Preview Newsletter
Morcellation Media Monitoring 08/10/2015
-
Members of Congress Call on GAO to Investigate Surgical Tool
Aug 7, 2015 | Wall Street Journal
By Jennifer Levitz
Twelve members of Congress sent a letter to the U.S. Government Accountability Office Friday asking the agency to investigate a controversial gynecological device that can spread cancer in women. “Hundreds, if not thousands of women in America are dead because of a medical device known as the laparoscopic power morcellator,” said the letter, signed by a bipartisan group of lawmakers that included Rep. Mike Fitzpatrick (R., Pa.) and Rep. Louise Slaughter (D., N.Y.). -
GAO asked to investigate FDA over morcellator device
Aug 8, 2015 | The Philadelphia Inquirer
By Marie McCullough
Twelve members of Congress have asked the U.S. Government Accountability Office to investigate why an electric device used in gynecologic surgery was marketed for two decades before safety warnings were issued by the Food and Drug Administration. The tissue-dissecting device, called a power morcellator, enables hysterectomies to be done through small rather than large abdominal incisions, but it can also spread and worsen an undetected uterine cancer. -
Power morcellation: What you should know
Aug 6, 2015 | Healio
The FDA issued a warning in late 2014 about the use of power morcellators to treat uterine fibroids. Eight months later, the debate about the safety of power morcellation continues to rage in the gynecologic oncology community. Here is an overview of the procedure, a summary of the FDA’s guidance and a glimpse into its early impact.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
-
Members of Congress Call on GAO to Investigate Surgical Tool
Aug 7, 2015 | Wall Street Journal
By Jennifer Levitz
Twelve members of Congress sent a letter to the U.S. Government Accountability Office Friday asking the agency to investigate a controversial gynecological device that can spread cancer in women.
“Hundreds, if not thousands of women in America are dead because of a medical device known as the laparoscopic power morcellator,” said the letter, signed by a bipartisan group of lawmakers that included Rep. Mike Fitzpatrick (R., Pa.) and Rep. Louise Slaughter(D., N.Y.).
A GAO investigation would heighten scrutiny of the Food and Drug Administration’s approval and monitoring of the power morcellator, which had been used in tens of thousands of minimally invasive procedures a year. The device is used primarily in hysterectomies, to slice up common benign uterine masses known as fibroids so the bulky tissue could be removed through tiny incisions.
Last year, however, the FDA warned that women undergoing the procedure have an estimated 1 in 350 chance of harboring a hidden cancer that power morcellators can spread and worsen.
The FDA declined to comment.
The FDA called for a black-box warning—its strongest caution—on the device last November.Johnson & Johnson,which was the largest manufacturer of the device, withdrew its version from the market last July, and many hospitals have stopped or sharply curtailed use. Morcellators made by other companies remain on the market.
The FDA has cleared at least 10 power morcellators for sale since the first one entered the market 24 years ago. Though device applications and other records show the agency knew early on that morcellators could spread dangerous cells, the FDA said the magnitude of the risk wasn’t recognized until the issue came into the spotlight in late 2013.
Morcellators and nearly all other devices were authorized under a system that has long been criticized as too lenient, while the FDA has defended the process as a good balance between innovation and safety.
The letter sent to the GAO Friday said that the FDA’s warning about power morcellators “came decades after some studies were already pointing to a serious problem.”
Despite the studies, “the FDA, the medical device industry, and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-10,000,” according to the letter. “How did they get it wrong for so long?” the letter said.
The members of Congress asked the GAO to investigate whether the FDA’s approval process sufficiently identified risks of the device before it hit the market; whether manufacturers and the FDA appropriately monitored problems; how manufacturers trained doctors; and steps the FDA is now taking to determine whether the power morcellator is safe to stay on the market.
The GAO typically takes several weeks to review requests from Congress, said GAO spokesman Chuck Young. “We typically look at such things as whether data needed would be available, whether there are any legal obstacles, whether an inspector general’s office has work under way, as well as several other factors,” he said.
-
GAO asked to investigate FDA over morcellator device
Aug 8, 2015 | The Philadelphia Inquirer
By Marie McCullough
Twelve members of Congress have asked the U.S. Government Accountability Office to investigate why an electric device used in gynecologic surgery was marketed for two decades before safety warnings were issued by the Food and Drug Administration.
The tissue-dissecting device, called a power morcellator, enables hysterectomies to be done through small rather than large abdominal incisions, but it can also spread and worsen an undetected uterine cancer.
After that horrible scenario befell anesthesiologist Amy Reed at a Boston hospital in late 2013, she and her husband, heart surgeon Hooman Noorchashm, launched a campaign to ban electric morcellators. The couple and their six children have since moved to the Philadelphia area, where she has recently been treated for a second recurrence of uterine leiomyosarcoma.
Their campaign prompted an FDA review that led hospitals and insurers to sharply curtail use of the device. The FDA concluded that up to one in 350 women undergoing hysterectomy with power morcellation might have a hidden cancer - not one in 10,000, the risk that gynecologists cited after the power morcellator first came on the market in 1993.
"How did they get it so wrong for so long?" asks the Aug. 7 letter to the GAO, which investigates how the government spends tax dollars. "We respectfully request that you investigate the root cause failure that ultimately led to the FDA's black box warning on ... morcellators in November 2014."
The lead signer is Rep. Mike Fitzpatrick (R., Pa.), who has joined Reed and Noorchashm in pushing for broad changes in the medical-device approval process. The other signers include high-ranking House members Louise Slaughter (D., N.Y.) and Rosa L. DeLauro (D., Conn.).
Noorchashm, who now works for Thomas Jefferson University Hospital, praised Fitzpatrick's leadership Friday.
GAO spokesman Chuck Young said the agency would decide whether to investigate after considering factors including the availability of data, potential legal obstacles, and investigations that may be underway.
Read more at http://www.philly.com/philly/health/20150808_GAO_asked_to_investigate_FDA_over_morcellator_device.html#bSWW6RcYVW6wsD5e.99 -
Power morcellation: What you should know
Aug 6, 2015 | Healio
The FDA issued a warning in late 2014 about the use of power morcellators to treat uterine fibroids.
Eight months later, the debate about the safety of power morcellation continues to rage in the gynecologic oncology community.
Here is an overview of the procedure, a summary of the FDA’s guidance and a glimpse into its early impact.
Question: What is power morcellation?
Answer: During power morcellation, a tiny instrument with a rapidly rotating blade grinds up uterine fibroids — or benign tumors within the uterus — and allows for their removal via a laparoscope.
Q: Why is the procedure performed?
A: It 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.
Q: Why did the FDA issue its warning?
A: The agency’s “immediately in effect” guidance — issued in November 2014 — warns against the use of morcellators in hysterectomies or myomectomies in the majority of women due to the potential that they can spread undetected uterine sarcomas.
Q: What are the FDA’s specific recommendations?
A: The FDA recommended manufacturers of laparoscopic power morcellators include a boxed warning to acknowledge the risk that undetected leiomyosarcomas or other malignancies within uterine tissue can be disseminated throughout a woman’s pelvic and abdominal cavities during morcellation, increasing risks for morbidity and mortality.
The guidance also recommends two contraindications be included on product labeling.
One recommendation is to contraindicate laparoscopic power morcellators for women who are peri- or postmenopausal, as well as those who are candidates for en bloc tissue removal through the vagina or mini-laparotomy incision. Most of the estimated 50,000 to 100,000 women who undergo laparoscopic procedures for hysterectomy each year in the United States meet these criteria.
The guidance also recommends contraindication of the devices during gynecologic surgery in which the tissue to be morcellated is either suspected or known to be cancerous.
Q: How big is the risk that power morcellators will spread undetected malignancies?
A: Based on quantitative analysis of available data, the FDA estimated that approximately 1 in 352 women who undergo hysterectomy or myomectomy for presumed benign fibroids has an unsuspected uterine cancer, and that 1 in 498 has an unsuspected leiomyosarcoma. However, the Society of Gynecologic Oncology issued a statement suggesting the FDA based its recommendation on studies included in a retrospective case series with “low-quality evidence.”
“The FDA would not approve a device using such low-quality retrospective data,” the statement read. “It is concerning that the FDA would now consider banning a device with a similar low level of evidence.”
Q: What has other research shown?
A: A team of researchers led by Jason D. Wright, MD, division chief of gynecologic oncology at Columbia University Medical Center, conducted a study that evaluated more than 36,000 women who underwent minimally invasive hysterectomy between 2006 and 2012. Their findings, published in JAMA, showed the risk of occult malignancy was 1 in 368.
However, a meta-analysis performed by Elizabeth A. Pritts, MD, an obstetrician–gynecologist at and medical director of Wisconsin Fertility Clinic in Middleton, Wisc., and colleagues suggested the risks are not as high as the FDA indicated.
The analysis by Pritts and colleagues included 133 studies with evaluable data. Their findings indicated an occult leiomyosarcoma would be found in 0.12 of every 1,000 surgeries, whereas the FDA statistics indicate an occult leiomyosarcoma would be found in 2.01 of every 1,000 surgeries.
A subsequent study by Wright and colleagues, published in JAMA Oncology, assessed pathologic outcomes among patients who underwent myomectomy with electric power morcellation. They found that the prevalence of cancer and pre-cancer abnormalities was 1 in 1,073 women, indicating the risk for cancer is “much lower” among women who undergo myomectomy than hysterectomy, Wright and colleagues wrote.
Q: How does age contribute to patients’ risk?
A: In the myomectomy study conducted by Wright and colleagues, older age was the strongest risk factor for cancer.
In another study published in The Oncologist, Andrew S. Brohl, MD, of the department of hematology and medical oncology at Icahn School of Medicine at Mount Sinai, and colleagues sought to determine the incidence of unexpected uterine sarcoma in women who underwent surgery for suspected benign leiomyoma. They determined the risk for unexpected uterine sarcoma increased with age. Women aged younger than 30 years demonstrated the lowest risk (<1 in 500), whereas women aged 75 to 79 years demonstrated the highest risk (1 in 98).
Q: What has changed since the FDA issued its guidance about power morcellation?
A: Soon after the FDA’s announcement, Johnson & Johnson, a leading manufacturer of laparoscopic power morcellators, pulled its products off the market. Several large institutions — including Brigham and Women’s Hospital and Cleveland Clinic — stopped performing laparoscopic power morcellation. Multiple insurance companies also have stopped covering routine use of power morcellators.
The debate also has prompted conversations about whether steps can be taken to make the procedure safer, ensuring it remains accessible to patients who understand their potential risks and provide informed consent. These efforts could include pre-operative imaging or biopsy, as well as the use of containment bags, which allow fibroids to be morcellated inside a bag in the abdominal region to prevent the potential spread of tissue.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
Add recipients
Suggested