Preview Newsletter
Ethicon Media Monitoring 3/28/2017
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Mesh implant campaigners 'betrayed' by report publication
Mar 27, 2017 | BBC
By Lucy Adams
Two campaigners against mesh implants say they are "dismayed and disgusted" at the publication of an independent report into their risks and use which they claim has been "watered down". -
Mesh implants should not be offered routinely to some women, panel concludes
Mar 28, 2017 | Press Association (In The Scotsman)
Mesh implant procedures must not be offered routinely to women with pelvic organ prolapse, a report has found. -
Mesh implants report branded 'establishment stitch-up' as continued use approved
Mar 28, 2017 | The Herald
By Helen McArdle
CONTROVERSIAL mesh implants will no longer be routinely offered to women with pelvic organ prolapse, and reporting of all procedures and adverse events involving the implants will be compulsory. However a report into their use has stopped short of recommending an outright ban. -
Mesh scandal report concludes that implants should not be offered routinely to some women
Mar 28, 2017 | Daily Record
By Hilary Duncanson
Thousands of women in Scotland have been treated using the implants but some have suffered painful and debilitating complications. -
Has AMS Paid All Transvaginal Mesh Claims?
Mar 27, 2017 | Mesh Medical Device Newsdesk
American Medical Systems/ Endo International says they are settling NO MORE CLAIMS, reports “Samantha” after a conversation with the national settlement firm. -
Pelvic prolapse surgery using mesh no more effective than standard repair?
Mar 27, 2017 | News Medical
What does pelvic prolapse surgery using mesh or graft involve and how does it differ from the existing standard repair technique? -
A Vicious Vagina: Woman Almost Severs Her Man’s Penis
Mar 27, 2017 | GlobalGrind
For one British woman’s vagina, sex became dangerous and outright bloody. -
Vagina With Teeth: Woman Claims Surgery Ruined Partner's Penis
Mar 27, 2017 | Nature World News
By Alixandra Caole Vila
A bladder operation has left a left woman's vagina like it had grown a teeth.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Mesh implant campaigners 'betrayed' by report publication
Mar 27, 2017 | BBC
By Lucy Adams
Two campaigners against mesh implants say they are "dismayed and disgusted" at the publication of an independent report into their risks and use which they claim has been "watered down".
Olive McIlroy and Elaine Holmes, who resigned from the mesh implants review group, said they felt "utterly betrayed" by the publication.
It was claimed that parts of the final report had been removed.
The Scottish government said it had accepted the recommendations in full.
The report said mesh implant procedures must not be offered routinely to women with pelvic organ prolapse.
The expert group concluded that patients should be offered a range of treatments - mesh and non-mesh - and must be given the information to make "informed choices".
Transvaginal mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.What's the issue with mesh implants?
Ms McIlroy, from Renfrew, and Ms Holmes, from Newton Mearns, both suffered severe complications following mesh implant surgery.
Following their resignations earlier this month, it emerged that a consultant also quit the expert group over concerns about the final draft of the report.
The consultant claimed that an entire chapter, which highlighted concerns about the use of mesh in some procedures and contained tables displaying the risks of treatment, had been taken out.
That chapter has been published but only as an attachment to the final report, and table two from that chapter - which highlights the risks of mesh implants - is still missing altogether.Mesh must not be offered routinely to women with pelvic organ prolapseReporting of all procedures and adverse events should be mandatoryExtra steps to ensure patients have access to clear, understandable advice to help them make informed choicesCalls for improved training and researchAll treatments should be made available to treat incontinence - including mesh
The final report states: "It is clear that a number of women have suffered serious, life-changing complications following transvaginal mesh implant surgery.
"It is also evident that many women have benefited from these procedures.
"However, due to the way these procedures are coded, it is not possible to provide accurate data on the number of mesh procedures where complications have occurred.
"This lack of information, allied with the fact that adverse events have been under-reported, has led to opinion being divided on the safety of transvaginal mesh procedures."
The Scottish government said it would now set up an oversight group to ensure the recommendations were implemented.
Former health secretary Alex Neil described the decision to publish the report without investigating claims of a whitewash to be "totally unacceptable".'Not in our name'
In a joint statement, Ms McIlroy and Ms Holmes said: "We are dismayed and disgusted that the Scottish government have seen fit to publish this tainted report despite all the concerns raised by us and the expert who resigned in protest over missing vital evidence and safety warnings on mesh.
"We are furious that our name has not been removed from a report which we believe is nothing more than a whitewash and a betrayal of every one of the hundreds of Scottish women who have had their lives devastated by the injuries caused by mesh implants, and their families.
"We are seeking legal advice on the matter as we have repeatedly told both the head of the review and Health Secretary Shona Robison that our names must be removed from this report, and any input we have had be withdrawn.
"The report as it stands is most certainly not in our name."
They added: "Almost 100 MSPs have signed a pledge promising there will be no whitewash on mesh. We are taken aback that Shona Robison has chosen to ignore everyone who has raised concerns.
"Every single women who is injured in the future can now lay the responsibility squarely at the door of Shona Robison. We feel utterly betrayed."
Over the past 20 years, more than 20,000 women in Scotland have had mesh or tape implants but some have suffered painful and debilitating complications.
There are more than 400 women currently taking legal action against Scottish health boards and manufacturers as a result of mesh implant surgery.Suspension request
In 2014, campaigners gave evidence to the Holyrood Petitions Committee. Several of them were in wheelchairs, unable to walk because of surgical complications.
As a result Alex Neil, the Scottish government's health secretary at the time, wrote to health boards requesting a suspension in the use of mesh implants by the NHS in Scotland, pending the review group's investigation into their safety.
An interim report was delivered in October 2015 with the final report now published.
Mr Neil - who is now a backbench MSP - said: "This is totally unacceptable if they have published and accepted this report without these allegations being fully investigated. If there has been a cover-up, then this needs to be investigated. There now needs to be an independent review of the process."
Dr Catherine Calderwood, Scotland's chief medical officer, said: "I want to thank this independent review for their hard work over a lengthy period of time. This is a highly complex and technical subject area and they had a wide range of evidence to consider.
"The group included a wide range of people with differing views and all of their contributions have been very valuable.
"On behalf of the Scottish government I am today accepting the conclusions of the review group. It is vital that women are given all the available information before they decide whether to go ahead with a mesh procedure. It is also right that all adverse events are properly reported so that we can continue to improve safety and positive outcomes."'Final stages marred'
She added: "We must remember that this review came about because of the tireless campaigning of women who have been negatively impacted by mesh procedures. It is right that we recognise the courage of these women, which has brought us to this point today.
"I want patients to have the best and most up-to-date information on which to base their decisions - in discussion with their clinicians. I will be looking for the newly-formed oversight group to ensure this happens."
Tracey Gillies, chairwoman of the independent review, said: "The final stages of completion of the review have been marred by suggestions that evidence has been destroyed or is missing, "I am confident that is not so and have written to the cabinet secretary for health and sport setting out the approach taken. The material presented by one group member and not included in the final report is available on the website with the declarations of interest from group members."
She added: "I have no doubt that the implementation of the conclusions in this report will provide benefit to women across Scotland, and will provide clinicians with additional tools to support their engagement with realising realistic medicine, allowing better decisions to be made jointly with patients."
Labour MSP Neil Findlay said the review was "every bit the establishment stitch-up the Scottish mesh survivors said it would be".
"Essential information has been omitted, reports overlooked and data hidden to ensure the review presents what I suspect was a predetermined position from day 1 in favour of continuing to implant mesh which has caused so many women long-term, life-changing damage to their health."
http://www.bbc.com/news/uk-scotland-39408064
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Mesh implants should not be offered routinely to some women, panel concludes
Mar 28, 2017 | Press Association (In The Scotsman)
Mesh implant procedures must not be offered routinely to women with pelvic organ prolapse, a report has found.
A panel concluded patients should be offered a range of treatments - mesh and non-mesh - and must be given the information to make "informed choices".
In doing so, they voiced serious concern that some women who have suffered complications following mesh implant surgery have felt they were not being believed - a factor which added to their distress.
Experts also called for the mandatory reporting of all mesh procedures and "adverse events".
The measures in the report on the use of transvaginal mesh implants have been accepted by Scotland's Chief Medical Officer (CMO) Dr Catherine Calderwood.
Synthetic transvaginal tapes and meshes are used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Thousands of women in Scotland have been treated using the implants but some have suffered painful and debilitating complications.
In June 2014, then health secretary Alex Neil asked health boards to suspend the use of the implants after a campaign by women who have suffered serious side effects.
An independent review was also set up, with its final report made public on Monday.
The report concludes that no surgery is without risk and sets out various recommendations to minimise any potential risk
"This IR (independent review) has shown that mesh procedures for both SUI and POP carry a risk of complications which, in some cases, are life changing and cannot be corrected," the report notes.
"However, for the majority, such serious complications do not occur."
The report sets out eight conclusions to improve the safeguards available; one being that "transvaginal mesh procedures must not be offered routinely".
Another recommendation states that "women must be offered all appropriate treatments (mesh and non-mesh)" and they should have access to understandable advice to help them make informed choices.
Another recommendation states that "women must be offered all appropriate treatments (mesh and non-mesh)" and they should have access to understandable advice to help them make informed choices. The report says: "The IR expressed serious concern that some women who had adverse events felt they were not believed, adding to their distress and increasing the time before any remedial intervention could take place."
The review also called for improved training for clinical teams involved in mesh surgery and more research into the safety of the products.Responding to the report, Dr Calderwood said: "On behalf of the Scottish Government I am today accepting the conclusions of the review group. It is vital that women are given all the available information before they decide whether to go ahead with a mesh procedure. It is also right that all adverse events are properly reported so that we can continue to improve safety and positive outcomes.
"We must remember that this review came about because of the tireless campaigning of women who have been negatively impacted by mesh procedures. It is right that we recognise the courage of these women, which has brought us to this point today."
Earlier this month, MSPs raised concerns over the independence of the review group. The issue was brought to Holyrood after some women who suffered complications following mesh implant surgery resigned from the group.Labour MSP Neil Findlay said the review had been ''completely compromised''. Tory MSP Jackson Carlaw said he had been contacted by others within the group who were "astonished at the wholesale removal of certain chapters" from the report.
http://www.scotsman.com/news/mesh-implants-should-not-be-offered-routinely-to-some-women-panel-concludes-1-4404781 -
Mesh implants report branded 'establishment stitch-up' as continued use approved
Mar 28, 2017 | The Herald
By Helen McArdle
CONTROVERSIAL mesh implants will no longer be routinely offered to women with pelvic organ prolapse, and reporting of all procedures and adverse events involving the implants will be compulsory. However a report into their use has stopped short of recommending an outright ban.
The findings of the Scottish Government's independent review into the safety of transvaginal mesh implants follows accusations that the final report would be a "whitewash". Two patient representatives and one expert consultant resigned from the review group after it emerged that an entire chapter of the final report had been removed.
Tracey Gillies, who chaired the review, said completion of the final report had been "marred by suggestions that evidence has been destroyed or is missing", but stressed that she was "confident that is not so".
She added: "The material presented by one group member and not included in the final report is available on the website with the Declarations of Interest from group members."
The review was launched in 2014 amid concerns over patients suffering painful and disabling complications following surgery with the mesh products to treat stress urinary incontinence or to repair pelvic organ prolapse - a condition which can occur when abdominal muscles are weakened during childbirth. At that time around 1,850 women were undergoing the procedure in Scotland every year, but the report said it was "not possible to provide accurate data" on how many patients experienced complications. While some women had suffered "life changing complications" it was "also evident that many women have benefitted", said the report.
However, it concluded that mesh procedures "must not be offered routinely" to women with prolapse as the "current evidence does not indicate any additional benefit" over tissue repair. Meanwhile, patients with stress incontinence "must be offered all appropriate treatments", including mesh and non-mesh.
The report also recommends that the reporting of all mesh procedures and adverse events must be mandatory, and calls for more research into mesh safety, clearer guidance for patients and improved training for clinicians.
Labour MSP and chair of Holyrood's Health and Sport Committee, Neil Findlay, said the report was an "establishment stitch up". He added: “Essential information has been omitted, reports overlooked and data hidden to ensure the review presents what I suspect was a predetermined position from day one in favour of continuing to implant mesh which has caused so many women long term, life changing damage to their health."
Dr Catherine Calderwood, Scotland’s Chief Medical Officer, said she accepted the conclusions. She said:
“This is a highly complex and technical subject area and they had a wide range of evidence to consider.”
http://www.heraldscotland.com/news/15184962.Mesh_implants_report_branded___39_establishment_stitch_up__39__as_continued_use_approved/
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Mesh scandal report concludes that implants should not be offered routinely to some women
Mar 28, 2017 | Daily Record
By Hilary Duncanson
Thousands of women in Scotland have been treated using the implants but some have suffered painful and debilitating complications.
Mesh implant procedures must not be offered routinely to women with pelvic organ prolapse, a report has found.
A panel concluded patients should be offered a range of treatments - mesh and non-mesh - and must be given the information to make "informed choices".
In doing so, they voiced serious concern that some women who have suffered complications following mesh implant surgery have felt they were not being believed - a factor which added to their distress.
Experts also called for the mandatory reporting of all mesh procedures and "adverse events".
The measures in the report on the use of transvaginal mesh implants have been accepted by Scotland's Chief Medical Officer (CMO) Dr Catherine Calderwood.
Synthetic transvaginal tapes and meshes are used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Thousands of women in Scotland have been treated using the implants but some have suffered painful and debilitating complications.
In June 2014, then health secretary Alex Neil asked health boards to suspend the use of the implants after a campaign by women who have suffered serious side effects.
An independent review was also set up, with its final report made public today.
The report concludes that no surgery is without risk and sets out various recommendations to minimise any potential risk.
"This IR (independent review) has shown that mesh procedures for both SUI and POP carry a risk of complications which, in some cases, are life changing and cannot be corrected," the report notes.
"However, for the majority, such serious complications do not occur."
The report sets out eight conclusions to improve the safeguards available; one being that "transvaginal mesh procedures must not be offered routinely".
Another recommendation states that "women must be offered all appropriate treatments (mesh and non-mesh)" and they should have access to understandable advice to help them make informed choices.
The report says: "The IR expressed serious concern that some women who had adverse events felt they were not believed, adding to their distress and increasing the time before any remedial intervention could take place."
The review also called for improved training for clinical teams involved in mesh surgery and more research into the safety of the products.
Responding to the report, Dr Calderwood said: "On behalf of the Scottish Government I am today accepting the conclusions of the review group.
"It is vital that women are given all the available information before they decide whether to go ahead with a mesh procedure. It is also right that all adverse events are properly reported so that we can continue to improve safety and positive outcomes.
"We must remember that this review came about because of the tireless campaigning of women who have been negatively impacted by mesh procedures. It is right that we recognise the courage of these women, which has brought us to this point today."
Earlier this month, MSPs raised concerns over the independence of the review group. The issue was brought to Holyrood after some women who suffered complications following mesh implant surgery resigned from the group.
Labour MSP Neil Findlay said the review had been "completely compromised". Tory MSP Jackson Carlaw said he had been contacted by others within the group who were "astonished at the wholesale removal of certain chapters" from the report.
http://www.dailyrecord.co.uk/news/health/mesh-scandal-report-concludes-implants-10109236
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Has AMS Paid All Transvaginal Mesh Claims?
Mar 27, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, May 27, 2017 ~ American Medical Systems/ Endo International says they are settling NO MORE CLAIMS, reports “Samantha” after a conversation with the national settlement firm.
Samantha has vigorously pursued AMS for its patented surgical tools used in the Caldera mesh kit that injured her.
Samantha was implanted in the T-Sling made by Caldera in 2004, before it was even cleared for experimental use, at HealthSouth in Birmingham, Alabama. Her implanting surgeon was one of the co-inventors, she says, something she was not told at the time but which she discovered later.
“If you believe you will obtain a settlement from AMS you might want to know that it is most likely not going to happen. They are on defensive now that the novel surgical tools are identified and are a new viable set of claims against their national settlement funds,” she tells MND.
Samantha, who is not represented legally but may be in the future, prefers not to be identified. She spoke with the law firm overseeing the AMS/Endo $1.6 billion Qualified Settlement Fund (QSF) March 17.
In a series of e-mails, Amy Rhoe, attorney for Reisman Karron Greene LLP, confirmed the new national legal position for Astro Endo Pharma Position is NO MORE SETTLEMENTS will be paid.
In response to clarification, whether AMS/Endo was ending transvaginal mesh settlements, Rohe wrote MND, “The statements in your email are incorrect.”
Negotiations between plaintiffs’ lawyers and the company are reportedly still resulting in some case resolution, but Samantha is proceeding Pro Se, after she fired he law firm. With no one representing her interests, and being implanted outside of the years Caldera Medical had insurance coverage, Samantha is further disadvantaged in this litigation.
What’s unclear is whether future claims may be filed against the $1.6 billion QSF or whether the pending mesh product liability cases will be satisfied.
There are already limitations to covered claims. The QSF does not pay for future injuries and there is a cut-off date of December 31, 2016 for applying for a supplemental settlement amount.
At one time, Judge Goodwin, overseeing pelvic mesh litigation, heralded AMS as the example the other six mesh manufacturers should follow to the settlement table. Now that progress has reportedly stalled.
Older AMS cases are lingering after dollar amounts were rejected by the mesh-injured plaintiffs, and according to Endo, an additional 9,700 product liability pelvic mesh claims have been filed.
The pelvic mesh litigation that was supposed to be the first resolved has failed to do so.
Is the AMS/Endo Settlement Near the End?In 2011, Endo Pharmaceuticals agreed to acquire American Medical Systems for $2.9 billion in cash for its urology medical devices. The AMS deal would be a bad one for Endo. The merger resulted in Astora Women’s Health, which closed its doors one year ago due to the mounting cost of pelvic mesh litigation.
In September 2014, AMS/Endo announced it was committing $1.6 billion into the Qualified Settlement Fund to close its pelvic mesh cases.
Its latest securities filing for 2016, Endo International, based in Dublin, Ireland, shows cash payments to mesh-related product liability and other litigation matters in excess of the $1.6. billion QSF. The mesh-related activities include cash payments to claimants in 2016 of $1.1 billion and $676 million for 2015. See the Endo SEC 10-K here and here.
According to the filing, AMS/Endo settled 49,000 filed and unfiled mesh claims with, no admission of liability or fault as of December 31, 2016.
The SEC filing says, “It is currently not possible to estimate the number or validity of any such future claims.” The company no longer has product liability insurance to cover the claims in connection with the mesh-related litigation settlement.
Is it accurate to say then that Endo payments into the settlement fund, for the time being, have been satisfied? I asked Amy Rohe for a second time.
“That is not correct. My client has no additional comments with respect to settlements at this time,”writes Rohe in an email.
STEEP DECLINE
The settlement is a drain on a company already in a steep decline.
Last June, Endo stock plummeted and by December, Fierce Pharma reported Endo planned to cut loose 375 sales reps and staffers.
Today Endo International plc is near its lowest point in a year, closing up today at $10.50 USD. The week of January 31, 2017, Endo was the worst performing stock in the S&P 500, in fact, twice in one week.
Adding insult to injury, last week two FDA advisory panels said that Endo’s moneymaker opioid, OPANA and OPANA ER do not provide more benefit than risk. The extended release, which was supposed to be an improved version, might be even more dangerous than the original, concluded Public Citizen.
It will be up to the FDA to decide whether to require label changes, restrict prescriptions or take OPANA off the market. For the present time, OPANA remains on the market with additional warnings.
LEGAL FEES
Endo continues to pay hundreds of thousands of dollars in legal fees to defend all of its problematic products but appears to have given a green light to lawyers pursing a mesh-related alleged”scheme” to undergo additional surgeries for additional settlement dollars.
According to recent filings in the federal multidistrict litigation in Charleston WV, AMS/ Endo is pursuing Broward Outpatient Medical Center and Beth Israel Surgical Center to provide medical records on 32 plaintiffs, women implanted with AMS transvaginal mesh. To date, the hospital had not complied with the subpoenas requested by AMS attorneys on or about November 23, 2016.
Attorneys for Reed Smith law firm representing AMS/Endo believe mesh-injured women are willing to undergo additional pelvic surgeries to increase their settlement dollars. The Tier system used to gauge injury and compensation is based on the number of mesh-removal surgeries a woman undergoes. See MND Pain for Profit story here.
The alleged “lured into needless surgeries” scheme has been reported numerous times by Reutersand is repeated in this recent column.
As if there was not enough litigation to go around, Reed Smith, is facing accusations of questionable practices of its own, as reported by ReedSmithWatch.com, The website says partners, bill upwards of $700 an hour.SAMANTHA URGES CALDERA MESH IMPLANTED TO PURSUE AMS/ENDO
For Samantha, her argument is that the surgical tools included in the Caldera T-Sling were patented and owned by AMS, therefore she believes have value to her case.
Samantha continues, ” My journey has been long and difficult. All Caldera Medical Inc. victims should file a short form in the American Medical System MDL and demand payment from the national fund. I have an open insurance claim against AMS/Endo. I filed with ACE Chubb Group after locating the general liability policy through an insurance agent, Marsh U.S.A. I opened my claim on March of 2016 which is based in my injuries by the predevelopment use of AMS patent US6911003.
“The patent is for the helical introducer, inside-out introducer, hook introducer for the transobturator procedure are instruments whose use and IP method have injured me.
“After more than a year of communicating with an adjuster, my claim was directed to American Medical Systems National Settlement law firm and attorney Amy Rhoe.”
The context of the communication was as follows:
“It is my hope you are able to authorize a settlement offer as Astro / Endo Reached Master Settlement Agreement to Resolve Substantially All Remaining AMS Mesh Litigation Claims, in September of 2014. I was implanted with an assembly kit which contained the AMS novel surgical tools during the window of time where AMS was infringing upon Mentor and AMS and Caldera Medical, Inc. agreed to a royalty agreement for the novel surgical tools.
I was an unethical human experiment 22 months before the FDA was aware of the Caldera mesh assembly kit. It should be of concern to you as to how AMS was involved with HealthSouth in participating in my harm. Funds are set aside for settlement and ACE Chubb’s insurance adjuster directed me to contact Endo directly because all proceeds from the general liability policy had been paid into the fund. You can authorize the payment of my claim.
I am asking you authorize a settlement from the fund for my claim. My harm has never been denied by the insurance company. Life Science policies do not cover for harm outside of clinical trials of which I was not. Clinical trials did not begin until 2006. If Endo is unaware of the unethical human experimentation that American Medical Systems used to bring products to market, that should be addressed internally I, however, should be compensated for my harm.
I do not have legal representation because Multidistrict Litigation attorneys operate within collusive private deals which have hidden the criminal unethical human experimentation surrounding my harm, the Stark’s Law and False Claims violations and avoid prosecution so they can take their monies for legal fees and commissions while ignoring the predevelopment unethical human experiment that brought devices to market.
When I had initial contact with you, I indicated that I had information that you might not be aware of. That information concerns this question.
Do you know how American Medical Systems helical passer needles were used in the assembly kit use to implant me on April 20, 2004, at HealthSouth Alabama, 22 months before the FDA was aware of the implant?
Please review all 42 images of the patent, it will provide images for my harm. Here is the patent for Transobturator surgical articles and methods. My claim is based upon Patent 6911003 B2 CLAIMS (14) (here).
I look forward to our phone conversation today. Please review all 42 images of patent, I have provided image 11.
Again, I ask you to authorize a settlement offer from the current 2014 settlement fund.”
http://www.meshmedicaldevicenewsdesk.com/ams-paid-transvaginal-mesh-claims/
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Pelvic prolapse surgery using mesh no more effective than standard repair?
Mar 27, 2017 | News Medical
What does pelvic prolapse surgery using mesh or graft involve and how does it differ from the existing standard repair technique?Women who have surgery for their prolapse have a 3 in 10 chance of needing at least one more operation, so the success rate is not great.
Gynecologists hoped that using non-absorbable synthetic mesh or biological graft material as a patch to reinforce their standard repairs, the success rate would get better.
This approach has worked very successfully for patients having hernia repairs while initial summaries of evidence seemed to show that it might work for women having prolapse surgery too.Why is the use of mesh and graft in prolapse surgery a controversial topic?
However, some women have reported long-term health problems after prolapse surgery with mesh, and this has led to considerable medico-legal interest as well as several investigations by regulatory bodies.
The evidence for the benefits of using mesh or grafts was of poor quality or inconclusive until the publication of PROSPECT.Can you please outline your recent research project comparing the outcome of pelvic organ prolapse repairs?
PROSPECT was a pragmatic, multicenter randomized controlled trial conducted in 35 centers across the UK. Women undergoing their first operation for prolapse were randomized to having a standard repair of the front or back wall of the vagina, or a repair reinforced by synthetic non-absorbable mesh, or a biological graft.
We measured the outcomes of surgery at 6 months and 1 and 2 years afterwards, mostly by asking women to fill in questionnaires about their symptoms and health. We also examined them at 1 year.What were your main findings?
We found that, in contrast to previous research, women were just as likely to be cured after standard surgery as after the reinforced repairs. They were just as likely to have other symptoms such as bladder or sexual problems, and other adverse effects such as infection, bleeding or pain.
However, about 1 in 10 of the women who had mesh did have mesh exposure (when a, usually small, portion of the mesh becomes visible through the vaginal wall). Although not all women had symptoms, about half of those women needed a small operation to remove or bury the exposed mesh.
So there were no clear benefits from the use of mesh or graft over a standard repair in women having their first operation. However, synthetic mesh did result in some complications which posed extra risk.
Two other papers published on line in the Lancet on 21 December 2016 have drawn attention to other aspects of care for women with pelvic floor dysfunction.
Researchers from the Information Services Division have shown that long term results from mesh prolapse surgery are no better than from standard repair, echoing the PROSPECT findings (Morling et al; http://www.thelancet.com/journals/lancet/onlineFirst).
Indeed their longer time span showed that women had increased risks of later complications as well as being more likely to need further prolapse or continence surgery.
The PrevProl study showed that pelvic floor exercises should be tried as a first line as they have been shown to reduce prolapse symptoms or prevent their progression, at least in the short term (Hagen et al; http://www.thelancet.com/journals/lancet/onlineFirst). Women can also reduce risk factors for prolapse such as by treating obesity, heavy lifting and chronic cough.
Prevention and conservative treatment such as using pessaries can avert or delay surgery. However, if these fail, women should be reassured that if they do need surgery, they ought to go ahead with standard operations, while being aware of the risks and chance of failure.
Were you surprised by the results?
Yes, because the most rigorous summary of all previous RCTs on the use of mesh (most recently updated in February 2016, Maher et al) suggested that the use of non-absorbable mesh in prolapse surgery was better in terms of both anatomical cure and prolapse symptoms than surgery without mesh.
Our trial clearly showed that there was no difference in any of the outcomes measured. We did, however, provide reliable evidence to confirm the finding of no extra benefit from the use of biological grafts.
Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database of Systematic Reviews 2016, Issue 2. Art. No.: CD012079. DOI: 10.1002/14651858.CD012079How do your findings compare to previous studies?
Our trial has reliably shown for the first time that women having their first prolapse operation do not benefit from the use of non-absorbable mesh, in contrast to the amalgamated results of all previous RCTs (Maher et al). We also provided reliable evidence that biological grafts do not help either.What impact do you think your findings will have?
Women contemplating having their first prolapse operation can now be reliably counseled to avoid mesh inlays as these will not improve their chances of benefit from the operation. They may lead to unwanted side effects, some of which may require further surgery. Neither will they benefit from the use of biological grafts. Using either type of inlay is more expensive than standard surgery alone.What further research is required?
We still need to find a way of making prolapse surgery work better, so that more women will be cured without needing further surgery for prolapse or side effects. The jury is still out on whether women having repeat surgery, or women at high risk of failure, may still benefit from mesh.
We also need to find acceptable alternatives to surgery which cure women’s symptoms without exposing them to excess risk.What do you think the future holds for pelvic prolapse surgery?
With an ageing population, more women than ever before will require prolapse surgery. Traditional surgery, however carried out, has a 30% chance of failure. We need to identify which women will benefit most, and which type of surgery works best.
It may be that some women have specific risk factors which make failure more likely. The risk of failure rises with each successive operation. Perhaps the best strategy is to try to avoid surgery (for example by the use of pelvic floor muscle training or pessaries) so that surgery is reserved for women for whom other treatments are unsuitable or when all else has failed.
Whichever route is chosen to treat women with prolapse, it is essential that they are counseled in a realistic and evidence-based way so that they can truly understand the risks and benefits of different approaches.Where can readers find more information?
http://www.news-medical.net/news/20170327/Pelvic-prolapse-surgery-using-mesh-no-more-effective-than-standard-repair.aspx
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A Vicious Vagina: Woman Almost Severs Her Man’s Penis
Mar 27, 2017 | GlobalGrind
For one British woman’s vagina, sex became dangerous and outright bloody.
50-year-old Theresa Bartram’s issues started when she suffered from stress incontinence after giving birth to her only child. This brought her sex life to a halt and after seven years without sex, she decided to do something about it.
Bartram underwent an operation to lift her prolapsed bladder with a plastic mesh sling called transvaginal tape. This prevented leaking she endured due to her incontinence.
Before long, Bartram was back in the sex game. However, things took a horrible turn when in 2009 her vagina almost cut off her partner’s penis.
“It was like it had grown teeth,” she explained. “His willy was bright red and spouting blood. There was a big red stain spreading between us on the sheets. After that, he was scared of my lady garden and approached it as if it was a Venus flytrap and he was a bluebottle (fly).”
Bartram suspected the mesh inside her caused the gruesome encounter, but her doctor kept assuring her that everything was fine.
Six months later, her and her partner broke up and Bartram was terrified to have vaginal intercourse again. She went on a diet and began exercising, but a few months later health problems started surfacing. Bartram’s stomach started to bloat and she was suffering from severe stomachaches, diarrhea, and vomiting. She was diagnosed with irritable bowel syndrome and was prescribed antidepressants. Eventually, her gallbladder was removed.
In 2015, after all of this, Bartram was finally told that she had to get the mesh inside her removed. It had breached her vaginal wall and resulted in an abscess that turned septic. During her surgery, it was revealed that the mesh, which was fitted too low, had turned hard. This is what caused the mutilation of her ex-lover’s penis. “It felt like razor-sharp teeth,” Bartram said.
The removal of the mesh caused Bartram to be incontinent again. Bartram now deeply regrets the transvaginal tape procedure. She explained, “I was told this simple procedure would cure my incontinence and give me more confidence on the bedroom, but it has ruined my life.” She continued, “It made my vagina deadly and forced me into a life of celibacy. It could have killed me…I’m pleased the mesh is gone but it has left my body and my vagina a total mess. I wear padding all the time and sleep on incontinence sheets.”
Such an unfortunate series of events for Bartram. It seems she’s not the only one. The mesh insertion procedure she underwent has been suspended in Scotland and is under scrutiny worldwide. Batram has joined a group, Sling The Mesh, to help fight the problematic medical procedure.
https://globalgrind.com/4221358/a-vicious-vagina-woman-almost-severs-her-mans-penis/
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Vagina With Teeth: Woman Claims Surgery Ruined Partner's Penis
Mar 27, 2017 | Nature World News
By Alixandra Caole Vila
A bladder operation has left a left woman's vagina like it had grown a teeth.
Theresa Bartram, 50, had suffered from stress incontinence after giving birth to her first child, New York Post reported.
Since then, she have not had sex. To bring back her confidence, she underwent a Tension-Free Vaginal Tape procedure (TVT), a bladder operation using a plastic mesh. However, she realized a few months after that the mesh called TVT, which stopped her from leaking, was fitted to low that it reached her vaginal wall.
According to Bartram, it was in 2009 when his partner's penis was almost cut off by her vagina, which she compared to a venus flytrap.
"It was like it had grown teeth. His willy was bright red and spouting blood. There was a big red stain spreading between us on the sheets," she told Metro News.
After that incident, they stopped having sex and eventually broke up. To make matters worse, she started leaking again in 2015.
The Sun noted that she went to visit the doctors who operated on her but she was assured a couple of times that the mesh is fine. Her health declined, her gallbladder was removed and she saw 25 different doctors.
Only in 2015 that he got properly examined when puss formed and began leaking green excretions. She had to go an operation. The doctors found out the mesh shrunk and turned hard.
"It felt like razor-sharp teeth, hence why it had ripped a chunk from my boyfriend's willy," she explained.
Web MD notes that the TVT procedure is designed to provide support for a sagging urethra.
However, many women are protesting to suspend the TVT procedure. BBC said in Scotland, health secretary called for their use to be suspended in June 2014 because of the complications.
http://www.natureworldnews.com/articles/36777/20170327/vagina-with-teeth-woman-claims-surgery-ruined-partners-penis.htm
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