In the Journals

Fewer women undergoing power morcellation since FDA warning

Fewer women are undergoing minimally invasive hysterectomy since the FDA first released a safety communication regarding power morcellation in April 2014, according to results of a retrospective cohort study conducted by researchers from University of Michigan.

However, because more women underwent traditional hysterectomies vaginally or abdominally, there has been a significant increase in hospital readmission and postoperative complications.

John A. Harris

John A. Harris

“We know that for a significant number of women, a minimally invasive procedure that avoids the risks of surgery is a viable option and often the safest,” John A. Harris, MD, MSc, a Robert Wood Johnson Foundation clinical scholar in the department of obstetrics and gynecology at University of Michigan and a member of the Institute for Healthcare Policy and Innovation, said in a press release. “Since the FDA communication, we saw a decrease in minimally invasive hysterectomies.

“We found that since the FDA communication, the risk of postoperative complications for women undergoing hysterectomies actually increased. We did not examine the underlying cause for these changes, but it is associated with the FDA communication on morcellation and cancer risk.”

During power morcellation, a tiny instrument grinds up uterine fibroids — or benign tumors within the uterus — and allows for their removal via a laparoscope. The minimally invasive procedure allows for a smaller incision, quicker recovery period, fewer side effects and lower rate of morbidity than more invasive open surgeries. Open surgeries include myomectomy — in which fibroids are removed but healthy tissue of the uterus is left intact — and hysterectomy, which involves the surgical removal of all or part of the uterus.

The FDA first issued a safety communication discouraging power morcellation use in women with uterine fibroids in April 2014. The agency then issued an “immediately in effect” guidance in November 2014 to warn against the use of morcellators in hysterectomies or myomectomies due to the potential that they can spread undetected uterine sarcomas.

After excluding women based on cancer indication, cervical dysplasia, endometrial hyperplasia and missing covariate data, the researchers analyzed data from 15,372 women who underwent a hysterectomy in Michigan from Jan. 1, 2013 through Dec. 31, 2014.

The investigators used April 17, 2014 — the date the first FDA communication was publicized — as the fulcrum for the analysis.

The use of laparoscopic hysterectomies in the 8 months following the FDA communication decreased 4.1% (P = .005) compared with the 15 months prior to the communication. Vaginal (2.4%; P = .012) and abdominal (1.7%) hysterectomies increased during the study period. 

At the same time, major complications associated with the open surgical procedures increased significantly from 2.2% before the FDA statement to 2.8% afterward (P = .015).

Likewise, the rate of readmission to a hospital with 30 days of surgery increased from 3.4% before the FDA communication to 4.2% after the communication (P = .025). The median risk-adjusted total episode cost for readmission was $5,847 (interquartile range, $5,478-$10,389).

“We found a 27% increase in major, non-blood transfusion, postoperative complications following the FDA safety communication as well as a 25% increase in hospital readmissions,” the researchers wrote. “These findings are concerning for several reasons.”

Those concerns that although the FDA safety communication regarding use of the procedure for removal of uterine fibroids, the researchers found laparoscopic hysterectomy use decreased for all benign indications. Research also has indicated that the prevalence of occult uterine sarcoma is low, around 0.07% to 0.49%.

Further, media portrayal and misperception of the FDA safety communication may have contributed a raised level of concern about any type of morcellation by patients and surgeons.

 “The rare event of worsened outcomes from an occult malignancy after morcellation must be balanced with advantages of decreased complications, length of stay, and improved satisfaction associated with minimally invasive hysterectomy,” Harris and colleagues wrote. – by Anthony SanFilippo

Disclosure: The researchers report no relevant financial disclosures.

Fewer women are undergoing minimally invasive hysterectomy since the FDA first released a safety communication regarding power morcellation in April 2014, according to results of a retrospective cohort study conducted by researchers from University of Michigan.

However, because more women underwent traditional hysterectomies vaginally or abdominally, there has been a significant increase in hospital readmission and postoperative complications.

John A. Harris

John A. Harris

“We know that for a significant number of women, a minimally invasive procedure that avoids the risks of surgery is a viable option and often the safest,” John A. Harris, MD, MSc, a Robert Wood Johnson Foundation clinical scholar in the department of obstetrics and gynecology at University of Michigan and a member of the Institute for Healthcare Policy and Innovation, said in a press release. “Since the FDA communication, we saw a decrease in minimally invasive hysterectomies.

“We found that since the FDA communication, the risk of postoperative complications for women undergoing hysterectomies actually increased. We did not examine the underlying cause for these changes, but it is associated with the FDA communication on morcellation and cancer risk.”

During power morcellation, a tiny instrument grinds up uterine fibroids — or benign tumors within the uterus — and allows for their removal via a laparoscope. The minimally invasive procedure allows for a smaller incision, quicker recovery period, fewer side effects and lower rate of morbidity than more invasive open surgeries. Open surgeries include myomectomy — in which fibroids are removed but healthy tissue of the uterus is left intact — and hysterectomy, which involves the surgical removal of all or part of the uterus.

The FDA first issued a safety communication discouraging power morcellation use in women with uterine fibroids in April 2014. The agency then issued an “immediately in effect” guidance in November 2014 to warn against the use of morcellators in hysterectomies or myomectomies due to the potential that they can spread undetected uterine sarcomas.

After excluding women based on cancer indication, cervical dysplasia, endometrial hyperplasia and missing covariate data, the researchers analyzed data from 15,372 women who underwent a hysterectomy in Michigan from Jan. 1, 2013 through Dec. 31, 2014.

The investigators used April 17, 2014 — the date the first FDA communication was publicized — as the fulcrum for the analysis.

The use of laparoscopic hysterectomies in the 8 months following the FDA communication decreased 4.1% (P = .005) compared with the 15 months prior to the communication. Vaginal (2.4%; P = .012) and abdominal (1.7%) hysterectomies increased during the study period. 

At the same time, major complications associated with the open surgical procedures increased significantly from 2.2% before the FDA statement to 2.8% afterward (P = .015).

Likewise, the rate of readmission to a hospital with 30 days of surgery increased from 3.4% before the FDA communication to 4.2% after the communication (P = .025). The median risk-adjusted total episode cost for readmission was $5,847 (interquartile range, $5,478-$10,389).

“We found a 27% increase in major, non-blood transfusion, postoperative complications following the FDA safety communication as well as a 25% increase in hospital readmissions,” the researchers wrote. “These findings are concerning for several reasons.”

Those concerns that although the FDA safety communication regarding use of the procedure for removal of uterine fibroids, the researchers found laparoscopic hysterectomy use decreased for all benign indications. Research also has indicated that the prevalence of occult uterine sarcoma is low, around 0.07% to 0.49%.

Further, media portrayal and misperception of the FDA safety communication may have contributed a raised level of concern about any type of morcellation by patients and surgeons.

 “The rare event of worsened outcomes from an occult malignancy after morcellation must be balanced with advantages of decreased complications, length of stay, and improved satisfaction associated with minimally invasive hysterectomy,” Harris and colleagues wrote. – by Anthony SanFilippo

Disclosure: The researchers report no relevant financial disclosures.