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Morcellation Media Monitoring 01/25/2016
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Study finds minority, poor women not getting safer minimally invasive hysterectomies
Jan 23, 2016 | Baltimore Sun
By Andrea K. McDaniels
When Bonita "Bonnie" Hudak had a hysterectomy three years ago after being diagnosed with endometrial cancer, she recovered faster and suffered less pain than when she delivered a child by cesarean section many years before. -
Discovery in Morcellator Lawsuits Expedited Due to Plaintiffs’ Dire Health
Jan 22, 2016 | Injury Lawyer News
By Whitney Taylor
The health of many of the women who have filed claims against the manufacturers of power morcellators has deteriorated, prompting expedition of their legal proceedings.
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Morcellation
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Study finds minority, poor women not getting safer minimally invasive hysterectomies
Jan 23, 2016 | Baltimore Sun
By Andrea K. McDaniels
When Bonita "Bonnie" Hudak had a hysterectomy three years ago after being diagnosed with endometrial cancer, she recovered faster and suffered less pain than when she delivered a child by cesarean section many years before.
The C-section required a large cut that took weeks to heal and left an unattractive scar. For the hysterectomy, Hudak's doctor performed a robotic surgery that required only small incisions.
"I was pretty much flat on my back for about a week and then shortly after that I was able to walk around," said Hudak about her minimally invasive surgery. "And I was only taking Tylenol or ibuprofen for pain."
The 65-year-old, who lives in Columbia, is one of a growing number of women undergoing minimally invasive surgery to treat early stages of uterine cancer, but new research by Johns Hopkins Medicine found that there are large racial and economic disparities among those getting these procedures.
This disparity could result in negative health consequences for poor and minority communities because invasive open surgeries can result in more complications, such as infections that could mean longer hospital stays, readmissions and time away from work.
Years of research has found that less-invasive methods result in fewer complications than those that require large open incisions. The Society of Gynecologic Oncology and the American College of Surgeon's Commission on Cancer recently deemed minimally invasive surgeries the standard of care for treatment of uterine cancers that have not yet started to spread to other parts of the body.
Yet some groups are less likely to get the treatments. African-American and Hispanic patients, those insured by Medicaid, and those treated at hospitals with few endometrial cancer cases were less likely to undergo minimally invasive procedures. Doctors might not offer such procedures in communities where these patients live or patients might not know to ask for them.
"We found really dramatic disparities," said Dr. Amanda Fader, the study's lead author and director of the Johns Hopkins Kelly Gynecologic Oncology Service. "This corresponds with other disparities we see in cancer care for minorities, those in rural areas and others who are disadvantaged."
The study, which appeared in the January issue of Obstetrics and Gynecology, looked at data in the National Inpatient Sample database, which compiles information on patients from more than 1,000 hospitals in 45 states. Specifically, researchers analyzed the records of 32,560 patients who underwent robotic-assisted surgery, open hysterectomy or a laparoscopic procedure, in which thin medical instruments and a camera are inserted through small incisions to conduct surgery. All the patients had non-metastatic uterine cancer between 2007 and 2011, the time period analyzed.
The good news was that the use of minimally invasive procedures jumped during the time period, Fader said. About 50.8 percent of patients got the procedures in 2011, compared to 22 percent in 2007.
The bad news: Black and Hispanic women were less likely to get the surgeries. Patients on Medicaid, or those who had no insurance at all, also often did not get the surgeries.
Doctors who specialize in gynecologic cancers said that a large part of the problem is that not all physicians are trained in the minimally invasive methods. If doctors don't perform a large number of hysterectomies, they may not deem it necessary to get the training. The Hopkins study found that the procedures were performed just 23.6 percent of the time at "low volume" hospitals, or those where fewer than 10 hysterectomies in uterine cancer cases were performed a year.
"Despite the fact that technology and training does exist, medicine and surgery is a very rigid profession," said Vadim Morozov, an assistant professor of obstetrics, gynecology and reproductive sciences at the University of Maryland School of Medicine and a gynecologist at University of Maryland Medical Center. "We've always been innovative, but we've always been very slow to adapt" to it.
Morozov said patients may not know about the less-invasive methods and as a result don't ask for them.
Doctors also may prefer to perform the type of surgery they know best, he said.
"Doctors may not be comfortable offering it," Morozov said. "They offer patients what they are trained to do the best."
Dr. Teresa Diaz-Montes, a gynecologic oncologist at Mercy Medical Center, said there is a learning curve to become proficient in less-invasive hysterectomies.
"At the beginning of the learning curve, minimally invasive surgeries could take more operative time to be performed," she said.
Fader said that doctors may be wary of doing the more-invasive surgeries on obese patients — and uterine cancer is the most obesity-driven of cancers. She argued these women would benefit the most from less-invasive surgeries because they often have diabetes, high blood pressure, sleep apnea and other health problems that could lead to complications during surgery.
Anesthesia can put a strain on the heart and lungs, which can be dangerous for overweight people, doctors said. And fat around the internal organs can make it difficult to see in open surgeries.
Cost also may deter some from performing minimally invasive surgeries. The Hopkins study found that robotic hysterectomies can cost $2,000 more than open or laparoscopic surgeries. But open hysterectomies have more complications, which can add $7,000 to $8,000 more to the cost of each type of surgery, the study found.
There has been some controversy about robotic surgery in recent years. Surgical complications were believed to be underreported in several cases where the Da Vinci Surgical System, a type of robotic system, was used, resulting in a warning from the U.S. Food and Drug Administration in 2013.
The federal agency also warned women and doctors about the use of power morcellation used with robotic and laparoscopic surgeries to remove fibroids. The procedure uses a device to break uterine fibroids into small pieces, which can be removed through a small incision in the abdomen. If the woman also has uterine cancer, this procedure can risk spreading the cancer within the abdomen and pelvis, making it harder to treat, the FDA said at the time.
Still, the advantages of minimally invasive surgeries have been documented in many studies, doctors said.
They are associated with a shorter healing time, less pain and a lower risk of infection. Patients usually have a shorter hospital stay and return to their usual activities, including work, in a shorter period of time, Diaz-Montes said. The smaller abdominal incisions cause less tissue damage and allow faster tissue recovery. Blood loss during surgery is significantly reduced, too, and the need for blood transfusions less likely.
"It is a real game changer in the sense of recovery and quality of life right around the time of surgery," said Francis Grumbine, a gynecologic oncologist and chairman of the department of gynecology at Greater Baltimore Medical Center.
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Discovery in Morcellator Lawsuits Expedited Due to Plaintiffs’ Dire Health
Jan 22, 2016 | Injury Lawyer News
By Whitney Taylor
The health of many of the women who have filed claims against the manufacturers of power morcellators has deteriorated, prompting expedition of their legal proceedings.
The federal court overseeing the majority of power morcellator lawsuits has established steps that allow women in dire health to have priority in the discovery of their cases.
The move underscores the life-threatening consequences some women are now facing after undergoing routine hysterectomies and myomectomies using morcellation.In extremis cases given priority
The new procedure was outlined in a case management order dated January 7, 2016. The order allows living plaintiffs that are in extremis to take advantage of the special procedure that gives them priority in the discovery phase of litigation. In extremis refers to plaintiffs that are in dire health or near death and are unlikely to recovery sufficiently to provide testimony at a later time.
The court allows discovery for these plaintiffs to begin any time on or after January 11, 2016. Notice of the plaintiff’s health condition must be submitted in writing and be accompanied by a letter from the plaintiff’s treating condition. All of the in extremis cases in these coordinated proceedings must have other depositions and fact discovery completed by October 27, 2016.
Power morcellator and cancer risks
Power morcellators are devices that have been used in routine hysterectomies and myomectomies. The devices cut up the uterus and fibroids internally so they can be removed through a much smaller incision in the abdomen. Manufacturers of the devices claimed use of their products resulted in fewer complications and shorter recovery times with these procedures.
Unfortunately, it was not until these devices were used on hundreds of women that a potentially deadly side effect was discovered. Women that had undetected uterine cancer at the time of their procedure could end up with a more advanced stage of cancer after surgery, because the morcellators spread cancer cells throughout the abdomen. As the cancer was rapidly upstaged, prognosis for women after their cancer was diagnosed was significantly poorer.
Studies have determined that approximately one in every 350 women undergoing a morcellation procedure could have undetected uterine cancer. In April 2014, the FDA issued a safety communication, warning that use of these devices on women with undetected uterine sarcoma could inadvertently spread the cancer cells and make the cancer much more difficult to treat. In that communication, the FDA also discouraged the use of power morcellators in both myomectomies and hysterectomies to remove uterine fibroids.
Ethicon pulls morcellator devices
Ethicon, the company that manufactured around two-thirds of all power morcellators, announced in July 2014 that they would no longer sell the devices. They admitted at that time that there was no way to make the products safe. Since the FDA and Ethicon announcements, women who have been diagnosed with uterine sarcoma have filed lawsuits against the manufacturers of the devices, stating the companies failed to provide appropriate warning about their risks.
Lawsuits involving Ethicon were coordinated into multidistrict litigation in October last year, for the purpose of streamlining early trial proceedings and making the legal process more convenient for everyone involved. The MDL was established in U.S. District Court for the District of Kansas, where it is overseen by U.S. Magistrate Judge James P. O’Hara.
In addition to Ethicon, lawsuits have been filed against other manufacturers of morcellators, including Richard Wolf Medical Instruments, Karl Storz and Gyrus ACMI.
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Morcellation
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