Preview Newsletter
Morcellation Media Monitoring 09/10/2015
-
The 18th Congressional District of Pennsylvania: The Seat of Congressional Oversight and Accountability in the United States
Sep 9, 2015 | The Philadelphia Inquirer
By Amy Reed and Hooman Noorchashm
We believe that Rep. Murphy and his subcommittee staff will rise to this occasion, where others have failed – and that they will correct a public health hazard caused by the FDA’s device section. We can only hope that Rep. Murphy will demand proper corporate accountability to Bonnie Davis and others harmed across our nation. The most powerful and sacred voice in American government is the voice of the people. We know that Rep. Tim Murphy of PA, and all congressional representatives, recognize this fact. -
Hysterectomy Complications Rise After FDA Warns Against Morcellation
Sep 8, 2015 | Reuters Health Information
By Rob Goodier
Performance of minimally invasive hysterectomies fell by 4% after the U.S. Food and Drug Administration first warned that using power morcellation to treat uterine fibroids during myomectomy or hysterectomy may pose a risk to patients with a hidden malignancy. At the same time, surgical complications rose from 2.2% to 2.8%, and readmissions within 30 days increased from 3.4% to 4.2%, according to research published online August 24 in the American Journal of Obstetrics and Gynecology. -
GAO to Scrutinize Morcellators
Sep 9, 2015 | Medical Device and Diagnostic Industry
By Marie Thibault
After a request from several legislators, the U.S. Government Accountability Office has agreed to investigate why it took so long for the public to be made aware of potential safety issues associated with laparoscopic power morcellator use, according to The Wall Street Journal. GAO's investigation follows scrutiny of morcellators from FDA and FBI. The device is used to chop up uterine tissue, facilitating removal a patient's uterus through a minimally invasive laparoscopic hysterectomy. Patient advocates say that these small pieces of tissue can be spewed around, and if they contain undetected malignant tissue, can upstage and spread cancer. There has been debate over how commonly this happens, with some disputing FDA's finding that 1 in 350 women undergoing hysterectomies or myomectomies for fibroids has an undetected uterine sarcoma. -
GAO To Launch Investigation of Morcellators
Sep 9, 2015 | American Health Line
By Julia Haskins
Last week, the Government Accountability Office confirmed that it will investigate a surgical tool for hysterectomies that has been known to spread previously undetected cancers, following a request from a bipartisan group of lawmakers, the Wall Street Journal reports (Kamp, Wall Street Journal, 9/4). -
In Light of Cancer-Spreading Risks, GAO to Investigate Power Morcellators
Sep 10, 2015 | NewsInferno
By Lillian Chiu
Cancer-spreading risks associated with laparoscopic power morcellators have prompted the U.S. Government Accountability Office (GAO) to investigate the device. According to The Wall Street Journal, the device was on the market for two decades before the U.S. Food and Drug Administration (FDA) warned that it can spread uterine cancer. Power morcellators cut up tissue into smaller pieces so that they can be more easily removed through incisions during minimally invasive procedures, most commonly hysterectomies. The tools cut out growths known as uterine fibroids. The problem is that sometimes what appears to be fibroids are actually cancer, and morcellation worsens a patient’s condition by spreading the cancerous tissue. The odds of an undetected cancer occurring in women undergoing procedures with a morcellator are 1-in-350, the FDA said last year. In November, the FDA placed a black-box warning on morcellators to notify users about the cancer risks. -
Power Morcellator Claim Alleging Medical Malpractice Filed in NJ District Court
Sep 8, 2015 | The Legal Examiner
By Steven Davis
A New Jersey woman fighting for her life in a New York hospital bed has filed a lawsuit alleging that the device maker, the hospital, and her doctors should have known about the risk posed by the power morcellator, which was used in her routine hysterectomy to remove a large fibroid last October. -
New Power Morcellator Lawsuit Filed By Pennsylvania Widower
Sep 9, 2015 | Press Release
By Tracey & Fox
Tracey & Fox has reported that a widower in Pennsylvania has filed a lawsuit against Ethicon, a division of Johnson & Johnson, on behalf of his deceased wife.Ethicon is the manufacturer of a surgical device known as the Morcellex Sigma Tissue Morcellator MX0200. This device, generally known as a power morcellator, is used in laparoscopic surgeries to slice tissue intended for removal into smaller pieces. While the morcellator cuts, it can also spread cells of the cut tissue to other internal areas. If a patient has undetected cancer and the morcellator cuts through that tumor, the cancer cells can be disseminated throughout the abdominal cavity resulting in metastasis that may have otherwise not occurred.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
-
Sep 9, 2015 | The Philadelphia Inquirer
By Amy Reed and Hooman Noorchashm
Last week the Government Accountability Office (GAO) announced that it will initiate an investigation of the FDA.
The GAO will be investigating the FDA’s process for clearance of medical devices for use in patients across the United States.
At the center of the controversy is a gynecological device known as the power morcellator.
This GAO investigation was sparked at congressional request and was spearheaded by PA congressman, Mike Fitzpatrick, and eleven of his colleagues.
This announcement by the GAO is the end result of nearly two year of grassroots campaigning by a small group of harmed patients and their families – from across the country.
However, the GAO action was only initiated, as a last resort, by one congressman (Mike Fitzpatrick) who sees the problem from the perspective of his harmed constituents – and only after it was made clear that the leadership of the senate and congressional committees on Health did not have the resolve to take spontaneous action.
Ranking chairmen of the Senate’s HELP committee and the House’s Health subcommittee, Senator Alexander (R-TN) and Rep. Pitts (R-PA), have failed to even mention the morcellator disaster in any relevant forum.
What’s more, senior HELP committee senators with affected constituents (i.e., senators Bob Casey (D-PA) and Elizabeth Warren (D-MA)) have failed to use their seats of power to drive the point home – that medical devices in the United States are not safely regulated.
Even, the chairman of the House of Representatives’ Committee on Energy and Commerce (i.e., Rep. Fred Upton), failed to support Fitzpatrick’s amendments to the recent 21st Century Cure bill, which passed overwhelmingly in the House of Representatives.
Of course, we believe that the morcellator disaster in women’s health is a far more profound problem than many congressional representatives have the courage to admit.
Simply put, the morcellator disaster in women’s health is demonstration of a terrible regulatory failure at the FDA and corporate failure on the part of device manufacturers and hospital corporations.
So, we think that the gravity and complexity of this multi-faceted public health hazard needs the intervention of the House Energy and Commerce’s subcommittee on Oversight and Investigations.
The Committee on Oversight and Investigations is chaired by Rep. Tim Murphy of Pennsylvania’s 18th congressional district.
In fact, Rep. Murphy has a very personal reason to engage the power morcellator disaster in women’s health with care. That reason is Ms. Bonnie Davis of PA.
Ms. Davis is a resident of the 18th congressional district in PA – Rep. Murphy’s own district. Her uterine cancer was spread by a power morcellator - and she is now fighting an aggressive morcellated stage 4 cancer.
We believe that Rep. Murphy and his subcommittee staff will rise to this occasion, where others have failed – and that they will correct a public health hazard caused by the FDA’s device section. We can only hope that Rep. Murphy will demand proper corporate accountability to Bonnie Davis and others harmed across our nation.
The most powerful and sacred voice in American government is the voice of the people. We know that Rep. Tim Murphy of PA, and all congressional representatives, recognize this fact.
Mr. Murphy is now aware that, a family has been victimized by a failure in federal regulation and corporate misbehavior in his congressional district. We can only hope that he will raise an eyebrow and lead his colleagues to oversee and to investigate.
The House subcommittee on Oversight and Investigation wields the power to correct this severe public health hazard – and now its ranking chairman has a reason to do so that hits home. -
Hysterectomy Complications Rise After FDA Warns Against Morcellation
Sep 8, 2015 | Reuters Health Information
By Rob Goodier
Performance of minimally invasive hysterectomies fell by 4% after the U.S. Food and Drug Administration first warned that using power morcellation to treat uterine fibroids during myomectomy or hysterectomy may pose a risk to patients with a hidden malignancy.
At the same time, surgical complications rose from 2.2% to 2.8%, and readmissions within 30 days increased from 3.4% to 4.2%, according to research published online August 24 in the American Journal of Obstetrics and Gynecology.
"Understanding all the real world effect of these national safety communications is important for patients, providers, and policy makers," lead author Dr. John Harris of the University of Michigan in Ann Arbor told Reuters Health by email.
The FDA began discouraging the technique in women with fibroids in response to concerns that morcellation may spread occult uterine leiomyosarcoma.
The researchers compared surgical techniques and complications in 9,597 hysterectomies during the 15 months before and 5,775 in the first eight months after the FDA's first safety warning on April 17, 2014.
While laparoscopic hysterectomies decreased, abdominal hysterectomies increased by 1.7% and vaginal procedures increased by 2.4%.
Both before and after the FDA warning, laparoscopic and vaginal surgeries had roughly similar rates of post-operative complications, at 2.7% to 3.4% for laparoscopy and 3.1% for vaginal procedures. But abdominal surgery had a complication rate of 9.7% to 10.2%.
The median risk-adjusted cost of the increased readmissions after the FDA warning was $5,847.
"The evidence is clear that there are significant benefits to a minimally invasive approach to hysterectomy, which includes the vaginal route," said Dr. Matthew Siedhoff at the University of North Carolina at Chapel Hill, who was not involved in the research.
"Even accounting for the possibility of occult malignancy, abdominal hysterectomy results in higher rates of wound infection, hernia, venous thromboembolism, transfusion, and even death. The abdominal route is costlier, patients spend longer in the hospital, and they are out of work for greater periods of time, adding societal burden," Dr. Siedhoff says.
Simply switching to abdominal surgery is reactionary, but the debate may have the benefit of raising awareness of the risks of each method, Dr. Siedhoff says.
"I believe the best way to address this problem is to continue to investigate and publish in the medical literature on issues we incompletely understand - the risk of occult malignancy in the setting of large fibroids and the impact on patient outcomes - as well as ways we can reduce risk further through improved preoperative identification and specimen containment," Dr. Siedhoff said.
-
GAO to Scrutinize Morcellators
Sep 9, 2015 | Medical Device and Diagnostic Industry
By Marie Thibault
After a request from several legislators, the U.S. Government Accountability Office has agreed to investigate why it took so long for the public to be made aware of potential safety issues associated with laparoscopic power morcellator use, according to The Wall Street Journal.
GAO's investigation follows scrutiny of morcellators from FDA and FBI. The device is used to chop up uterine tissue, facilitating removal a patient's uterus through a minimally invasive laparoscopic hysterectomy. Patient advocates say that these small pieces of tissue can be spewed around, and if they contain undetected malignant tissue, can upstage and spread cancer. There has been debate over how commonly this happens, with some disputing FDA's finding that 1 in 350 women undergoing hysterectomies or myomectomies for fibroids has an undetected uterine sarcoma.
The Wall Street Journal reported recently that GAO has said it will examine the issue and plans to start in about five months, once personnel are free to spend time on it. The investigation was spurred by an August letter, signed by a dozen Congress members, petitioning GAO to look into the regulatory clearance, marketing, training, and adverse event reporting associated with morcellator use. Additionally, it asks the watchdog to determine what FDA is doing to ensure the devices, which are still commercially available from some companies, are safe.
Physicians and patient advocates Dr. Hooman Noorchashm and Dr. Amy Reed, authored a blog post for Philly.com on the legislators' letter, praising the signers and urging other members of Congress to get involved. Reed had a hysterectomy with a power morcellator in late 2013 and was diagnosed soon after with advanced stage uterine sarcoma. Reed and Noorchashm have been vocal supporters of a ban on morcellators and are working toward CDRH reform.
In their Philly.com piece, Noorchashm and Reed wrote, "We know that if a GAO investigation is done properly and with care, it will provide information and insight into a wide-scale and severe public health threat—one, which no congressional representative can justify ignoring."
Back in May, The Wall Street Journal reported that the FBI was examining morcellators too. In 2014, FDA published safety communications about power morcellation and maker Johnson & Johnson issued a voluntary recall of its power morcellators. Several health insurers, including Highmark and United Healthcare, have said they will not cover use of morcellators during hysterectomies. A number of health systems and hospitals have stopped performing hysterectomies with morcellation.
-
GAO To Launch Investigation of Morcellators
Sep 9, 2015 | American Health Line
By Julia Haskins
September 09, 2015
Last week, the Government Accountability Office confirmed that it will investigate a surgical tool for hysterectomies that has been known to spread previously undetected cancers, following a request from a bipartisan group of lawmakers, the Wall Street Journal reports (Kamp, Wall Street Journal, 9/4).
BACKGROUND >>>
Laparoscopic power morcellation was developed in the 1990s as an alternative to invasive surgery for women with symptomatic uterine fibroids, which are benign tumors in the uterus wall that are responsible for about 40% of the 500,000 hysterectomies performed in the U.S. each year. Until recently, the device was used in about 50,000 procedures annually in the U.S.The technique came under fire for its potential to spread a certain type of cancer -- known as a uterine sarcoma -- within the body. A study published last year in the Journal of the American Medical Association estimated that one in 368 women undergoing morcellation had uterine cancer that was undetected until after the procedure.
In April 2014, FDA issued a rare safety communication notice discouraging the use of the procedure. In November 2014, FDA called for an immediate "black box" warning for laparoscopic power morcellators. The black box warning is the strongest warning that the agency issues. However, it falls short of issuing a market-wide recall of the devices, for which some opponents of the tool had called.
Many hospitals and large insurers have either scaled back their use or coverage of the devices or are considering setting limits.
In May, the FBI launched an investigation to determine whether hospitals, physicians and makers of medical devices broke the law by not reporting issues when the tool was used during gynecologic surgery.
FDA has approved at least 10 power morcellators for sale since the first device went on the market. While device applications and other records showed FDA knew early on about the risk of morcellation, the agency said the degree of the problem was not brought to light until late 2013.
Last year the agency warned women undergoing morcellation had an estimated one in 350 chance of having a hidden cancer that the device could spread and exacerbate.
Last month, a bipartisan group of lawmakers sent a letter to the Government Accountability Office requesting the investigation (American Health Line, 8/11).
Investigation Details
In a letter sent last week to Fitzpatrick, Katherine Siggerud, managing director for congressional relations at GAO, said the agency would move forward with an investigation "as work that is within the scope" of GAO authority. Siggerud said it was still unclear how long an investigation might take, but that GAO probably would have staff available to begin the probe in about five months.
An FDA spokesperson said that the agency will cooperate with a GAO investigation (Wall Street Journal, 9/4).
-
In Light of Cancer-Spreading Risks, GAO to Investigate Power Morcellators
Sep 10, 2015 | NewsInferno
By Lillian Chiu
Cancer-spreading risks associated with laparoscopic power morcellators have prompted the U.S. Government Accountability Office (GAO) to investigate the device. According to The Wall Street Journal, the device was on the market for two decades before the U.S. Food and Drug Administration (FDA) warned that it can spread uterine cancer.
Power morcellators cut up tissue into smaller pieces so that they can be more easily removed through incisions during minimally invasive procedures, most commonly hysterectomies. The tools cut out growths known as uterine fibroids. The problem is that sometimes what appears to be fibroids are actually cancer, and morcellation worsens a patient’s condition by spreading the cancerous tissue. The odds of an undetected cancer occurring in women undergoing procedures with a morcellator are 1-in-350, the FDA said last year. In November, the FDA placed a black-box warning on morcellators to notify users about the cancer risks.
Last month, twelve lawmakers wrote a letter to the GAO asking the government watchdog to investigate morcellators. Katherine Siggerud, managing director for congressional relations at the GAO, said “We’ve agreed to do the work,” according to WSJ. The agency sent a letter to Rep. Mike Fitzpatrick (R., Pa.), who was at the forefront of the action, saying they accepted the requiest “as work that is within the scope”, Siggerud told WSJ. She said that the timeline for the probe was uncertain, but staff is likely to be available to start working on the issue in five months.
WSJ reports that the FDA will likely face heightened criticism due to the investigation, which will look closely at how the agency handled the devices since the first one hit the market in 1991. Records, including device applications, indicate the FDA was aware of cancer-spreading risks with morcellators early on. However, the agency said severity of these risks were not clear until 2013. “I am glad the GAO has agreed to take up this investigation,” said Mr. Fitzpatrick said in a statement., according to WSJ. “What happened with the power morcellator should never happen again.”
The letter lawmakers sent to the GAO asked the agency to probe the capabilities of a regulatory process used to approve morcellators. The process has been under scrutiny for having lax requirements. Additionally, the lawmakers want to know whether problems with morcellators were properly reported, how doctors were trained and what the FDA is doing to evaluate their safety on the market.
-
Power Morcellator Claim Alleging Medical Malpractice Filed in NJ District Court
Sep 8, 2015 | The Legal Examiner
By Steven Davis
A New Jersey woman fighting for her life in a New York hospital bed has filed a lawsuit alleging that the device maker, the hospital, and her doctors should have known about the risk posed by the power morcellator, which was used in her routine hysterectomy to remove a large fibroid last October.
Plaintiff Alleging Medical Malpractice
Only weeks after her surgery, the woman filing the lawsuit was diagnosed with Stage 4 leiomyosarcoma, a rare, aggressive, and incurable form of cancer that she alleges was spread by the power morcellator. In addition to naming the device manufacturer, Karl Storz Edoscopy-America, this New Jersey lawsuit also adds medical malpractice claims against the woman’s hospital and health care providers, claiming that they should have known of the potential dangers of morcellation, informed her of those dangers, and obtained her consent before surgery.
Named in the lawsuit are the woman’s gynecologic oncologist, gynecologist, and anesthesiologist, as well as the device manufacturer Karl Storz Endoscopy-America, Inc. and The Valley Hospital in Ridgewood, New Jersey. A judge in federal district court in New Jersey recently agreed to the plaintiff’s request that her testimony be taken immediately, from her hospital room if necessary, because she might not live to attend the trial, according to her attorney.
How Does a Power Morcellator Work?
The morcellator is used to cut and shred tissue so it could be removed from the body through a small opening during minimally invasive surgical procedures. As the morcellator chops up tissue, it can disperse it throughout the abdomen, where the cells can attach to the intestines or intestinal wall, or spread to other areas of the body. If the tissue contains cancer cells, morcellation can cause immediate upstaging of the disease, taking it from a potentially treatable Stage 1 cancer to Stage 4 terminal cancer.
An estimated 600,000 hysterectomies are performed annually in the U.S., and the FDA first approved power morcellators in 1991, paving the way for doctors to do minimally invasive hysterectomies. The FDA has revised its assessment of the cancer risk associated with morcellation, estimating that one in every 350 women who undergoes a hysterectomy for fibroids has an undetectable cancer that could be spread by morcellation.
-
New Power Morcellator Lawsuit Filed By Pennsylvania Widower
Sep 9, 2015 | Press Release
By Tracey & Fox
Tracey & Fox has reported that a widower in Pennsylvania has filed a lawsuit against Ethicon, a division of Johnson & Johnson, on behalf of his deceased wife.
Ethicon is the manufacturer of a surgical device known as the Morcellex Sigma Tissue Morcellator MX0200. This device, generally known as a power morcellator, is used in laparoscopic surgeries to slice tissue intended for removal into smaller pieces. While the morcellator cuts, it can also spread cells of the cut tissue to other internal areas. If a patient has undetected cancer and the morcellator cuts through that tumor, the cancer cells can be disseminated throughout the abdominal cavity resulting in metastasis that may have otherwise not occurred.
The lawsuit was filed in the United States District Court for the Eastern District of Pennsylvania under case number 2:15-cv-00553-JHS, and alleges that the deceased wife of the plaintiff died because her undiagnosed uterine cancer was spread throughout her body by the Morcellex Sigma Tissue Morcellator MX0200. On June 19th, 2012, she underwent a laparoscopic surgery known as a robotic total laparoscopic hysterectomy for the removal of uterine fibroids. Her surgeon used the power morcellator to remove the uterus.
Prior to her surgery, the patient had pre-surgical testing performed which showed no evidence of uterine cancer. Then, a biopsy of one of the uterine fibroids that were removed during her hysterectomy, returned with a diagnosis of leiomyosarcoma. The biopsy report stated that “the size and extent of the tumor cannot be assessed due to morcellation.”
Following her initial surgery, the patient had a robotic lymphandenectomy, bilateral salpingo-oophorectomy, and lysis of adhesions and peritoneal biopsy. Leiomyosarcoma was also found in her right fallopian tube and on January 9th, 2013, additional malignant cells were found in other regions of the abdominal cavity. Less than a month later she passed away.
The lawsuit alleges that the widower and his wife were never warned of the risks associated with the use of a power morcellator during her hysterectomy and in fact the “plaintiff’s were prevented from discovering this information sooner because the defendants herein misrepresented to the public and to the medical professional that the Laparoscopic Power Morcellator used on the plaintiff-decedent was safe to use for laparoscopic gynecologic surgery.”
The U.S. Food and Drug Administration released a safety warning in 2014, urging surgeons to stop using the power morcellator during gynecological laparoscopic surgeries.
For more information regarding this press release, call Tracey & Fox at (713) 322-5375.
Read more: http://www.digitaljournal.com/pr/2668519#ixzz3lLVZ0A3k
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
Add recipients
Suggested