Preview Newsletter
Morcellation Media Monitoring 08/17/2015
-
Dying woman sues her New Jersey doctors for using a hysterectomy device that the FDA says can spread cancer
Aug 14, 2015 | New York Daily News
By Ashley Lewis
A 43-year-old New Jersey mother is lying on her death bed, her body racked with cancer a year after she underwent a hysterectomy, and she’s blaming her doctor for using a controversial device in the procedure. Viviana Ruscitto is suing her oncologist, Dr. Howard Jones, for malpractice, alleging he used a device that she blames for spreading cancer cells in her uterus throughout her internal organs. -
Woman Fighting For Life Claims Surgical Tool Spread Cancer
Aug 17, 2015 | Newsy
By Christine Slusser
View Clip Here: http://www.newsy.com/videos/woman-fighting-for-life-claims-surgical-tool-spread-cancer/ Rough Transcript: A mother who went in for a routine hysterectomy in New Jersey is now fighting for her life after she says a tool used during the surgery caused cancer to spread. Viviana Ruscitto has been diagnosed with stage 4 uterine cancer. She is blaming the use of a surgical tool called a power morcellator. -
From hospital bed, cancer patient presses device suit that blames N.J. doctors, manufacturer – News – NorthJersey
Aug 17, 2015 | The Suffield Times
By Bill Morgan
Viviana Ruscitto, the mom of a toddler, is preventing for her life in a New York hospital mattress. She is affected by a extremely aggressive type of most cancers that, she believes, was unfold by a tool used throughout what was purported to be a routine hysterectomy. -
Without more monitoring, medical devices will keep harming patients
Aug 13, 2015 | Lexington Herald-Leader
By Kevin Kavanagh
A caller to Jack Pattie's radio show recently asked a disturbing question: Are patients guinea pigs for medical devices? I responded that medical devices are often poorly tested and if I received a faulty one, guinea pig would be the mildest term I would use. In fact, we are not even guinea pigs, we are sacrificial lambs for corporate profits. When a guinea pig is used in an experiment, data are collected to improve the product. Not so with medical devices. There is little effective post-market monitoring of these devices.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
-
Aug 14, 2015 | New York Daily News
By Ashley Lewis
A 43-year-old New Jersey mother is lying on her death bed, her body racked with cancer a year after she underwent a hysterectomy, and she’s blaming her doctor for using a controversial device in the procedure.
Viviana Ruscitto is suing her oncologist, Dr. Howard Jones, for malpractice, alleging he used a device that she blames for spreading cancer cells in her uterus throughout her internal organs.
“My sister’s prognosis is poor, and I do not know how much longer she can continue fighting this cancer,” Mirian Riviera told a judge last week in a sworn statement.
Ruscitto had a minimally invasive hysterectomy performed in October 2014 to remove a large fibroid in her uterus at The Valley Hospital in Ridgewood, N.J.,The Record reported.
Jones used a controversial surgical tool, a power morcellator, to cut and tear tissue so it could be removed from her body.
The device was approved to remove uterine fibroids in 1991 because the small incisions from morcellation helped patients recover quicker and easier.
The device has come under heavy scrutiny in recent years, however, and in April 2014 the FDA released a safety alert against morcellators, acknowledging that the device can spread undetected cancer cells.
The agency said some of the minced undetected cancerous tissue fragments could be left behind in the abdominal cavity and spread to other parts of the body.
The government discouraged doctors from using the morcellators and encouraged professionals to discuss the risks and benefits with their patients.
The device’s largest manufacturer, Ethicon, a division of Johnson & Johnson, promptly pulled the morcellator off the market.
Despite these warnings, Jones allegedly continued using the tool and did not perform a pre-operative biopsy on Ruscitto or discuss the risks with her, the suit said.
“We will not be commenting on this matter,” Maureen Curran Kleinman, a spokesman for The Valley Hospital where Jones and her gynecologist Dr. Eugenia C. Kuo work., said.
Her lawyer, Demetrios Stratis, argued that the healthcare providers should have informed her, and obtained her consent, before using the morcellator.
“She specifically told (the doctor) that she had tremendous anxiety of ovarian cancer,” the lawsuit said.
Weeks after the procedure, Ruscitto was diagnosed with incurable Stage 4 leiomyosarcoma weeks later.
“If those procedures are going to be done, they have to be carefully screened,” Dr. Mark Morgan, director of the Hospital of the University of Pennsylvania Division of Gynecologic Oncology at Pennsylvania Hospital, told the Daily News. “There can’t be anything suspicious about it. If anything is out of the usual, it shouldn’t be done.”
Ruscitto is suing her doctors, the hospital and device maker Karl Storz Endoscopy.
The FDA recently reassessed and increased the risk of undetected aggressive cancer cells in women undergoing a hysterectomy for fibroids from one in 500 to one in 352, The New York Times reported.
But sarcoma cells are tricky to detect in a biopsy, doctors say, and that could make it hard for Ruscitto to pin blame on the doctor’s use of a power morcellator.
“Even if you don’t see them spread, about 50% of them will recur anyway before you took the uterus out,” Morgan said. “It may have spread already, so that being said, you may not be making it worse by morcellating it.”
This is the third suit filed in New Jersey and one of two dozen filed in the country involving cancer spread by morcellation.
“With the FDA warnings, with the companies that stopped making them, I think I would in general not advise doing (morcellation),” Morgan said.
-
Woman Fighting For Life Claims Surgical Tool Spread Cancer
Aug 17, 2015 | Newsy
By Christine Slusser
View Clip Here: http://www.newsy.com/videos/woman-fighting-for-life-claims-surgical-tool-spread-cancer/
Rough Transcript: A mother who went in for a routine hysterectomy in New Jersey is now fighting for her life after she says a tool used during the surgery caused cancer to spread.
Viviana Ruscitto has been diagnosed with stage 4 uterine cancer. She is blaming the use of a surgical tool called a power morcellator.
Morcellators are used in laparoscopic, or minimally invasive, surgery. They chop up tissue so it can be taken out of the body through a small opening. The 43-year-old patient says she believes the tool spread the cancer around.
Ruscitto filed a lawsuit against the hospital, several doctors and the company that makes the tool.
There is already a class action lawsuit for women who had surgery using morcellators and who developed cancer within two years of having procedures to remove fibroids, ovaries, fallopian tubes or the uterus.
A Fox News medical correspondent said morcellators need to go.
"If you're still using a morcellator, that's a huge mistake. ... Once the cancer starts to spread, these women will have stage 4 of the disease," Dr. David Samadi told Fox News. (Video via Fox News)
The FDA has also released a warning against morcellators, especially in women suspected to have cancer.
"The FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids."
That statement was released in April 2014 and originally said it discouraged the use of morcellators. The statement was then updated in November to say it was warning against the use. Ruscitto's surgery was in October of that year.
Ruscitto is currently undergoing chemotherapy. The FDA says 1 in 350 have unsuspected cancer and are at risk for that cancer spreading after hysterectomy or myomectomies.
-
Aug 17, 2015 | The Suffield Times
By Bill Morgan
Viviana Ruscitto, the mom of a toddler, is preventing for her life in a New York hospital mattress. She is affected by a extremely aggressive type of most cancers that, she believes, was unfold by a tool used throughout what was purported to be a routine hysterectomy.
A surgical device referred to as an influence morcellator was used to chop and shred tissue so it could possibly be sucked out via a tiny opening in the course of the minimally invasive operation. Ruscitto, 43, believes it spattered most cancers cells via her stomach.
In a lawsuit filed in federal courtroom in Newark, she contends it ought to by no means have been used for her surgical procedure at The Valley Hospital in Ridgewood final fall. Six months earlier than her operation to take away a big fibroid, the federal authorities had discouraged health-care professionals from utilizing morcellators due to the danger of spreading undetected most cancers cells. The most important producer of the system had already suspended gross sales.
“My sister’s prognosis is poor, and I have no idea how for much longer she will proceed preventing this most cancers that’s attacking her physique so fiercely,” Mirian Rivera advised a decide final week in a sworn assertion. “Our mom and I take turns staying together with her on the hospital, whereas our father is at house taking good care of her 2-year-old son, Maximo.”
Ruscitto has been recognized with Stage four leiomyosarcoma, a uncommon and aggressive most cancers.
She has sued the gadget maker, her docs and Valley, charging that they need to have recognized concerning the danger posed by the system.
A decide in federal district courtroom agreed final week to her lawyer’s request to take her testimony instantly — in her room at Memorial Sloan Kettering Most cancers Middle, if needed. She might not stay to attend the trial, the lawyer, Demetrios Stratis, stated.
The metastases have unfold shortly, obstructing her intestines and inflicting a lot swelling she seems to be 9 months pregnant, Rivera advised the courtroom. Ruscitto, who lives in Higher Nyack and has been the radiology director of a Westchester County radiology facility, is not present process chemotherapy to struggle the illness. She is receiving oxygen, morphine and anti-nausea treatment.
Ruscitto’s go well with is the third filed in U.S. District Courtroom for New Jersey involving most cancers that was allegedly unfold by a morcellator, and it’s one among almost two dozen across the nation. The others – towards 4 system makers, together with Karl Storz Endoscopy-America Inc., which is known as in Ruscitto’s go well with, and Ethicon, a subsidiary of Johnson & Johnson — are being thought-about by the Judicial Panel on Multidistrict Litigation for consolidation.
Karl Storz Endoscopy didn’t reply to requests for remark.
Ruscitto’s case is totally different from the others, her lawyer says, as a result of it consists of malpractice claims towards the hospital and her docs, Howard H. Jones, a gynecologic oncologist; Eugenia C. Kuo, a gynecologist; and Celeste A. Telfeyan, an anesthesiologist.
Stratis argues that when Ruscitto had surgical procedure Oct. 17, there had already been a lot publicity concerning the potential risks of energy morcellators that the well being care suppliers ought to have recognized, knowledgeable her and secured her consent earlier than the surgical procedure.
She “particularly advised him [Jones] that she had large nervousness of ovarian most cancers,” the lawsuit stated.
Maureen Curran Kleinman, a spokeswoman for The Valley Hospital and its associated medical group — the place Jones and Kuo are employed — stated, “We won’t be commenting on this matter.”
Bergen Anesthesia Group, which employs Telfeyan, didn’t reply to requests for remark.
On Friday, Rep. Invoice Pascrell Jr., a Paterson Democrat, joined 11 different members of Congress in asking the U.S. comptroller basic to research how the facility morcellator was permitted by the federal Meals and Drug Administration within the first place, and what’s being achieved to ensure it’s protected sufficient to stay available on the market.
“The facility morcellator is just one of many medical units to boost critical considerations about security and efficacy,” stated Pascrell, who has pushed for improved monitoring of units and reporting of hostile occasions.
Ruscitto’s lawsuit contends that months earlier than her surgical procedure, the federal government suggested well being professionals concerning the hazard of spreading beforehand undetected most cancers when the gadget was used. Different strategies of doing the process have been out there, the lawsuit says, and her physician ought to have accomplished a biopsy earlier than choosing morcellation.
An estimated 600,000 hysterectomies are carried out a yr. The FDA first permitted energy morcellators in 1991, making it attainable for surgeons to do minimally invasive hysterectomies. Historically, the procedures have been carried out by way of an incision within the stomach or pubic space. With the system, surgeons promised a quicker, simpler restoration, with much less probability of an infection, and thought of the danger of spreading most cancers to be extraordinarily uncommon.
Lately the FDA revised its evaluation of the most cancers danger. It now says that one in each 350 ladies who undergoes a hysterectomy for fibroids has a most cancers that will not have been detected however could possibly be unfold by morcellation.
The high-speed, spinning blades of a morcellator reduce and shred tissue into smaller fragments that may be eliminated via small incisions. When it minces the tissue, some fragments could also be left behind, attaching to the intestines or the stomach wall, and even touring to different areas of the physique by means of blood vessels or lymph. If the tissue accommodates most cancers, the dispersed cells trigger the most cancers to unfold, or metastasize, and alter it from an early-stage most cancers to a a lot greater stage. Stage four leiomyosarcoma is taken into account incurable.
“Tons of, if not hundreds, of girls in America are lifeless” as a result of the system was used on them in a laparoscopic hysterectomy, the congressional contingent wrote in Friday’s letter. “This system can take a Stage 1 treatable most cancers instantly to a Stage four terminal most cancers. For too many ladies, this routine process ended with a demise sentence.”
In Ruscitto’s case, she was recognized with Stage four most cancers inside weeks of her operation.
The primary public consideration to potential issues with the system got here in December 2013, when a Boston anesthesiologist, Amy Reed, and her husband, a coronary heart surgeon, spoke about her battle with metastatic leiomyosarcoma in The Wall Road Journal. Their story, about her analysis following a routine hysterectomy carried out with an influence morcellator, appeared on the entrance web page. Reed’s husband, Hooman Noorchashm, began an internet petition at change.org to cease using energy morcellators in minimally invasive gynecologic surgical procedure. His one-man marketing campaign reached the FDA and federal lawmakers.
In April 2014 the FDA issued a “security communication” discouraging use of energy morcellators for uterine fibroids and informed well being care professionals to debate the dangers and advantages of the remedy with their sufferers. That month, Johnson & Johnson, the system’s largest producer, suspended gross sales of latest morcellators. Many well being techniques additionally suspended their use.
An FDA panel held two days of public hearings about morcellators in July 2014.
-
Without more monitoring, medical devices will keep harming patients
Aug 13, 2015 | Lexington Herald-Leader
By Kevin Kavanagh
A caller to Jack Pattie's radio show recently asked a disturbing question: Are patients guinea pigs for medical devices?
I responded that medical devices are often poorly tested and if I received a faulty one, guinea pig would be the mildest term I would use.
In fact, we are not even guinea pigs, we are sacrificial lambs for corporate profits.
When a guinea pig is used in an experiment, data are collected to improve the product. Not so with medical devices. There is little effective post-market monitoring of these devices.
Just look at the morcellation debacle. A device intended to grind tissue into little pieces, thus allowing hysterectomies to be performed through a small incision, was found after 20 years of use to be spreading cancer. High failure rates are being reported for metal-on-metal-hip implants which can even cause metal poisoning; retrograde medical endoscopes can spread untreatable bacteria. Safety problems are being reported for vaginal mesh, used in reconstructive surgery, and the Sprint Fidelis heart defibrillator.
These devices and others have been implanted in hundreds of thousands of people and have caused harm and death in untold numbers.
That's right, untold numbers. No one in the United States is effectively watching what happens to these devices after they are implanted in patients. The safety feedback loop, which helps spur device improvement and safeguards patients, is all but lacking.
The problems with metal-on-metal hip implants were first systematically detected in England, which has an effective reporting registry.
Problems with retrograde medical endoscopes spreading untreatable bacteria were known in Europe two years before the United States, and morcellators posed an unacceptable risk of spreading cancer for many years before anyone noticed.
Some have stated it is not practical to test all medical devices. This may be true, but I want any device implanted in me to be thoroughly tested.
The U.S. House of Representatives passed the 21st Century Cures Act but instead of strengthening medical device oversight, the House weakened the requirements for testing even further.
What are patients to do?
First, remember that for many implants the benefits are overestimated and the risks underestimated. Before any implant procedure patients should at least ask:
■ What is the implant's failure rate?
■ How does the tissue react around the implant?
■ If the implant fails can it be taken out?
I was faced with a decision once to have metal cervical joints placed at multiple levels in my neck. I asked the above three questions. The first two were not known and the answer to the third was no. I chose to have the "old-fashioned" cervical fusion.
Some would think that a device that has long been in use would be safe. But, as exemplified by the morcellator, which was first marketed in 1994, if no one monitors for problems they may be perpetuated indefinitely. Out of sight, out of mind.
Next, patients should check the MRSA and C. Difficile rates at their hospital, available on Hospital Compare (https://www.medicare.gov/hospitalcompare/).
If you are having a hip or knee implant or a lumbar or cervical spine fusion, check for your surgeon's complication rates on ProPublica's Surgeon Scorecare website(https://projects.propublica.org/surgeons/).
Finally, remember nothing lasts forever and all man-made devices can fail, so keep your follow-up appointments.
For those with chrome-cobalt metal hip implants, consider having blood cobalt levels tested to screen for dangerous, and sometimes life-threatening, heavy metal poisoning. Your doctor may tell you there is not good literature to support the testing. But remember few are looking for or monitoring problems.
Dr. Stephen Tower just reported in the Journal of Patient Safety 25 cases of cobalt poisoning from hip implants. Until the true incidence is known, play it safe and get tested.
According to a report from Johns Hopkins published in the Journal of Patient Safety, over half of all medical hospital inpatients had an implant. It is more likely than not that you are or will be an implant recipient.
Almost everyone has a stake in health-care policy regarding implants.
We all need to encourage Congress to amend the 21st Century Cures Act to assure effective pre-market testing and post-market monitoring of medical devices.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
Add recipients
Suggested