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Morcellation Media Monitoring 06/08/2015
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Surgical tool comes under scrutiny
Jun 6, 2015 | Poughkeepsie Journal
By Karen Maserjian
When it comes to surgeries, minimally invasive operations allow for smaller incisions and shorter recovery times than open operations do. -
Popular Surgical Tool Under Federal Investigation
Jun 5, 2015 | WSPA-7 (CBS - Spartanburg, S.C.)
By Dave Jordan
A popular surgical tool is part of a federal investigation to see if it's use could cause undetected cancers to spread and whether doctors and hospitals lied about its safety. -
Johnson & Johnson Morcellator Device Spreads Cancer
Jun 4, 2015 | The Legal Examiner
By Craig Kelley
Once again Johnson & Johnson shows its true colors in allowing a defective, dangerous product to be used in real live patients. Johnson & Johnson recalled and withdrew from the market a power morcellator used in laparoscopic hysterectomy surgeries. -
AHIP Institute begins with emphasis on innovation to help consumers
Jun 4, 2015 | FierceHealth Payer
By Brian Eastwood
America's Health Insurance Plans kicked off its annual AHIP Institute with a call for innovation and a surprise appearance from outgoing President and CEO Karen Ignagni.
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Surgical tool comes under scrutiny
Jun 6, 2015 | Poughkeepsie Journal
By Karen Maserjian
When it comes to surgeries, minimally invasive operations allow for smaller incisions and shorter recovery times than open operations do.
But not all operations are candidates for minimally invasive surgeries and even for those that are, a full consideration of all aspects of the surgery should be assessed before the operation is performed.
One point is the equipment employed for the surgeries, in particular, laparoscopic power morcellators that are sometimes used during minimally invasive hysterectomies, which involve the removal of the uterus, and myomectomies, where uterine fibroids are removed.
A laparoscopic power morcellator is a surgical tool that's used to break up internal specimens or tissue that are otherwise too large to remove through a small physical opening or incision. In 2014, the Food and Drug Administration recommended against using laparoscopic power morcellators in most surgeries involving the removal of uterine tissue containing fibroids, including those for peri- or post-menopausal women and gynecologic operations where the morcellation would involve tissue that was known or suspected to contain cancer.
The issue is when laparoscopic power morcellators are used on women that have uterine sarcoma, a rare and often undetected cancer in the muscle around the uterus, there's a chance the cancer will spread.
Currently the FDA estimates of the women that have a hysterectomy or myomectomy for fibroid treatment, about 1 in 350 of them has an unsuspected uterine sarcoma. Furthermore, there's no absolute test to confirm whether or not a woman with fibroids has a uterine sarcoma.
Jed L. Turk, a Fishkill-based medical doctor who specializes in obstetrics/gynecology with Health Quest Medical Practice, said laparoscopic power morcellators have been around since the early 1990s and have been in use for more than 20 years, with their technology improving over time.
He said while laparoscopic power morcellators have been useful in allowing patients to have laparoscopic — that is, minimally invasive —procedures instead of traditional surgeries that involve opening the abdomen, operating with the tool isn't without risks.
"The risk of morcellation is not so much cancer," he said, as uterine sarcoma is rare. "There's an increased risk of surgical injury."
Even so, Turk said, in no instance should patients with suspected or documented cancer have the surgery with morcellation, which breaks up tissues, causing some fragments to cast about the surgical cavity. In all cases, Turk said patients should discuss their surgical options with their doctor, especially since there's no way to test for uterine sarcoma prior to surgery.
"Every procedure we do, every step, always has risks and benefits," he said. "You have to be careful of the risk/benefit ratio."
According to the American College of Obstetricians and Gynecologists' 2011 Women's Health Stats and Facts report, as many as 80 percent of women have uterine fibroids, most commonly in those between the ages of 30 and 40. The benign growths, which don't always need to be removed as they are non-cancerous and tend to shrink after menopause, cause symptoms in 25 percent to 50 percent of women, and are behind almost 39 percent of all hysterectomies performed annually in the U.S.
The report also showed approximately 31 percent of inpatient hysterectomies were done vaginally in 2008, with about 9 percent of all inpatient hysterectomies performed using a laparoscope, and about 13 percent done as laparoscopically-assisted vaginal hysterectomy.
"The American College of Obstetricians and Gynecologists shares the Food and Drug Administration's commitment to the health and well-being of American women," medical doctor Hal C. Lawrence, executive vice president and CEO of the ACOG, said in a 2014 written statement released by the organization. "… As we have said in the past, we continue to believe that power morcellation has a role in gynecologic surgery. Power morcellation can make it possible for some women to undergo less-invasive laparoscopic hysterectomy or myomectomy, sparing them the longer recovery time and higher mortality rates associated with a total abdominal procedure. The FDA's clarification of contraindications for morcellation will help to ensure that only women at low risk for an occult malignancy will undergo laparoscopic hysterectomy or myomectomy with morcellation."
Casey MacDonald, founder and executive director of The Cancer Resource Center of the Hudson Valley in Montgomery, Orange County, said although uterine sarcoma is a rare cancer, it's aggressive, so women with uterine fibroids that need to be removed should get a second opinion on their treatment, especially since morcellation can spread the cancer.
"Get your doctor to define for you what the problem is and how necessary it is to treat it," she said. "A lot of times we treat things that may be fine if left alone. Sometimes we feel like we're not given that option."
It's best to consult with doctors that are experienced in fibroid removal, she said, and to talk with them about treatment options and which procedure is a good fit for their condition, as there are different methods that can be used to remove fibroids.
"Ask, 'What are complications that are involved here?' 'How often do they occur?' 'What are the results of the doctors' surgeries?' " MacDonald said. "A lot of times, too, ask doctors, 'Are you the one to be performing this?' 'Should I be consulting someone else?' "
When it comes down to it, patients need to assess whether their risk for treatment outweighs the benefits or the benefits outweigh the risks.
"It's just very good patient advocacy when you can advocate for yourself and know that you're walking out of your doctor's office with all the information you need to make an important decision," MacDonald said.
Turk said one option to having a hysterectomy or myomectomy without laparoscopic power morcellation is a traditional open surgery. In some cases another option is a minimally invasive operation that doesn't involve the use of a power morcellator. Here, one or several fibroids would be dissected first to reduce the size of the uterus, allowing for its removal vaginally. Still another method is a sort of hybrid laparoscopic/open operation, where one of the laparoscopic incisions would be widened or a small, low incision would be made from which the uterus would be removed.
Currently, Turk said some laparoscopic power morcellator manufacturers are looking into safer solutions in their use, including the possibility of a bagged design that collects fragmented tissue.
"I do think there's a place for power morcellators," Turk said. "It shouldn't be used without regard to patient risks. Patients need to understand the benefits and never be afraid to ask their doctors questions."
Karen Maserjian Shan is a freelance writer: mkshan@optonline.net
Hysterectomy facts
- Hysterectomy is one of the most frequently performed surgical procedures in the U.S.
- During 2000-2004, approximately 3.1 million hysterectomies were performed, or about 600,000 per year.
- The most common indications for hysterectomy are symptomatic uterine leiomyomas (40.7 percent), endometriosis (17.7 percent) and prolapse (14.5 percent).
- Hysterectomies are performed vaginally, abdominally, or with laparoscopic or robotic assistance.
- Most literature supports the opinion that, when feasible, vaginal hysterectomy is the safest and most cost-effective route by which to remove the uterus.
- In the U.S., abdominal hysterectomy is performed in 66 percent of cases, vaginal hysterectomy in 22 percent of cases and laparoscopic hysterectomy in 12 percent.
Source: www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Choosing-the-Route-of-Hysterectomy-for-Benign-Disease
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Popular Surgical Tool Under Federal Investigation
Jun 5, 2015 | WSPA-7 (CBS - Spartanburg, S.C.)
By Dave Jordan
A popular surgical tool is part of a federal investigation to see if it's use could cause undetected cancers to spread and whether doctors and hospitals lied about its safety.
The FBI launched an investigation into morcellators, a device used to cut up tissue during surgery so it could be easily removed. Last November, the Food and Drug Administration warned against using morcellators during surgery in the “vast majority of women” to reduce the spread of cancer in women having hysterectomies or fibroid removal surgery.
“It's been known that invasive surgery can do that with cancer for quite a while,” said Neil Caesar, an attorney and president of the Health Law Center. “I would think that's the kind of concern that would have been thought through during the stages of testing and release of the device."
Caesar believes FBI will likely look at whether that well-known fact was ignored by manufacturers when the morcellators were being tested. And, he says, there is another concern.
“For now, it seems perhaps that it has to do with whether the hospitals that have had these adverse events happen had adequately reported them to the FDA," Caesar said.
Greenville Hospital System and Self-Regional Hospital in Greenwood no longer use morcellators. An-Med said it uses one under limited circumstances and warns patients about the dangers. A spokeswoman for Spartanburg Regional did not get back to us by deadline.
Last year, Morcellator-Maker Johnson and Johnson issued a voluntary recall of the device amid those FDA concerns. Other versions are still on the market. Caesar says as long as the device is in use, the federal investigation will likely expand. -
Johnson & Johnson Morcellator Device Spreads Cancer
Jun 4, 2015 | The Legal Examiner
By Craig Kelley
Once again Johnson & Johnson shows its true colors in allowing a defective, dangerous product to be used in real live patients. Johnson & Johnson recalled and withdrew from the market a power morcellator used in laparoscopic hysterectomy surgeries. These surgeries were of the minimally invasive variety, with the morcellator grinding up uterine fibroid tissue to be removed by very, very small incisions. The problem is that this device has been found to endanger women, rather than help them, by actually spreading cancer throughout a woman’s pelvis and abdomen, “significantly worsen…the patient’s likelihood of long-term survival,” a quote from the U.S. Food and Drug Administration.
This medical device is being touted as so dangerous that the Federal Bureau of Investigation has gotten involved. Prior to Johnson & Johnson’s withdrawal of the instrument, and advice to doctors to immediately stop using it, an estimated sixty thousand surgeries using it were done per year! Innocent women going into surgery believing their cancerous tissue could be eradicated have had their cancer spread instead. When will Johnson & Johnson and other such companies put the life of a patient above making money?
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AHIP Institute begins with emphasis on innovation to help consumers
Jun 4, 2015 | FierceHealth Payer
By Brian Eastwood
America's Health Insurance Plans kicked off its annual AHIP Institute with a call for innovation and a surprise appearance from outgoing President and CEO Karen Ignagni.
"It's been such a marvelous opportunity to represent each and every one of you," said Ignagni (pictured right), who added that she was speaking at the event for the first time in 22 years as the lobbying group's leader.
Ignagni is leaving AHIP in September to become President and CEO of New York-based nonprofit insurer EmblemHealth. She described her appearance at the event as "incredibly bittersweet" and praised payers for their willingness to take on initiatives such as care coordination, better disease prevention and care delivery reform at a time when payment reform has forced the insurance industry to "turn entire products upside down."
Ignagni told attendees that AHIP will continue to represent the industry--and that she will not be a stranger. "I look forward to coming back next year and continuing to work in this great industry," she said.
It's an industry that must be ready to change, said Rodney F. Hochman, M.D., president and CEO of Providence Health & Services, an integrated delivery network based in Washington state.
Hochman, who spoke during AHIP Institute's opening panel, said his system's last 12 hires have all come from Amazon--and "they are shocked at our lack of consumer focus." Some Providence employees struggled with this cultural change and left the organization, but "most accepted that the industry needed to move forward."
In addition to improving its digital platform--one of the 12 former Amazon employees helped develop the Kindle tablet--Hochman said Providence concentrates its innovative efforts on improving population health management and strengthening its core services as opposed to expanding. "Innovation over scale is the way we're going to solve healthcare issues," he said.
At the same time, organizations cannot simply innovate for innovation's sake, said David Holmberg, president and CEO of Highmark Health. That can lead to expensive, and sometimes unnecessary, technology investments. Rather, Holmberg said, insurers should hone in on innovations that will improve outcomes while lowering costs.
Highmark has made waves under Holmberg's leadership for ending coverage of costly and potentially dangerous power morcellator procedures and suing the University of Pittsburgh Medical Center for $300 million in cancer claims overcharging, FierceHealthPayer previously reported.
Holmberg mentioned both moves during the panel discussion and said they show how insurers can "change the game" if they focus on doing the right thing. "We need to make healthcare smarter, make it simpler and make it care for everyone," he said. "To change care, you have to stand for something."
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Morcellation
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