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Morcellation Media Monitoring 06/23/2016
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Morcellator Cancer Risk
Jun 23, 2016 | Top Class Actions
By Paul Tassin
The risk of cancer that comes from using a morcellator to remove uterine fibroids has spawned a regulatory response as well as a wave of private litigation. -
Bill Designed to Remove Power Morcellators from Operating Room
Jun 21, 2016 | Top Class Actions
By Kim Gale
Once hailed as the MVP of laparoscopic surgery, power morcellators have been blamed for spreading cancer cells during procedures. -
Power Morcellators, Essure Birth Control System Prompt Introduction of Two Proposed Bills to Protect Consumers
Jun 22, 2016 | New Inferno
By Cynthia A. Diaz-Shephard
House legislation has recently been introduced in an effort to prompt quicker action by federal regulators to remove dangerous medical devices from the market. -
Proposed Bill would Require Doctors to Report Device Injuries to FDA
Jun 21, 2016 | News Inferno
By Lillian Chiu
Two legislators are introducing a bill that would require doctors to report deaths and injuries associated with a medical device to the U.S. Food and Drug Administration (FDA). Currently, the agency only mandates reports from hospitals and device makers. Wall Street Journal reports that the bill, known as the “Medical Device Guardian’s Act” was fueled by recent safety concerns over power morcellators.
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Jun 23, 2016 | Top Class Actions
By Paul Tassin
The risk of cancer that comes from using a morcellator to remove uterine fibroids has spawned a regulatory response as well as a wave of private litigation.
Uterine fibroids are growths that develop from the muscular tissue within the uterus. They’re actually fairly common, and usually they don’t cause symptoms.
But in some cases, uterine fibroids can cause pain, pressure, frequent urination and heavy or prolonged menstrual bleeding.
When symptoms become too severe to tolerate, some women require surgical removal of the fibroids – either through a myomectomy, which removes just the fibroids, or through a hysterectomy, which removes the uterus itself.
These procedures can be done laparoscopically, using smaller incisions that allow the patient to enjoy certain benefits like a lower risk of infection and a shorter recovery time after the surgery.
Laparoscopic surgery like this may use a power morcellator to cut up and remove fibroids or the uterus through the smaller surgical incisions.
The problem arises when the patient has uterine cancer or other nearby cancerous tissue that evades detection prior to surgery.
According to the FDA, an estimated 1 in 350 women undergoing surgery for fibroids has an unsuspected uterine cancer. The agency also says there is no reliable way to detect this type of cancer before beginning surgery.
Using a power morcellator during this surgery creates the risk that cancerous tissue, particularly that from uterine cancer, may be cut up and spread elsewhere in the abdomen and pelvis. This effect can aggravate the existing cancer and significantly worsen the patient’s chances of long-term survival.
FDA Warns About Morcellator Cancer
The FDA has addressed the issue by recommending against the use of a power morcellator for myomectomy or hysterectomy in most patients.
In a Safety Communication issued in April 2014 and updated the next November, the agency said that power morcellators should not be used to remove tissue from patients who are peri- or post-menopausal, or who are candidates for “en bloc” tissue removal.
The agency commented that most women undergoing surgery for fibroids fall within those categories.
In the same communication, the agency also announced a new recommended morcellator boxed warning advising doctors and patients about the possible risk of morcellator cancer.
The FDA itself is being investigated by the U.S. Government Accountability Office regarding the issue to find out why the agency allowed morcellators to remain on the market for twenty years before issuing a warning.
In March 2016, the FDA reported it had been notified of the investigation and that it plans to cooperate fully.
Litigation Over Morcellator Cancer
The risk that morcellator use may spread uterine cancer has led to a new wave of dozens of lawsuits against Johnson & Johnson, which manufactures the devices through its Ethicon unit.
Claims in federal court have been consolidated into a single federal court in Kansas City, Kan. Other claims against J&J have still been pending in state courts.
The company had already suspended sales of its morcellators in April 2014. Then it withdrew them from the market entirely the next July.
As of March 2016, J&J had settled about 70 of an estimated 100 morcellator lawsuits filed against the company. The company’s payouts are expected to be worth several millions of dollars. Dollar amounts of the individual settlements have reportedly ranged from $100,000 to around $1 million.
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Bill Designed to Remove Power Morcellators from Operating Room
Jun 21, 2016 | Top Class Actions
By Kim Gale
Once hailed as the MVP of laparoscopic surgery, power morcellators have been blamed for spreading cancer cells during procedures.
Now, newly introduced legislation aims to get power morcellators and other dangerous medical devices off the market.
A power morcellator is a medical device that chops and grinds tissue during laparoscopic surgery so that the small chunks of tissue can be vacuumed out through small cuts in the abdomen rather than through larger incisions used in traditional surgery.
Power morcellator complications may arise because the device scatters pieces of tissue throughout the abdominal cavity. These tiny pieces of tissue seed new growth.
Sometimes, even benign tissue can be problematic; it can grow around the intestines, causing obstructions. In other cases, previously undetected cancer cells attach to organs where new tumors grow, spreading the power morcellator cancer.
When Stage I cancer cells are taken from a centralized organ and scattered throughout the abdomen, the cancer can escalate to Stage IV very quickly.
Two different bipartisan bills have been introduced aimed at getting power morcellators off the market by making it easier for patients to sue medical device manufacturers and by requiring doctors to report adverse events.
Power Morcellator Cancer
In many cases, power morcellators were used to grind a uterus and fibrous tissue for its removal in laparoscopic surgery.
One such case claims that as a result of the morcellator’s ability to spew bits and pieces of tissue throughout the abdomen, cells – including cancer cells that had not yet been diagnosed – were disseminated throughout the woman’s body cavity and took seed, resulting in lung cancer.
Testing of the morcellated specimens were positive for leiomyosarcoma, a rare and deadly form of cancer found in connective or supportive smooth muscle tissues of the body, including that of the uterus. This power morcellator cancer metastasized to her lungs, resulting in fatal lung cancer.
Legislation Directed at Power Morcellator Complications
U.S. Representatives Louise Slaughter, D-N.Y., and Michal Fitzpatrick, R-Pa., joined forces to introduce the Medical Device Guardians Act of 2016. If passed, it would require doctors to submit reports to the FDA when problems with power morcellators or other devices were encountered during surgery.
Current law only requires hospitals and manufacturers to report such incidents.
Patient advocates fear that since physicians don’t have to report adverse events with devices that this has led to significant underreporting of power morcellator complications. Physicians already use an online database to report adverse effects of prescription drugs to the FDA, a task they are required to do by law.
Power Morcellator Lawsuits
Johnson & Johnson has settled more than 100 legal claims and lawsuits regarding its Ethicon power morcellator’s cancer-spreading potential, according to the co-lead counsel for a consolidated suit against Johnson & Johnson, as quoted in the Wall Street Journal.
Johnson & Johnson stopped sales of its power morcellator in April 2014 and took it off the market in July 2014.
“While we all agree that the majority of medical devices can and should prove to be invaluable, life-saving products,’’ Fitzpatrick said, “we must also note some well-intentioned products can cause harm and have devastating consequences on patient safety and patient health.’’
The Medical Device Guardians Act would include both existing and future medical devices.
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Jun 22, 2016 | New Inferno
By Cynthia A. Diaz-Shephard
House legislation has recently been introduced in an effort to prompt quicker action by federal regulators to remove dangerous medical devices from the market.
Two bipartisan bills are expected to ease the process for patients who have suffered due to faulty devices to sue the makers of these devices, according to Cincinnati.com. Introduction of the bills occurred earlier this month; one, the Medical Device Guardians Act of 2016, would mandate physicians to tell the U.S. Food and Drug Administration (FDA) about issues manufacturers’ devices may cause patients. The Medical Device Guardians Act would cover existing and future devices.
One such example that prompted the move is the power morcellator. Power morcellators have been routinely used in minimally invasive fibroid surgery and are constructed with “high-speed blades that cut tissue,” making the process of removing fibroid tissue easier through small incisions, wrote Cinncinati.com.
The bill’s sponsors say that it was the problems presented with use of these power morcellators, including the devices once made by Ethicon, that directly led to their proposal, Cinncinati.com noted. Only hospitals and device makers must provide this information to the FDA under current law. Patient advocates argue that this law leads to significant under-reporting and, Cinncinati.com pointed out that, today, physicians must advise the FDA about prescription drug adverse effects via an online database.
U.S. Representatives Louise Slaughter (Democrat-New York) and Michal Fitzpatrick (Republican-Pennsylvania) co-introduced the legislation after they were each approached by constituents who provided very persuasive accounts about how power morcellators led “otherwise treatable cancers to spread.” Representative Slaughter said, “What should been a routine procedure has ended with a death sentence.” She has asked the Government Accountability Office (GAO) to investigate why the FDA approved the power morcellator, which chops the uterus and/or fibroids, which may be hosting malignant cancers that have not spread. Once diced, the cancer has the opportunity to spread.
Johnson & Johnson suspended sales of Ethicon’s power morcellator in April 2014, withdrawing the device from the market in July 2014. J&J, the parent company of Ethicon, has settled in excess of 100 legal claims and lawsuits associated with the morcellators potentially cancer-spreading risk, co-lead counsel for a consolidated lawsuit against J&J told the Wall Street Journal, Cinncinati.com reported.
The second bill would enable the maker of the permanent sterilization system, Essure, to be held liable for patient harm. Essure has been tied to the deaths of at least four women.
“All of us share a similar sad story,’’ said Frank Interlichia. Mr. Interlichia’s wife died as a result of a morcellator procedure. He was speaking to some two-dozen patient advocates who traveled from all over the country to be there when the announcement of the proposed bill was made. He told the group that it was his now-deceased wife’s burning wish “to make sure this never happens to anyone else.’’
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Proposed Bill would Require Doctors to Report Device Injuries to FDA
Jun 21, 2016 | News Inferno
By Lillian Chiu
Two legislators are introducing a bill that would require doctors to report deaths and injuries associated with a medical device to the U.S. Food and Drug Administration (FDA). Currently, the agency only mandates reports from hospitals and device makers. Wall Street Journal reports that the bill, known as the “Medical Device Guardian’s Act” was fueled by recent safety concerns over power morcellators.
Power morcellators are tools that cut up tissue during a hysterectomy or myomectomy to treat uterine fibroids. According to WSJ, medical literature has shown that the tools could spread a hidden cancer since the 1990s, but the FDA was unaware until 2013. Dr. Amy Reed, who discovered that cancerous tissue had been spread during her own procedure using a morcellator, brought these concerns to light. “After that initial report from Amy, hundreds of other safety reports began to flow into the FDA,” said U.S. Reps. Mike Fitzpatrick (R., Pa.) and Louise Slaughter (D.,N.Y.) in a letter to colleagues introducing the bill. “In retrospect, it should not have fallen on patients to get the FDA’s attention,” The lawmakers assert that “everyone in the chain of care” should report these incidents to the FDA.
The FDA placed a “black box” warning in 2014, and estimated that 1 in 350 women undergoing a hysterectomy or myomectomy for fibroids had a hidden uterine sarcoma. This type of cancer cannot be detected before surgery, and using a morcellator on this cancerous tissue can spread malignancies.
The issue shed light on FDA’s system of tracking medical device injuries. In their letter, the lawmakers pointed out that Brigham and Women’s Hospital in Boston, which treated Dr. Reed, had another patient that was “harmed by a morcellator one year earlier”. The FDA, however, did not receive a report on this incident because officials felt the “device functioned as expected and was used in the way it was intended, although with unintended and tragic consequences,” a spokesperson said.
The proposed legislation would add doctors and their offices to the list of mandated reporters, and also prevents their reports from being used against them in a civil lawsuit.
The Government Accountability Office is now investigating power morcellators and numerous lawsuits have been filed. Johnson & Johnson removed its morcellator from the market in 2014, after the FDA issued its safety alert. WSJ reports that the company has settled over 100 lawsuits. Other device makers are also facing lawsuits, with more than 40 pending in a Los Angeles court against Karl Storz GmbH.
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