06:18am Friday 17 November 2017

FDA Warning Leads to Rise in More Invasive Fibroid Surgeries

By Elizabeth Fernandez

A Food and Drug Administration warning against a tool used to break up fibroid tissue during laparoscopic surgeries has led to a shift toward more invasive surgeries for hysterectomies for women with uterine fibroids, according to a new study by researchers at UCSF Health. The authors say this shift could have a detrimental effect for women with uterine fibroids, a common, non-cancerous condition that develops in up to 70 percent of women prior to menopause.

The study is published in the November issue of Obstetrics & Gynecology.

“When a woman with fibroids elects to undergo surgery, we want to use the most minimally invasive approach possible, because she will have a much faster recovery,” said UCSF Health gynecologist Vanessa L. Jacoby, MD, MAS, the senior author of the paper. An associate professor of obstetrics and gynecology at UC San Francisco, Jacoby’s research has focused on minimally invasive treatments for women with uterine fibroids. She is the principal investigator for the University of California Fibroid Network, a statewide research collaboration to improve the care of women with fibroids.

“A laparoscopic approach to surgery is less invasive than open surgery called laparotomy,” Jacoby said. “But our study found that the FDA safety communication was associated with a decline in the use of laparoscopy, particularly in the inpatient setting.”

Uterine fibroids are the most common reason to undergo hysterectomy. The last 15 years have seen a rise in the use of minimally invasive laparoscopy to perform hysterectomy, enabled by the use of power morcellators, which break uterine fibroids into small pieces to be removed via tiny laparoscopic incisions.

But in late 2013, there was a spate of publicity around the case of a 40-year-old physician, Amy Reed, who underwent laparoscopic hysterectomy with the use of a power morcellator, and was diagnosed after surgery with a rare cancer, leading eventually to her untimely death. This led to rising concern about the safety of power morcellation for fibroid surgery. In April 2014, the FDA issued a safety communication discouraging the use of power morcellators, warning that the device could potentially spread undetected cancerous tissue.

“We believe that the FDA communication abruptly halted use of power morcellators, which prevented some gynecologists from using laparoscopy and shifted the hysterectomy approach toward more invasive surgeries instead,” Jacoby said.

In the new cross-sectional study, the researchers evaluated surgical changes before and after the FDA warning. They compared the proportion of hysterectomies for women with fibroids performed laparoscopically or by laparotomy in the 15 months before the FDA warning to a nine-month period afterward – the study timeframe was January 2013 to December 2014. They also evaluated whether fewer women with fibroids underwent myomectomy – removal of just the fibroids – versus hysterectomy after the FDA warning.

Altogether, 81,968 cases of women 18 or over were analyzed, including both inpatient and ambulatory patients from hospital databases in four U.S. states. The mean age for women undergoing inpatient hysterectomy or myomectomy was 45.5 years. The researchers said the sample was racially and ethnically diverse.

The researchers found that a clear increase in more invasive surgical approaches followed the FDA warning, with more women undergoing open hysterectomy compared with laparoscopy. This form of surgery has been associated with a higher risk of postoperative infection, as well as significantly longer hospital stays and overall recovery time, compared with the less invasive route of laparoscopy, the authors reported.

In the in-patient setting, the use of laparoscopy declined from 24.1 percent of all hysterectomies for women with fibroids before the FDA warning to 17.1 percent after it, with a corresponding increase in the more invasive, abdominal approach.

“In the last 15 years, we had been seeing a steady rise in the use of the less invasive laparoscopic approach for hysterectomy, so it’s even more significant to see the decline in numbers after the FDA communication,” said Jacoby.

The authors note that while they chose a large, geographically diverse study population, the four states selected for data extraction – New Jersey, Kentucky, Florida and Arizona – may not fully represent surgical trends throughout the entire country. They also say that more study is needed to evaluate continuing trends in fibroid surgery and whether changes in surgical approaches are having an overall detrimental health effect on women.

The other co-authors are Nina M. Clark, BS, and Michael Schembri, BS, a UCSF statistical programmer.  Jacoby and Schembri disclosed that they have received funding from Halt Medical supporting a study of women with uterine fibroids who were treated with radiofrequency ablation.

The research was supported by the UCSF PROF-PATH program through R25MD006832 from the National Institute on Minority Health and Health Disparities.

UC San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy; a graduate division with nationally renowned programs in basic, biomedical, translational and population sciences; and a preeminent biomedical research enterprise. It also includes UCSF Health, which comprises three top-ranked hospitals, UCSF Medical Center and UCSF Benioff Children’s Hospitals in San Francisco and Oakland, and other partner and affiliated hospitals and healthcare providers throughout the Bay Area.

 

 


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