Preview Newsletter
Ethicon Media Monitoring 3/30/2018
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Don’t book a bouncy castle for my birthday party, you’re not a fun mum any more. Six year old sums up the mesh implant disaster.
Mar 29, 2018 | Cambs Time
By Kath Sansom
The call comes as women prepare for the next round in their fight to get mesh operations banned with a major debate in the main chamber of the House of Commons on April 19. -
Benefits/risks of pelvic mesh addressed in C.R. Bard trial taking place in New Jersey
Mar 30, 2018 | Legal News Line
By John Sammon |
The trial over a woman’s allegations against a medical manufacturer over a mesh implant device that allegedly caused her intense pain and physical damage on March 27 focused on the perceived risks and benefits of the device. -
Rotting Pelvis: Australian Senate bans transvaginal mesh implant after investigating potential serious side-effects
Mar 29, 2018 | Catch News
Australia is facing one of the biggest medical scandals ever. There are reports that 10,000 to 15,000 people are facing serious side effects after receiving transvaginal mesh implants. -
These Women Suffering Complications From Mesh Implants Were Let Down By The Health System, Inquiry Says
Mar 29, 2018 | Buzzfeed News
By Gina Rushton
Thousands of Australian women suffering "devastating complications" from transvaginal mesh implants have been "ignored" and "let down" by health professionals and regulatory bodies, and the surgery should only be performed as a "last resort", a Senate inquiry into the devices has concluded. -
New Zealand doctors are arguing for the continued use of surgical mesh for some procedures after an Australian Senate committee inquiry said it should only be used as a last resort.
Mar 29, 2018 | Stuff
By Cate Broughton
A Kiwi woman who spent $40,000 to have a United States surgeon remove her surgical mesh says New Zealand should follow the just-released recommendations from an Australian Senate inquiry. -
Australian Senate Issues Report On Issues Surrounding Vaginal Mesh
Mar 30, 2018 | Immortal News
By Zye Angiwan
The report also noted that there has been considerable concern regarding whether or not health professionals had informed patients of the possible side effects of using these devices. -
NZ doctors argue for some uses for mesh
Mar 30, 2018 | NZ City
New Zealand doctors are arguing for the continued use of surgical mesh for some procedures after an Australian Senate committee inquiry said it should only be used as a last resort.
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Mar 29, 2018 | Cambs Time
By Kath Sansom
The call comes as women prepare for the next round in their fight to get mesh operations banned with a major debate in the main chamber of the House of Commons on April 19.
Sling The Mesh, whose membership has increased six fold since last year - from 1,000 up to 5,880 members - said the only way to uncover the scale of the disaster is to write to every woman given an incontinence or prolapse repair using mesh tapes, slings or patches in the last 20 years.
Julie Gilsennan, a spokesman for Sling the Mesh, said: “The shattered lives, pain and suffering is wrong on every level. I’ve gone from super fit paramedic to now in the ambulance call centre as I can’t do that job any more.
“My six year old son said to me, mum please don’t book a bouncy castle for my birthday this year because you’re not a fun mum any more.
“That’s the reality of mesh when it goes wrong.”
The campaign, launched by our newspaper in 2015, has received its latest supporter, thanks to local Peterborough MP Fiona Onasanya, who said: “Given that mesh can shrink, degrade or twist in a woman’s body, can I ask the prime minister if she will support proposals to sling the mesh?”
And she paid tribute to local journalists who have drawn attention to the campaign adding “Journalist Kath Sansom and editor John Elworthy have played a huge part in highlighting the dangers of vaginal mesh.”
The debate in the House of Commons chamber will be led by MP Emma Hardy.
Owen Smith, chairman of the All Party Parliamentary Group into mesh implants, will be able to speak, now that he is no longer a front bench member of the Labour Party after Jeremy Corbyn removed him over his calls for another Brexit refeerndum.
Behind the scenes, insurers are closely watching the scandal unfold to determine if it will affect premiums for private patients under going surgery or for companies who insure surgeons.
A Vitality spokesman said: “We are aware of the risk of surgery involving meshes, and we have additional measures in place for vaginal procedures to ensure the surgeon has discussed the risks with the customer prior to implantation.
“We are aware of the media reports about some patients having complications. We are closely monitoring the situation and providing advice to members where needed.”
An Aviva spokesman said: “Surgical mesh has been available for a long time and is well established in the treatment of hernias. Its use in prolapse and incontinence treatment is more recent and recent reviews have shown that there are concerns over both its safety and effectiveness.
“The final determination of the potential liability of the mesh as a product is yet to be determined. As we provide cover for subsequent procedures then yes we do understand that there is a risk for additional cost to help customers with problems.
“We are closely watching the development of legal claims and will consider action in relation to these as matters become clearer.”
An LV spokesman said: “While mesh implants themselves would not impact on premiums for life or critical illness insurance, it’s possible that the underlying medical condition itself and any on-going symptoms could affect whether we are able to offer insurance or the price of the policy.”
A Zurich spokesperson said: “We do not consider mesh implants to be an increased risk for customers applying for our protection products,” however they added: “If a mesh implant has resulted in complications, or caused a disability or inability to work, then we would assess the severity of this, and how it might increase the risk of long-term disability or reduce life expectancy, as we would with any other factors which may affect a customer’s health.”
http://www.cambstimes.co.uk/news/don-t-book-a-bouncy-castle-for-my-birthday-party-you-re-not-a-fun-mum-any-more-six-year-old-sums-up-the-mesh-implant-disaster-1-5457283
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Benefits/risks of pelvic mesh addressed in C.R. Bard trial taking place in New Jersey
Mar 30, 2018 | Legal News Line
By John Sammon |
The trial over a woman’s allegations against a medical manufacturer over a mesh implant device that allegedly caused her intense pain and physical damage on March 27 focused on the perceived risks and benefits of the device.
Mary McGinnis of North Carolina had Avaulta, a device with tentacle-like arms made of polypropylene, implanted into her pelvic region in March 2009 to treat bladder issues.
McGinnis later sued New Jersey-based C.R. Bard contending the company sold its Avaulta product to patients knowing the implant device was risky and that proper prior clinical studies and backup data were lacking.
Streaming video coverage of the trial at the New Jersey Superior Court in Bergen County was provided to Legal Newsline by Courtroom View Network.
C.R. Bard defense attorney Lori Cohen of the Miami law firm of Greenberg Traurig LLP asked witness for the plaintiff Dr. Anne Weber if any surgery to the pelvic region involved a risk of dyspareunia (painful intercourse), one of the conditions allegedly suffered by McGinnis.
“Yes,” Weber, a noted gynecological author and teacher, agreed.
“Any time there is surgery, there is a risk of permanent dyspareunia?” Cohen asked.
“No, I don’t agree with that,” Weber responded.
McGinnis' allegations include that the polypropylene mesh inflamed the tissue and that the device was too large, causing body erosion and contraction that resulted in the formation of scar tissue.
“It’s the tissue-mesh combination, it’s the foreign body reaction,” Weber explained. “It’s the inflammation working on the mesh fibers to contract (the implant).”
“Do you agree that mesh contraction does not always negatively impact the patient?” Cohen asked.
“No, I don’t agree with that,” Weber said.
Cohen asked Weber if the spine and hip pain reported by McGinnis were conditions with options for treatment to alleviate the pain.
Weber responded that a part of McGinnis’ hip complaints were related to the fact the mesh implant altered the sets of muscles on both sides of the body, or the trans-optimum frame muscles, which are used to walk.
“The damage that has been done there is irreparable,” Weber said. “Arthritis is treatable. The damage from the mesh is not.”
However, Cohen got agreement from Weber that McGinnis also suffered from degenerative disc disease.
“To a mild degree,” Weber told Cohen.
Weber also agreed with Cohen’s assertion she was not an expert at interpreting X-rays of spinal conditions.
Attorney for McGinnis, Adam Slater of Mazie, Slater, Katz & Freeman in Roseland, New Jersey, during cross-examination asked Weber if by using the Avaulta product, the benefits outweighed the risks and met acceptable standards.
“No,” Weber answered.
“Did clinical (product) data meet standards?” Slater asked.
“No, quite the opposite,” Weber answered.
Under further questioning, Weber testified that for the perceived benefit to balance risk, the use of Avaulta should have been limited to women with the most severe cases of prolapse and recurrent prolapse. She said McGinnis did not have a severe enough condition.
“Only then would the benefit favor using something like Avaulta, and that’s not Mary McGinnis,” Weber said.
“What happens with a mesh contraction?” Slater asked.
“An interaction between the mesh and tissue in which the tissue is encased in collagen that becomes a rigid scar plate,” Weber said. “It causes the mesh to become smaller in size than when it went in.”
Weber answered no to both questions if the more-traditional method of using sutures to treat prolapse would have caused tissue damage like mesh allegedly did, or be as difficult as mesh to remove.
During further testimony, Dr. Shlomo Raz, a noted pelvic reconstructive surgery physician who had surgically removed pieces of mesh from McGinnis in 2016, told the courtroom he once used mesh implants he cut himself but not devices like Avaulta, which he said come in kit form. He added he had abandoned the use of mesh approximately four years before.
“I abandoned mesh after seeing complications in the long run,” he said.
Raz disputed a 2014 American Urogynecologic Society report touting mesh as improving the quality of life for millions of women.
“The same people would now say mesh results are not better than what we had done before,” Raz said.
The trial continues with Judge James DeLuca presiding.
https://legalnewsline.com/stories/511372053-benefits-risks-of-pelvic-mesh-addressed-in-c-r-bard-trial-taking-place-in-new-jersey
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Mar 29, 2018 | Catch News
Australia is facing one of the biggest medical scandals ever. There are reports that 10,000 to 15,000 people are facing serious side effects after receiving transvaginal mesh implants.
For all those who do not know what is Transvaginal mesh- This is a net-like implant used to treat pelvic organ prolapse and stress urinary incontinence in women.
While the net was implanted to fix the problem but the aftermath was life-threatening. One of the patients who underwent this treatment shared that after the treatment was done, she immediately felt that she wasn't able to move her right leg and after a couple of days she felt as if a knife was constantly cutting her from inside.
This wasn't the only case, in past hundreds of women experienced a similar problem and filed a petition to the Australian Senate to ban the outdated procedure.
On Wednesday after a year of investigation into the matter, the Senate found that the medical practitioners did consider that there can be a side-effect. They did not think of alternative treatment options either.
The report released by the Senate stated that there should be improved treatment guidelines and medical training. Senate also highlighted that there is concern that there isn't a possibility to identify women who underwent this treatment.
Last year after hearing stories of over hundred women like Schulz, Senator Derryn Hinch started an inquiry in this matter. Many interviews of both patients and mesh manufacturers were conducted extensively.
While introducing the report, Hinch said that she hopes the report might satisfy petitioners and convince them that they have been heard of
.A GLOBAL ISSUE
This treatment has been controversial. There has been a lot of complain regarding this treatment from US, UK and Australia. As per National Health Service in UK, there has been more than 100,000 treatment across the country over two decades. There are 3% to 5% complications recorded.
http://www.catchnews.com/international-news/rotting-pelvis-australian-senate-bans-transvaginal-mesh-implant-after-investigating-potential-serious-side-effects-105422.html
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Mar 29, 2018 | Buzzfeed News
By Gina Rushton
Thousands of Australian women suffering "devastating complications" from transvaginal mesh implants have been "ignored" and "let down" by health professionals and regulatory bodies, and the surgery should only be performed as a "last resort", a Senate inquiry into the devices has concluded.
“The committee is deeply concerned by the accounts it has received of women’s experiences at the hands of medical practitioners,” the inquiry, which has been running since July last year, reported on Wednesday night.
“Even allowing for the positive accounts provided to the committee and the fact that some accounts are recalling events of over 10 or 15 years ago, they present the medical profession in a very poor light.”
Surgeons must obtain “informed consent” from patients receiving transvaginal mesh implants and medical regulators must record adverse side effects properly, the inquiry wrote in its 13 recommendations.
Urogynaecological meshes, sometimes known as transvaginal meshes, are inserted into women as a treatment option for pelvic organ prolapse (when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth), or urinary incontinence.
The inquiry estimated about 150,000 women in Australia have undergone transvaginal mesh procedures.
The underreporting of adverse events associated with transvaginal mesh products had provided a “false indication of the safety” of the devices, the report said.
There were more than 150 patient submissions made to the inquiry, the most heartbreaking of which you can read here, and almost all of them claimed there was no informed consent or awareness of the possible complications.
Almost every submission details a complication after the mesh was inserted.
These include: chronic and constant vaginal pain, visceral pain with bowel movements, dyspareunia (pain during sex), vaginal bleeding, inability to sit for more than an hour at a time, the granulation of vaginal tissue, pain through the glutes, inflammatory reactions, "offensive discharge", incontinence, leg weakness, and haemorrhages.
Dozens of women described "erosions" — when the product enters surrounding tissue, protrudes out of a body structure or tissue and into surrounding organs, causing holes or even haemorrhaging.
One woman had more than 12 operations to treat erosions and attempt to remove parts of her implant that were threatening to puncture surrounding organs.
“Many women who have had transvaginal mesh implants have had devastating complications resulting in ongoing emotional trauma, embarrassment, shame, depression, debilitating pain, recurring infection and a poor quality of life," the report said.
“The inquiry heard from many women who are living with the consequences of having had these implants. It is heartbreaking that for so long the experiences of these women have been ignored. These women have been let down, the system has failed them."
Women who couldn't have vaginal sex due to ongoing sexual dysfunction from urogynaecological mesh "repeatedly" reported their doctors suggested having anal sex instead, the Senate inquiry heard in August.
Half of the women who experienced adverse physical and psychological side effects after receiving a vaginal mesh implant have also suffered from a relationship breakdown after the procedure, the inquiry also heard.
The committee heard from doctors, hospitals and device manufacturers, including Johnson & Johnson, which in January withdrew from the market the controversial devices at the centre of a class action against it.
After nine months of consultations and hundreds of submissions the inquiry released the following 13 recommendations:
1. The Australian government, in consultation with the states and territories and the Medical Board of Australia, should review the current system of reporting adverse events to the Therapeutic Goods Administration (TGA) to implement mandatory reporting of adverse events by medical practitioners.
2. The TGA should develop a fact sheet for recipients of the devices to provide guidance on what to do (where to be treated and how to report it) in the event of an adverse event.
3. The Australian government should consider establishing a registry for all high-risk implantable devices.
4. The Medicare Benefits Schedule should release the report of the Gynaecology Clinical Committee (which recommended restricting the use of mesh to patients who are undergoing revision surgery) for consultation. Revision surgery refers to when a patient needs to have another operation to try to address the adverse impacts of the initial mesh insertion.
5. The Australian government should establish a better post-market monitoring scheme.
6. The Australian Commission on Safety and Quality in Health Care (ACSQHC) should prepare material on "informed consent" processes which would clarify the rationale for the proposed treatment and discuss potential complications as well as risks and benefits.
7. Treatment guidelines should clearly indicate that transvaginal mesh implantation should only be undertaken with fully informed consent and as a "last resort".
8. Medical professional specialist colleges and societies should make sure their members have access to resources on this topic.
9. Federal and state health ministers should require that guidance developed by the ACSQHC for the credentialing of medics who perform transvaginal mesh procedures should underpin credentialing in all public hospitals.
10. Medical professional colleges should implement arrangements for transvaginal mesh procedures which require their members are trained in the use of the device and are adequately skilled to perform the specific procedure.
11. State and territory governments should commission the ACSQHC to audit transvaginal mesh procedures undertaken and their outcomes.
12. The implant manufacturing industry and medical profession should work together to support high ethical standards.
13. State and territory governments should continue to work with ACSQHC to review the provision of services for the use and removal of transvaginal mesh devices and install a hotline and counseling programs.
https://www.buzzfeed.com/ginarushton/transvaginal-mesh-inquiry?utm_term=.gi7gndN6yg#.iywDvrWJqD
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Mar 29, 2018 | Stuff
By Cate Broughton
A Kiwi woman who spent $40,000 to have a United States surgeon remove her surgical mesh says New Zealand should follow the just-released recommendations from an Australian Senate inquiry.
Renate Schutte, 50, was implanted with a TVT-O mid-urethral sling in a procedure to treat stress urinary incontinence (SUI) in 2012. She developed severe burning pain in her groin and down her legs last August.
When Missouri surgeon Dr Dionysios Veronikis removed it, the groin pain disappeared "almost instantaneously".
Schutte considered herself fortunate to have been able to afford the treatment.
"There are so many people who can't do that, they haven't got any ACC cover, they have no private insurance and they are falling through the gaps, they've got nothing."
Schutte followed the progress of the Australian Senate inquiry into transvaginal mesh implants since it started in February last year. It released its report on Wednesday.
She said the recommendations were "fantastic" and she urged the New Zealand Government to consider them seriously.
"The Australians have basically done the work for us. The evidence is there, it's irrefutable they just need to carry on and do it."
The inquiry report included 13 recommendations including mandatory reporting of adverse events by medical practitioners; a registry for medical devices; improved informed consent processes; and that transvaginal mesh implantation only be undertaken with fully informed consent and as a last resort.
Senators heard harrowing stories from women at hearings in Sydney, Canberra, Perth and Melbourne and received more than 500 written submissions.
Women shared experiences of debilitating pain, physical limitations, social isolation and financial and emotional stress following surgery with mesh to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP).
One submitter, Joanne, said she could not sit down for longer than 15 minutes at a time and described the pain as feeling like she was being cut open and set alight.
"It's a deep, burning, searing ache that intensified with movement."
Submissions came from women who had positive experiences with mesh surgery and doctors and medical colleges supporting the use of mesh to treat SUI and POP.
The senate committee report acknowledged the successful outcomes many women treated with mesh experienced, but reprimanded those in the medical community who used this to downplay the experience of a minority of women suffering extreme adverse events.
"The committee considers that it is of no consolation to women who have lost so much to be told that they are part of a very small minority."
Instead the inquiry wanted "greater focus ... on understanding why some women experience positive life-changing outcomes and others experience catastrophe."
Of about 150,000 Australian women implanted with a mesh device, an unknown number experienced complications as there was no single source of information the committee found.
Under-reporting of adverse events was concerning and led to a recommendation to make it mandatory for medical practitioners.
The committee was concerned about the influence mesh suppliers had on surgeons, including financial inducements to use specific products.
"In particular, evidence that medical practitioners have proposed transvaginal mesh products as a "quick fix" or preventative option for minor symptoms of SUI or POP or been overenthusiastic in their embrace of this new technology is troubling."
It recommended relevant agencies review systems to "support consistent, high ethical standards, with specific emphasis on systems in place to prevent the payment of inducements to medical professionals and teaching hospitals".
NZ REGULATION 'OVERDUE FOR UPDATE'
Associate Minister of Health Julie Anne Genter said New Zealand's regulatory system had not been adequate to protect patients, and was "long overdue for an update".
A Therapeutic Devices Bill introduced this year would "ensure that this regulatory failure does not happen again".
"I agree with the Senate Inquiry that surgical mesh should only be used as a last resort, and want New Zealand women to have easier access to better quality information about the risks," Genter said.
Senior New Zealand members of the UroGynaecological Society of Australasia (UGSA) said they supported the Senate committee's recommendations, but were concerned about the statement that all mesh devices should be used as a last resort.
Limiting use of the mid-urethral sling, which had a good safety record for SUI treatment, would be a backward step for the one in three New Zealand women who suffer from incontinence as it would force doctors to "revert to more traditional, riskier surgical methods", they said.
The Royal Australian and New Zealand College of Gynaecologists (RANZCOG) said the Senate report highlighted that "more needs to be done to protect the safety of women" and committed to "implement governance arrangements" for transvaginal mesh procedures.
"It was very clear in the report that women who have experienced adverse complications as a result of a mesh implant have endured long-term pain and reduced quality of life. RANZCOG is not dismissive of these accounts and is profoundly sympathetic to all women who have had this experience," president Professor Steve Robson said.
https://www.stuff.co.nz/national/health/102689722/calls-for-nz-to-follow-australian-senate-surgical-mesh-report-which-says-use-it-as-last-resort
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Australian Senate Issues Report On Issues Surrounding Vaginal Mesh
Mar 30, 2018 | Immortal News
By Zye Angiwan
The report also noted that there has been considerable concern regarding whether or not health professionals had informed patients of the possible side effects of using these devices.
In addition, the senate stated the need for an improvement in awareness in the country’s reporting system. Steps to address the issue include setting up a national register to track all implants, added surgical training for removal of the implants, and coming up with special counseling programs to help women who have suffered injuries from the procedure.
Vaginal mesh implants are devices meant to fix common complications from childbirth or menopause. The procedure is quick, but carries a list of possible complications, such as organ perforation, hemorrhage, infection, and sexual dysfunction.
Women who experience pelvic prolapse – when the pelvic floor gets stretched and is unable to support the bladder, rectum and uterus – had also used vaginal mesh devices as a treatment. However, Australian authorities banned vaginal mesh implants for pelvic prolapse in November 2017.
The Health Issues Centre in Australia began a survey in order to obtain more information and statistics on vaginal mesh use, with dozens of women providing testimonies on how vaginal mesh use has affected them.
Implanting a vaginal mesh has become a standard procedure in Australia, instead of a last resort, resulting in numerous issues for patients. The Australian senate found that this procedure is being used on women without properly informing them of the risks involved.
The government has decided to step in after multiple women complained regarding their vaginal mesh implants, Tech Times reports. The Senate Community Affairs References Inquiries investigated the matter and released a report, stating that hundreds of women wrote to the senate to complain of pain they experienced after having a mesh implanted. These included being unable to sit or walk, and puncturing their partners with the vaginal mesh during intercourse.
https://www.immortal.org/37069/australian-senate-issues-report-on-issues-surrounding-vaginal-mesh/ -
NZ doctors argue for some uses for mesh
Mar 30, 2018 | NZ City
New Zealand doctors are arguing for the continued use of surgical mesh for some procedures after an Australian Senate committee inquiry said it should only be used as a last resort.
"It's very clear and highly regrettable that some women have been harmed by mesh surgery and this is obviously an area where we must focus our efforts in the future," says Dr John Short, the Christchurch-based vice-chair of the UroGynaecological Society of Australasia.
He says the bulk of mesh complications occur for vaginal prolapse and the rate of complications with mid urethral sling mesh for incontinence is much, much lower.
The report tabled in Australia's parliament on Wednesday made 13 recommendations.
Dr Short reiterated the statement by the profession on Wednesday that limiting the use of mesh would be a disservice to patients.
He says senior New Zealand members of the UGSA acknowledge and fully accept many recommendations from the extensive inquiry report, including the assurance that all women are fully informed and have a good understanding of any potential side-effects from surgical mesh prior to their procedure.
They also agreed that a centre of excellence be established in Australia to monitor transvaginal mesh use and complications, and for the introduction of central data collection and ongoing audit of all mesh use for women.
Limiting the use of mid urethral slings would force doctors to rely on more traditional types of surgical repair; using either a patient's own tissue (known as a fascial repair) or a procedure called a Burch Colposuspension, where permanent stitches were used to lift up the neck of the bladder.
Both are surgically complex, involving a lengthy hospital stay and post-operative recovery, with a greater risk of bleeding, wound infection, difficulty in passing urine and subsequent prolapse.
"Reverting to older, more traditional means of repair would be a backward step, exposing women to risks such as bleeding, thrombosis and infection," says Middlemore Hospital urogynaecologist Dr Lynsey Hayward.
"It would turn what's currently a simple day-stay procedure into a multi-day hospital stay, with six weeks off work to recover. I would probably be unable to treat around one third of the women I treat now, due to factors such as obesity, diabetes, other medical conditions and age, as these women are less able to tolerate lengthy abdominal surgery."
The mesh has been used since the 1990s to treat stress urinary incontinence and pelvic organ prolapse in women, with many experiencing severe impacts.
http://home.nzcity.co.nz/news/article.aspx?id=266649&cat=979&fm=newsmain%2Cnarts
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