture of the bag and spillage of the contents,” he said. “One of the problems with morcellators is that they’ve been diffused in practice without solid scientific evidence, and this is the exact type of study we need to be doing to get this evidence before these devises are used widely in practice.”

PAGE BREAK

Because the incidence of occult cancer is higher in postmenopausal women undergoing hysterectomies, if the PK morcellator and PneuemoLiner bag are found effective, more oncologists may recommend the procedure for premenopausal women requiring laparoscopic hysterectomies, Wright said.

“In postmenopausal women, in particular, the risks of the procedure may outweigh the benefits,” he said. “In younger women, the risk for cancer is still quite low and in these women, the benefits of being able to have a minimally invasive surgical procedure may outweigh the small risks associated with morcellation. If the bag is found to be a safe technology and there is published data on this, I would think it would start to diffuse into practice again.” – by Chuck Gormley

References:

FDA. Immediately in effect guidance document: Product labeling for laparoscopic power morcellators. 2014. Available at www.fda.gov/downloads/MedicalDevices DeviceRegulationandGuidance GuidanceDocuments/UCM424123.pdf. Accessed on Aug. 16, 2017.

FDA. Laparoscopic power morcellation during uterine surgery for fibroids. 2014. Available at: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM404148.pdf. Accessed on Aug. 16, 2017.

Wright JD, et al. JAMA. 2016;doi:10.1001/jama.2016.9432.

For more information:

Jason D. Wright, MD, can be reached at jw2459@columbia.edu.

Disclosure: Wright reports he has no relevant financial disclosures.