Vaginal Mesh Implants: Experimental! NICE

Vaginal mesh operations should be banned, says NICE

By Anna Collinson

Reporter, Victoria Derbyshire programme

• 27 November 2017  FiDA highlight
  

Draft guidelines from NICE say the implants should only be used for research - and not routine operations.

Some implants can cut into the vagina and women have been left in permanent pain, unable to walk, work or have sex.

One expert said it is highly likely the NHS will take up the recommendation.

However, the organisation is not compelled to act on findings it receives from NICE.

Both NHS England and NICE declined to comment.

'Life-changing consequences'

In the documents - to be published after consultation in December - NICE said there were "serious but well-recognised safety concerns" and that "evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity".

It added that "when complications occur, these can be serious and have life-changing consequences", but said "most commentaries received from patients reported satisfaction with the procedure".

One woman, Margie Maguire, 41 - told the Victoria Derbyshire programme she cannot have any more children or walk unaided because of the damage caused by the mesh.

"I have chronic pelvic pain on a daily basis and I'm on nine different medications when I have a pain attack.

"These can last from two to six hours at a time and is like having a heart attack," she said.

Kate Langley told the programme in April she had been admitted to hospital 53 times to try to end the pain, but - like many women - the mesh was so near the nerve it could not be fully removed.

She has been left with nerve damage and in permanent pain by the implants, giving up her business as a childminder because the pain was so intense.

The surgeon who first examined her, she explained, "could see the [mesh] tape had come through my vagina - protruding through"

The plastic meshes are made of polypropylene - the same material used to make certain drinks bottles - and manufactured by many different companies.

They are used to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.

The University of Oxford's Prof Carl Heneghan, an expert in the subject, said the draft guidelines were an admission that health services had "got this wrong" - calling the use of mesh a "catastrophe".

He described the draft guidelines as a "backdoor ban" on implants that would effectively end their use.

But he said it had come too late.

"Seven years I have been watching this emerge - it is absolutely farcical how bad it is. Either they're burying their heads in the sand or they don't know what they're doing."

He called for a registry to be created for everyone who had been treated with the implants so that their effects could be fully understood.

In April, the BBC learned more than 800 UK women are taking legal action against the NHS and the makers of vaginal mesh implants.

The NICE documents suggest "randomised controlled trial data showed no added benefit of using mesh compared with native tissue repair".

Between April 2007 and March 2015, more than 92,000 women had vaginal mesh implants in England, according to NHS data from the Hospital Episodes Statistics.

About one in 11 women has experienced problems, the data suggests.

The use of vaginal mesh to treat urinary incontinence is not mentioned in the draft NICE guidelines.

In Scotland, former Scottish Health Secretary Alex Neil requested a suspension of mesh implants by the NHS in 2014, but figures obtained by the BBC in December 2016 showed hundreds of operations have been performed since.

A number of Scottish health boards have stopped using mesh implants altogether.

The mesh is also used routinely in hernia repair despite concerns it is leaving many patients in chronic pain.

The Department of Health declined to comment.

Watch the Victoria Derbyshire programme on weekdays between 09:00 and 11:00 on BBC Two and the BBC News Channel.

http://www.bbc.com/news/health-42110076

J&J Sold Pelvic Mesh While Concealing Risks: Washington State Attorney General

• AG FILES MAJOR LAWSUIT AGAINST JOHNSON & JOHNSON OVER CONCEALED RISKS OF PELVIC MESH

• FOR IMMEDIATE RELEASE: 

May 24 2016  FiDA highlight

Complications left women permanently disabled, in chronic pain

SEATTLE — Attorney General Bob Ferguson filed a consumer protection lawsuit today against Johnson & Johnson, accusing the company of knowingly concealing the risks associated with a surgical mesh designed to treat pelvic floor conditions in women. As a result of Johnson & Johnson’s deception, thousands of Washington women face urinary and defecatory dysfunction, loss of sexual function, chronic inflammation, chronic pain, and risk of chronic infection.

These complications can crop up years after the surgery, and are in many cases irreversible. Removal of the mesh is nearly impossible.

“It’s difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson & Johnson’s deception,” Ferguson said. “They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials. This is an unacceptable way of doing business, and I will hold the company accountable.”

The lawsuit alleges thousands of violations of the Washington Consumer Protection Act, due to deceptive informational and marketing materials distributed to consumers and doctors. The attorney general will ask the court to prohibit Johnson & Johnson’s misleading marketing, find the company violated the CPA, and impose the maximum $2,000 civil penalty per violation, in addition to costs, fees and restitution.

The state alleges tens of thousands of violations of the CPA, potentially placing penalties well into the millions of dollars.

Johnson & Johnson is the largest manufacturer and seller of these mesh devices in the U.S. Between 2005 and 2015, the company sold nearly 12,000 mesh devices in Washington.

The mesh is made of woven polypropylene threads, and is marketed to doctors and patients as a way to treat pelvic organ prolapse, or when organs shift from their normal position, and various bladder issues.

The mesh is inserted surgically, and is put into place by pulling it up through the vaginal canal, then through an incision in the vaginal wall, and finally permanently anchoring it in the body to hold up falling organs.

The mesh, its construction and infection-ridden insertion through the vagina have caused chronic infection, chronic inflammation, permanent loss of sexual function, and permanent urinary or defecatory dysfunction. The mesh can shift position and cut through the vaginal wall or into other organs.

One patient shared this about her ordeal:

“I experienced excruciating pain from day one. I felt as though my urethra was being strangled, I couldn’t pee, walking was out of the question, sitting was agony, & I couldn’t lie on my left side due to severe pain and numbness at my left groin area.  Over the course of the next 14 weeks I visited/was admitted to the [hospital] 10 times. … I had no quality of life.  My consultant likened the mesh removal as to ‘trying to remove chewing gum from hair.’  … I still suffer left side groin pain and numbness, buttock pain, sharp pains in my lower stomach and I am less continent now than I was pre-op.” 

A doctor described in a 2009 email to Johnson & Johnson: “I am currently getting a patient to the OR who had an anterior and posterior prolift implanted by another physician.  She will likely lose any coital function as her vaginal length is now 3cm, and there is mesh extruding literally everywhere. … This patient will have a permanently destroyed vagina.”  

The company never told consumers that the mesh can cause, and consumers are likely to experience, chronic foreign body reaction and chronic inflammation as the body constantly fights to rid itself of this foreign material.

The company never told consumers that mesh causes and harbors infection, which can indefinitely live in the small weaves of mesh.

The company never told consumers that severe erosion — or a complication where the mesh moves and protrudes into an organ or through the vaginal wall — causing chronic pain and dyspareunia, or painful intercourse, is a common complication.

One patient said, “[I] had all kinds of problems with chronic pain, bleeding, dyspareunia (even my husband complained of scraping and poking)…The pelvic pain was keeping me awake at night, and the only relief was to sit on a tennis ball. The thought living like that, sitting on a ball, wearing a diaper, splinting my perineum to have a bowel movement, having infrequent and miserable sex, and marital problems was almost more than I could bear.”

And the company never told consumers that this risk of erosion is lifelong, because the implant is permanent, or that erosion can cause chronic pain and injury to sexual partners.

Women who have Johnson & Johnson mesh devices and are experiencing symptoms can contact investigator MaryBeth Haggerty Shaw at MarybethH@atg.wa.gov or contact our Consumer Resource Center at 1-800-551-4636. Complaints can be filed at atg.wa.gov/file-complaint.

This case is being handled by Senior Counsel Lisa Erwin, Assistant Attorneys General Andrea Alegrett and Leilani Fisher. The case has been filed in King County Superior Court.

-30-

The Office of the Attorney General is the chief legal office for the state of Washington with attorneys and staff in 27 divisions across the state providing legal services to roughly 200 state agencies, boards and commissions. Attorney General Bob Ferguson is working hard to protect consumers and seniors against fraud, keep our communities safe, protect our environment and stand up for our veterans. Visit www.atg.wa.gov to learn more.

- See more at: http://www.atg.wa.gov/news/news-releases/ag-files-major-lawsuit-against-johnson-johnson-over-concealed-risks-pelvic-mesh#sthash.V0tz1X8g.Myhh7sWx.dpuf

http://www.atg.wa.gov/news/news-releases/ag-files-major-lawsuit-against-johnson-johnson-over-concealed-risks-pelvic-mesh

Peter Lavallee, Communications Director, (360) 586-0725; PeterL@atg.wa.gov

J&J Medical Devices Cut 6% of Staff: No Mention of Patient Harm/Pending Lawsuits

Johnson & Johnson to cut about 3,000 jobs in medical devices

JANUARY 19, 2016 3:04 PM

BY MATTHEW PERRONE AND TOM MURPHY

AP Business Writers

Johnson & Johnson said Tuesday that it plans to cut about 3,000 jobs over the next two years as the health care conglomerate works to restructure its medical devices business.

The New Brunswick, New Jersey, company said that amounts to more than 2 percent of its global workforce of around 127,000 people and 4 percent to 6 percent of its employee total in medical devices.

The cuts come after a tough year for the healthcare bellwether, which has seen sales of its prescription drugs, devices and consumer medicines squeezed by a weakening global economy and unfavorable currency exchange rates.

"These actions recognize the changing needs of the global medical device market," said Gary Pruden, chairman of Johnson & Johnson's medical device unit, in a statement.

The restructuring focuses on the company's orthopedics, surgery and cardiovascular businesses. It won't affect consumer medical devices, pharmaceuticals or consumer businesses.

J&J has struggled to revive sales of medical devices, particularly brands like DePuy orthopedic implants and Ethicon surgical equipment. In October the company said device sales dropped 7.3 percent to $6.1 billion in the previous fiscal quarter. In the same month, J&J sold its Cordis heart devices unit, which previously accounted for about one-quarter of device sales.

Wells Fargo analyst Lawrence Biegelsen noted that medical devices have been "one of the weaker performing businesses in recent years."

"As such, we believe that the restructuring should be a positive step towards driving longer term growth of the business and enhance profitability over time," Biegelsen said in a note to investors.

The company's actions will lead to annual pre-tax savings of $800 million to $1 billion, much of which will be realized by the end of 2018. J&J said it will consider "strategic options" for underperforming business units.

J&J will book a fourth-quarter charge of about $600 million in connection with the restructuring.

Leerink Swann analyst Danielle Antalffy said Tuesday's announcement increases the likelihood of an acquisition to boost the company's medical device prospects. She notes J&J has roughly $37 billion in cash.

Citing conversations with J&J executives, Antalffy states "it's clear to us that it's a matter of when, not if J&J does a deal."

J&J shares rose 4 cents to $97.04 in trading Tuesday. Its shares have fallen more than 6 percent over the past year.

Read more here: http://www.kentucky.com/living/health-and-medicine/article55408700.html#storylink=cpy

Must watch video: Dr. Amy Reed and Dr. Hooman Noorchashm

https://www.youtube.com/watch?v=o_nUk1MQa2c&feature=youtu.be

Criminal?: Scottish Surgical Mesh Scandal

Revealed: Two doctors on mesh safetyreview team linked to makers of controversial devices

         Oct 05, 2014 13:53

         By Marion Scott  Daily Record (UK)  FiDA highlight

HEALTH Secretary Alex Neil under fire after victims claim the government probe into mesh implants is being rigged to give operations the all-clear.

Health Secretary Alex Neil

TWO doctors on the government team reviewing the safety of mesh implants have links to the makers of devices used in the controversial surgery.

The appointments have fuelled concern of campaigners that the review has been weighted to support the continued use of the procedures, which have left women around the world crippled and led to multi-million-pound compensation payments.

Ash Monga and Karen Guerrero have been paid by Ethicon, the makers of a mesh product called Gynecare.

Dr Monga described himself as a “consultant for Gynecare” in a 2009 medical research paper.

Dr Guerrero, a surgeon at Glasgow’s Victoria Infirmary, received “educational sponsorships” – including payments and travel costs – from Ethicon and another major mesh manufacturer called Bard.

Dr Karen Guerrero

Both were appointed to a 22-strong safety review commission investigating mesh products launched by Health Secretary Alex Neil.

He won plaudits in June after apparently suspending mesh procedures when Hear Our Voice campaigners, supported by the Sunday Mail, gave evidence to reveal how they have been left in crippling agony by mesh, used to treat prolapse and bladder problems.

At the time, Neil said: “I’m proud Scotland has taken this stance and I believe we are leading the way on what is a significant global problem.”

But we revealed the anger of campaigners last week after discovering government medical advisers wrote to hospitals within weeks of Neil’s announcement to say the suspension was voluntary and encouraged them to use mesh on patients as part of clinical trials.

Yesterday, politicians and campaigners raised new concerns about the appointments to the review body to establish if there are any conflicts of interest.

Scottish Labour’s shadow health secretary Neil Findlay said: “It is outrageous that, after taking over a year to reach a decision on mesh implants, the Health Secretary has appointed doctors to the review who might appear to have a vested interest.

“Those affected have been through far too much in the past few years and this latest development is simply inexcusable.”

Mesh product

Olive McIlroy, of Scottish Mesh Survivors, said: “We are dismayed that people appointed to carry out this vital review have such links to the manufacturers who profit from the use of these devices.

“Alex Neil promised victims would be at the very heart of the independent review but it feels very much like we are lone voices pitted against the country’s most powerful mesh supporters.”

Ethicon, a subsidiary of Johnson & Johnson, have twice had their TVT-O device declared as “defective” by a US court.

It has also emerged that Gibraltar-born Guerrero was among 23 signatories backing an objection to Neil’s suspension of mesh use in the NHS in June.

Dr Guerrero backed the call made by Aberdeen-based urology consultant Mohamed Abdel-Fattah asking for mesh trials to be exempted.

Abdel-Fattah, who has also received “travel sponsorship” from Ethicon, was supported by two other members of the review group, Professor Charis Glazener and consultant urologist Voula Granitsiotis.

Read about US mesh victim Martha Salazar who won a £60m payout.

Ethicon’s Lucinda Macari said: “Ethicon, in conjunction with the Association of British Healthcare Industries, are supporting efforts by the Scottish Independent Review to gather full and accurate information about pelvic mesh products.”

The Scottish Government said: “This must be an entirely independent review and will be completed as such.”

          

Mesh scandal: Another boost forScottish campaigners as US victim wins £60m payout

         Sep 14, 2014 14:11

         By Marion Scott  Daily Record (UK)

MARTHA Salazar's case in Dallas, Texas – the second major victory for mesh victims in America within days – prompts new calls for criminal inquiry in Scotland.

Campaigner Elaine Holmes in the Scottish Parliament.

AN American mesh patient has been awarded £60million compensation by a US court.

Martha Salazar won the huge payout after the court in Dallas, Texas, heard that the Obtryx implant made by Boston Scientific was defective.

They jury was also told that the manufacturers had failed to properly test the device on humans.

It was the second major victory for mesh victims in the States within days.

Earlier this month, Jo Huskey was awarded damages totalling £3million by a West Virginia court for pain and suffering caused by a TVT-O mesh 
implant made by Johnson & Johnson firm Ethicon.

Both these mesh devices were given to Scottish women on the NHS before the procedures were suspended pending safety reviews after an outcry by mesh victims.

The US payouts have led to politicians and victims calling for the Scottish Government to sue manufacturers and launch a criminal probe.

Labour’s shadow health secretary Neil Findlay said: “These cases are proof, if any further evidence is needed given the hundreds of women injured here, that the mesh scandal is shaping up to be a very big issue for Scotland’s NHS.

“It’s high time the Scottish Government challenged the manufacturers over the catastrophic health problems these devices have inflicted on so many women.

“If there’s evidence of clinic data and trial evidence being deliberately withheld, criminal action should be considered.”

Elaine Holmes, of Scottish Mesh Survivors, added: “A car manufacturer who did this would face a criminal investigation and lengthy jail sentences. It should be the same for mesh manufacturers.”

Lawyer Cameron Fyfe, who is acting for over 400 women involved in the biggest-ever medical legal action in Scotland, said: “Potential damages in 
Scotland would be a fraction of those in the US but we expect to have similar success.”

Gareth Easton

Scottish Health Secretary Alex Neil

Health Secretary Alex Neil suspended mesh operations in March pending an independent safety review.

It followed a Sunday Mail campaign which exposed the hidden agony of hundreds of women given mesh implants to treat incontinence and bladder problems.

Please Sign this Change.org Petition to Restrict Uterine Power Morcellation

PLEASE SIGN THIS PETITION TO BAN UTERINE POWER MORCELLATION

FDA hearing July 10 & 11 (deadline)

A Surgical Procedure’s Risks,Unmentioned

By JANE E. BRODY MARCH 17, 2014 12:01 AM

PERSONAL HEALTH

Jane Brody on health and aging.

Many patients assume that, like prescription drugs, surgical procedures and instruments undergo extensive testing and must be government-approved. It’s not necessarily so.

Developers, of course, do test new instruments, and practitioners often train with an expert before using them unsupervised to treat patients. And the Food and Drug Administration must confirm an instrument’s safety and effectiveness before it can be marketed — but only if the device is deemed significantly different from others already approved.

Surgical techniques, however, are not subject to the stringent approval process that drugs go through. And as with drugs, problems with new procedures may not become apparent until after they have been used many hundreds or thousands of times.

Such is the case with a popular treatment for a very common medical problem: uterine fibroids. The technique, called electric or power morcellation, has widespread appeal for both surgeons and patients. It is used during laparoscopic or robotic-assisted operations that are fast and effective, require only a tiny incision or none at all, and involve less pain, a shorter hospital stay and a quicker recovery. In most cases, these operations are safer than traditional surgery.

As recent reports have shown, however, power morcellation can also cause serious and sometimes life-threatening complications. Experts say that prospective patients are often not told about these risks before consenting to the operation.

The technique involves insertion of a tiny instrument with a rapidly rotating blade, the morcellator, that breaks up the fibroid so that it can be sucked out through the small opening of a laparoscope. But problems can arise months or years later if pieces of tissue escape into the pelvic cavity and seed themselves on other organs.

This problem is all the more serious if the fibroid that was morcellated happens to have contained a hidden cancer. Although the overwhelming majority of fibroids are benign, there is no certain way to tell before their removal if they harbor a cancer, which happens in 1 in 400 to 1 in 1,000 cases.

One such case involves a 41-year-old Bostonian, Dr. Amy J. Reed, an anesthesiologist and a mother of six, who now has a Stage 4 leiomyosarcoma after undergoing uterine morcellation. It is a rare but particularly aggressive uterine cancer. Dr. Reed and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are waging a campaign through Change.org to halt use of the technique.

Despite several preoperative tests, neither Dr. Reed nor her surgeon suspected that cancer lurked within the fibroids that were removed. If she had had a traditional operation in which the fibroids were cut out or the entire uterus removed intact, it is highly unlikely that the cancer would have spread.

From 1983 through 2010, 13 unexpected uterine sarcomas were reported after uterine surgery on 5,666 patients. Among 1,192 women who underwent morcellation, two developed sarcoma that spread within the abdomen.

After reviewing the medical records of more than 1,000 women who received morcellation for fibroids, specialists at Brigham & Women’s Hospital in Boston found a ninefold higher rate of unexpected sarcoma than is now quoted to patients considering the procedure.

“These data suggest uterine morcellation carries a risk of disseminating unexpected malignancy with apparent associated risk of mortality much higher than appreciated currently,” the researchers wrote in the journal PLOS One in 2012.

Even benign uterine tissue, when it is spread to other parts of the abdomen during morcellation, can grow in places it doesn’t belong and cause pain, infection or bowel obstruction.

There is a technique that could make morcellation safer: encasing the tissue to be removed in a bag before it is broken up. But thus far, the procedure is infrequently used, and few surgeons are skilled in the technique.

Other established ways to treat bothersome fibroids are free of this potential risk, though complications like wound infection are possible.

Fibroids are extremely common, affecting half or more women during their reproductive years, when hormones foster their growth. They develop from the smooth muscle tissue of the uterus, ranging in size from tiny to huge, and often shrink after pregnancy and menopause.

Most women with fibroids are unaware they have them, but others can experience symptoms like prolonged heavy periods, bleeding between periods, pelvic pressure, constipation, frequent urination, backaches and anemia. They can sometimes cause infertility or miscarriage.

Fibroids are typically detected through a pelvic exam, sonogram or M.R.I., sometimes with saline solution or a dye used to better define their size and location.

Nothing needs to be done about a fibroid that causes no distress. Large, bothersome fibroids can often be shrunk by several months of treatment with medications that block estrogen and progesterone, causing temporary menopause and its attendant symptoms.

The drug mifepristone (RU-486) also can shrink fibroids, and Evista may do likewise, but only in postmenopausal women. Sometimes a low-dose oral contraceptive is used to reduce bleeding caused by fibroids without shrinking their size.

Noninvasive ultrasound surgery under M.R.I. guidance can be used to heat and destroy a fibroid without damaging the uterus. A fibroid also can be destroyed by injecting small particles into uterine arteries to cut off its blood supply.

Fibroids can be removed laparoscopically or robotically without damaging the uterus. If the fibroid is contained within the uterus, it can often be removed with surgical instruments inserted through the vagina and cervix. Some fibroids may be destroyed by applying heat or electric current to the uterine lining.

Very large, multiple or deep fibroids may require more traditional surgery, called an abdominal myomectomy, that spares the uterus, or with a hysterectomy, a more serious operation involving removal of the entire uterus, ending a woman’s menstrual periods and ability to bear children.

If you are contemplating treatment for symptomatic fibroids, your doctor should answer several important questions before you choose a method:

What is the nature of the problem, and how necessary is it to treat it?

What procedures are known to be effective, and what are the risks and benefits of each?

What is the approach you recommend, and how much experience do you have with it?

What are its possible complications, and how often do they occur?

Without a clear understanding of treatment options, their potential hazards as well as their effectiveness, it is not possible to for you to give informed consent.

http://en.wikipedia.org/wiki/Morcellator

Morcellator

From Wikipedia, the free encyclopedia

Jump to: navigation, search

A morcellator is a surgical instrument used for division ("morcellation") and removal of large masses of tissues during laparoscopic surgery.[1] It can consist of a hollow cylinder that penetrates the abdominal wall, ending with sharp edges[1] or cutting jaws,[2] through which a grasper can be inserted to pull the mass into the cylinder to cut out an extractable piece.[1][2]

Morcellation devices in surgery[edit]

Laparoscopic morcellation is commonly used at surgery to remove bulky specimens from the abdomen using minimally invasive techniques. Historically, morcellation was performed using a device that required the surgeon or assistant to manually 'squeeze' the handle. Other reports describe using a scalpel directly through the abdomen to create small specimens that can be drawn out of the abdominal cavity. In 1993, the first electric morcellator was introduced in the US market. It was initially used for uterine extraction, but later applied to other organs. The use of morcellators at surgery has now become commonplace, with at least 5 devices currently on the US market. Despite decades of experience, there remains limited understanding of the short-term and long-term sequelae of morcellation. Concerns have been raised about injury to surrounding organs including bowel, bladder, ureters, pancreas, spleen and major vascular structures. Long-term issues may include parasitic growth of retained tissue with the potential to cause adhesions, cause bowel dysfunction and potentially disseminate unrecognized cancer.

Safety concerns of morcellation devices in gynecologic surgery[edit]

Morcellation is associated with spreading of cellular material of the morcellated tissue. In gynecologic surgery for benign pathologies there is approximately a 0.09% risk of an unexpected leiomyosarcoma. After morcellation 64% of such cases may develop disseminated disease which is of particular concern because of the considerable mortality of leiomyosarcoma. Morcellation of the more frequent benign leiomyoma variants may also cause disseminated disease, which while not associated with increased mortality is frequently inoperable and therefore more difficult to manage than the original disease.[3][4]

On April 17, 2014 the Food and Drug Administration issued a warning that morcellators may spread occult cancer in the course of fibroid removal.[5] Johnson & Johnson subsequently suspended sale of its morcellators until the role of morcellation "is redefined by the FDA and the medical community."[5]

See also[edit]

•                Instruments used in general surgery

References[edit]

1.             ^ Jump up to: 
a b c Disposable laparoscopic morcellator, GM Savage, JJ Christian, DC Dillow - US Patent 6,039,748, 2000

2.             ^ Jump up to: 
a b Morcellator, Jude S. Sauer, Roger J. Greenwald, Mark A. Bovard, John F. Hammond - US Patent 5562694. Issue date: Oct 8, 1996.

3.             Jump up 
^ Seidman, M. A.; Oduyebo, T.; Muto, M. G.; Crum, C. P.; Nucci, M. R.; Quade, B. J. (2012). "Peritoneal Dissemination Complicating Morcellation of Uterine Mesenchymal Neoplasms". In Sullivan, David J. PLoS ONE 7 (11): e50058. doi:10.1371/journal.pone.0050058. PMC 3506532. PMID 23189178. edit

4.             Jump up 
^ Cucinella, G.; Granese, R.; Calagna, G.; Somigliana, E.; Perino, A. (2011). "Parasitic myomas after laparoscopic surgery: An emerging complication in the use of morcellator? Description of four cases". Fertility and Sterility 96 (2): e90–e96. doi:10.1016/j.fertnstert.2011.05.095. PMID 21719004. edit

^ Jump up to: 
a b Robert Lowes (April 30, 2014). "J&J Suspends Power Morcellator Sales Over Cancer Risk". Medscape. Retrieved April 30, 2014.