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Ethicon Media Monitoring 10/31/2017
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UK Transvaginal Mesh Debate Resonates Across Globe
Oct 30, 2017 | Drugwatch
By Michelle Llamas
Despite a heated campaign by women harmed by pelvic mesh, Britain’s Parliament recently refused to ban the surgical device, ruling out a public inquiry or temporary ban. -
All Mesh “High Risk” in Australia
Oct 30, 2017 | Mesh Medical Device Newsdesk
In a quiet but striking move, Australia drug and medical device regulator has strengthened the classification on pelvic mesh, increasing the likelihood it will not be used, especially as a first-line treatment. -
Give us back the tools to repair pelvic prolapse in women
Oct 31, 2017 | Financial Review
By Jill Margo
Fed up with fighting the medical establishment over how to treat intimate female problems, a Sydney specialist has fired off a new book aimed directly at the women he believes are being denied a beneficial treatment. -
Scandal of the implant prolift : Should We Be Concerned About In France ?
Oct 31, 2017 | The Stopru
Pain permanent, inability to walk or having sex with thousands of women around the world say they are victims of a denture of French origin. Used to treat the descent of the organs (or organ prolapse) and incontinence after childbirth, the implant Prolift can be split into the vagina and cause discomfort to severe, as has denounced the Obs in a recent survey. But in France, does it matter to alert ?
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UK Transvaginal Mesh Debate Resonates Across Globe
Oct 30, 2017 | Drugwatch
By Michelle Llamas
Despite a heated campaign by women harmed by pelvic mesh, Britain’s Parliament recently refused to ban the surgical device, ruling out a public inquiry or temporary ban.
The decision on October 18, 2017 drew criticism from members of Parliament and women injured by mesh — including women in the U.S.
Parliament did not ban the product or suspend its use because it contends pelvic-mesh complications are the result of implantation problems — not product defects, according to Jackie Doyle-Price, parliamentary under secretary of State for Health (Care and Mental Health).
Alec Shelbrooke, Conservative member of Parliament for Elmet and Rothwell, called the mesh scandal the “new thalidomide,” referring to a controversial drug that caused birth defects in thousands of children in the late 1950s and early 1960s.
Founder of the U.K. advocacy group Sling the Mesh, Kath Sansom, called vaginal implants “the stuff of nightmares.”
“The latest UK study by seven medics reckons 1 in 10 suffer complications [from mesh],” Sansom told Drugwatch. “I think the government did not suspend the use of mesh because they fear litigation.”
Transvaginal mesh — also called pelvic mesh — is a flexible, net-like plastic implant. Surgeons use it to treat pelvic organ prolapse, a condition where organs sag into the vagina. They also use it to treat stress urinary incontinence, or leaking of urine after coughing or sneezing.
The mesh forms a hammock under organs and supports weak pelvic tissues or the neck of the bladder.
Although doctors consider mesh the gold standard of care for prolapse and incontinence, thousands of women have reported serious complications after the procedure. These include autoimmune disorders, organ perforation, severe bleeding, pelvic pain, pain during sex, recurrence of incontinence, bowel blockages and other problems.
In the U.K., at least 130,000 women had mesh implanted in the last 10 years alone, but the numbers are difficult to verify, Sansom told Drugwatch by email.Thousands Affected by Mesh in US
Mesh-injured women in the U.S. are outraged about Parliament’s decision.
Janis Urban is one of thousands of American women who continues to suffer complications from pelvic mesh and now fights to spread awareness through social media.
“I think we need to have a revolution after the U.K.’s Parliament decision,” Urban told Drugwatch.
According to data provided by medical-device consultant Madris Tomes of Device Events, there have been nearly 114,000 U.S. Food and Drug Administration reports of injuries linked to mesh — including 1,152 deaths — since 2004.
Despite the ongoing controversy, reports of mesh complications in the U.S. have gone downdramatically since 2013. Several factors may have contributed to the decline, Tomes told Drugwatch.
“When transvaginal mesh was reclassified to Class III it may have affected physicians’ willingness to use it,” Tomes said in an email. “That would account for the decrease. Certainly there are a lot of attorneys taking mesh cases so that would deter patients from allowing their physicians to use it.”Expert: Patients Should Seek Justice through the Courts
Advocacy groups in the U.K. and the U.S. seek a ban on pelvic mesh, but it may be difficult to achieve.
Dr. Hooman Noorchashm has been an outspoken advocate for women’s health since he and wife Dr. Amy Reed campaigned to spread awareness about power morcellators.
The FDA found the drill-like surgical device could spread undiagnosed uterine cancer. Reed died in May 2017 from cancer spread by the device after a hysterectomy.
“Pelvic mesh should be banned,” Noorchashm told Drugwatch. “It is used in an area that is prone to infection because of naturally occurring bacteria, and it is implanted by poorly trained surgeons.”
While he supports a ban, Noorchashm said it is not the job of Parliament or Congress to enact one. What the government should do, he said, is to allow an inquiry and ensure women have the right to file lawsuits against manufacturers.
Thousands of American women have already turned to the courts for justice.
As of October 16, 2017, the United States Judicial Panel on Multidistrict Litigation reported there were still over 42,000 active federal mesh cases. At one time, the number soared well over 100,000.
Several manufacturers have already offered billions in settlements and jury verdicts.
Despite the decision by Parliament, U.K. the mesh battle will continue.
“The fight goes on to get a suspension, a public inquiry and eventually a pelvic mesh ban,” Sansom said. “Women suffering with mesh in the U.K. join should join Sling The Mesh, Scottish Mesh Surviors, Meshed up NI, Welsh Mesh Survivors or any of the other groups globally to get advice from women who understand and care.”
https://www.drugwatch.com/2017/10/30/uk-transvaginal-mesh-debate-resonates-across-globe/
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All Mesh “High Risk” in Australia
Oct 30, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, October 30, 2017 ~ In a quiet but striking move, Australia drug and medical device regulator has strengthened the classification on pelvic mesh, increasing the likelihood it will not be used, especially as a first-line treatment.
If you were not paying attention you might not have noticed an announcement last Thursday, October 26.
All pelvic mesh devices in Australia are to be reclassified from moderate to “high risk” over the next 24 months.
The announcement was made on the Therapeutic Goods Administration (TGA) website (here), the Australian version of the U.S. Food and Drug Administration. The reclassification will begin in December 2018, for the larger pelvic organ prolapse (POP) mesh, used to treat falling pelvic organs. That gives POP mesh manufacturers 14 months to make the change.
At the same time, the smaller “tape” or “slings” used to treat stress urinary incontinence (SUI) will be upgraded to high risk by December, 2020, a full 26 months away.
A three-year transition period to December 2021 is proposed to apply for other surgical mesh devices such as hernia mesh.
The TGA is part of the Australian Government Department Of Health and it regulates medicine, vitamins, med devices and blood products.
he change is significant.
Patient cards for implantable med devices will be required for all new urogynecological mesh devices from Dec 1, 2018. At that time manufacturers of new permanently implantable devices will need to have a patient information leaflet in the TGA approved format.
After the dates above, mesh manufacturers must provide a “higher evidentiary requirement” before they are approved for sale.
The changes were approved by Health Minister Greg Hunt and follow an Australian Senate inquiry where women testified they felt like “guinea pigs” after their implants. At the same time, the largest class action in Australia, 700 women are suing Ethicon, a division of Johnson & Johnson, for defective mesh implants, both POP mesh and SUI mesh.
The class action trial began in July and is expected to take six months. See MND story here.
The founder of the Australian Pelvic Mesh Support Group, Caz Chisholm, told The Herald (here)that the problem has always been a lack of information to women considering an implant.
No woman that I know in the support group of more than 1000 women was told by her surgeon that her device was high risk, or medium to high risk,” Ms Chisholm said. “Once these devices are re-classified, are specialists going to tell women the device they are about to be implanted with is high risk? I don’t think so.”
Ms Chisholm has pushed for a Senate report due in late November. She slammed the TGA for “quietly announcing” the changes on its website after her group’s sustained criticism.
The U.S. FDA still classifies SUI mesh as moderate risk, despite the fact that it is a permanent implant. In January 2016, the FDA reclassified POP mesh as high risk but gave the manufacturers 30 months to prove its safety or stop marketing the devices. See MND story here. ###
https://www.meshmedicaldevicenewsdesk.com/mesh-high-risk-australia/
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Give us back the tools to repair pelvic prolapse in women
Oct 31, 2017 | Financial Review
By Jill Margo
Fed up with fighting the medical establishment over how to treat intimate female problems, a Sydney specialist has fired off a new book aimed directly at the women he believes are being denied a beneficial treatment.
The problem is prolapse which can cause pelvic heaviness, painful intercourse, bowel difficulties and, importantly, urinary incontinence.
Incontinence is one of the main reasons older women eventually land up in residential facilities.
The author is part of a small group of Australian surgeons who say they have a method to repair prolapse and, in particular, can successfully reverse incontinence in up to 85 per cent of cases.Confusion
The method, which has evolved over the past 15 years, is in established use in Germany, Japan and Turkey but is strongly opposed in Australia and involves a system of reinforcing ligaments in the pelvis with a medical tape.
Many in the medical establishment don't approve of the system or the tape.
They say the system is based on one of many theories about pelvic prolapse and that no one really knows what causes prolapse.
Further, they say the tape is a polypropylene mesh, a material that has become highly contentious in women's health in recent years.
But the group of surgeons say the evidence to show their system works is becoming overwhelming and no one is contesting the data.
They say mesh in sheet form, not in tape form, is causing the problems and that the two are used in completely different ways.
The group is highly frustrated that the two have been lumped together.
They say the tape has been tarred with the same brush as the sheet mesh.
In 2014 their tape was removed from the approved prosthesis list due to administrative issues.
This left them unable to perform the repair work and a battle to have the tape reinstated has been underway ever since.The book
The group is led by Dr Darren Gold, a British trained, Sydney based colorectal surgeon and secretary of the International Society of Pelviperineology.
His frustration with the withdrawal of the tape drove him to publish his e-book in which he passionately puts the case directly to women.
It's called Pelvic Flawed: a step-by-step guide to why women become incontinent, how they can be helped and why the cure is not being offered to them.
"I've risked everything to write this book. I've been knocking my head against a brick wall of government and medical professional intransigence for years, and I'm sick and tired of getting no response," he writes.
The book is easy to read and states its case in bold terms. Although repetitive in parts, it explains the repair process simply, provides personal stories from women, and presents the available scientific evidence.
It also details the battle with Australian authorities along the way including the Therapeutics Goods Administration, a Senate committee and the Administrative Appeals Tribunal.
Among the positive reviews on Amazon, one woman writes that after 36 years of hell, she's finally learnt there is a cure. "After reading Dr Gold's book l wasn't sure whether l wanted to cry or kill someone."
Gold describes the repair as "a breakthrough of unbelievable proportion".
"The history of medicine is replete with advances rendering current practices obsolete and I believe this repair will prove yet another example."
He just wants the tape back so he can continue the repair work.The repair method
Gold says the repair is the brainchild of an Australian professor of Gynaecology, Peter Petros, who has been quoted more than 4000 times in medical literature.
It's based on his "Integral theory" that all organs in the female pelvis – the uterus, bladder, vagina and rectum – are interrelated and should be regarded structurally as an integrated whole.
Five suspensory ligaments hold these organs in place and in conjunction with muscles ensure the pelvis functions smoothly.
But with age, wear and tear, childbirth, injury or strain, different ligaments can be over-stretched and become lax.
Unlike muscles, they can't be exercised back into shape.
So the surgeons do an operation that reinforces them with tape.
The tape causes the ligaments to scar. Over time, the tape becomes covered with collagen scar tissue which further strengthens the ligaments.
Provided the tape is anchored securely along the natural line of the ligament and not in muscle, bone or an organ, Gold says the organs retain their natural elasticity and resume normal function.The tape
While mesh has been used globally for 40 years to repair inguinal and other hernias, there is alarm about its use in the female pelvis.
A class action has been commenced against the manufacturing giant Johnson & Johnson by 450 Australian women who claim to have been permanently harmed by sheet mesh.
And more than 300 have joined a class action against another American device manufacturer.
Gold is leading the fight to distinguish the use of the tape from the use of sheet mesh in women.
"Where you put the tape is of fundamental importance," he says.
"Mesh initiates scar tissue and if you put it in contact with an organ or around an organ itself, scarring can create rigidity which has the potential to be disastrous."
"The pelvis has zones of elasticity that must never be compromised because, to function well, these organs need to retain their elasticity."
Rigidity can be painful and, in a small number of women, he says tissue can be eroded – like grated cheese – and the mesh exposed.
With the Integral theory, the tapes don't contact organs. They strengthen the ligaments and preserve organ elasticity.
Gold says a single errant gynaecologist working in NSW did not follow the theory's protocol, placed the tapes incorrectly and used other implants, causing unnecessary scarring and several problems for women.
His actions muddied the waters and resulted in the tape being condemned along with sheet mesh.Two kinds of incontinence
Women suffer two kinds of urinary incontinence. Stress incontinence occurs when they laugh, sneeze, cough, jump or do anything that puts pressure on the bladder.
In the '90s Petros developed a method of treating this condition using tape.
Called the mid-urethral sling, his method proved highly successful and has now become the world gold-standard for treating stress incontinence.
Gold says the problem arose because people thought if mesh work for this, it will work for other types of prolapse and they began placing sheets of mesh alongside and around pelvic organs.
He says this was done without reference to the Integral theory and for many women was disastrous.
Petros, however, went on to use his Integral theory to treat the other kind of incontinence – urge incontinence – for which no durable treatment exists.
Often described as an unstable or overactive bladder, urge incontinence is a sudden need to urinate that is so strong many women can't hold on.
In his book, Gold says while the medical establishment was delighted to adopt Petros' mid-urethral sling, it won't accept the rest of his work and it has so far been unable to invalidate the data.
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists declined to comment.
Last week the TGA announced all pelvic mesh devices on the Australian market are to be classified high risk.
* Jill Margo is an associate adjunct professor at the University of NSW.
http://www.afr.com/lifestyle/health/womens-health/give-us-back-the-tools-to-repair-pelvic-prolapse-in-women-20171030-gzb3h6 -
Scandal of the implant prolift : Should We Be Concerned About In France ?
Oct 31, 2017 | The Stopru
Pain permanent, inability to walk or having sex with thousands of women around the world say they are victims of a denture of French origin. Used to treat the descent of the organs (or organ prolapse) and incontinence after childbirth, the implant Prolift can be split into the vagina and cause discomfort to severe, as has denounced the Obs in a recent survey. But in France, does it matter to alert ?
PROLIFT, A VAGINAL IMPLANT IS ACCUSED BY THOUSANDS OF PATIENTS SUFFERING
Prolift was introduced to the market in march 2005 by the laboratory, Johnson & Johnson, and developed by a French team. Installed as a mesh through the vagina, it has the function of preventing the descents of organs and treat incontinence treated post-childbirth.
The complainants made were Australian, American, English, Scottish or Néérlandaises. Victims of serious side effects, they complain heavily against the lab Johnson & Johnson. Too heavy and poorly positioned, the prosthesis may in fact take years to cut into the vagina or perforate the rectum or the bladder.
Beyond the pain, patients wished to complain of the lack of prior information. These women feel they do not have given informed consent to this operation. “The only risk I was informed before my surgery were that it would not may not be, which is completely different from having to live each day in pain,” said a patient via Mesh Down Under, a group of victims néozélandaises.
The lack of training of health professionals is also being put in question by the patients who report a diagnosis difficult and surgeons are reluctant to re-operate. “It took me four years and six different specialists to get a diagnosis”, told in 2016 Mrs Sullivan, new zealand established in 2008.NOT PROLIFT IN FRANCE, BUT PROSTHESES ARE SIMILAR TO THE RISKS ARE KNOWN AND MONITORED
In France it is in 2013 (a year after the United States) that the marketing of the Prolift and 3 other medical devices that are similar is stopped “by a decision of the lab for economic reasons,” says the MAN. In other words, this case is not attributed to the adverse effects of the device.
If Prolift is no longer marketed in us, the other prostheses like, which are subject to monitoring and recommendations for use specific. Thus, in June 2016, the Boston Scientific Group, a manufacturer of several prostheses of reinforcement, had to add adverse effects in the records of several of its products on the request of the authorities, including “pain standing” or “perforations or lacerations of vessels, nerves, bladder, urethra or intestine”. For its part, the MSNA is currently carrying out a control of the market on this type of device, and is funding a study to report and analyze the complications and serious adverse events related to surgery for stress urinary incontinence and pelvic organ Prolapse.
If, however, the Prolift is no longer available to us, the prosthesis was still in use fairly recently for some patients the French are concerned. In addition, other prostheses of the same type are currently being marketed and used in France. Why does it therefore not of judicial movement on the part of patients implanted ? According to experts, information and listening to patients and good medical practices would be the key to optimal management.
IN FRANCE, THE IMPLANT REINFORCEMENT BY VAGINAL DELIVERY IS RECOMMENDED ONLY AS A LAST RESORT
Practitioners French follow specific recommendations. To treat the prolapse, the High Authority for Health (HAS) recommends that you first re-education to stabilize the development or use of a pessary (flexible ring placed in the vagina) for patients at very high surgical risk or who refuse surgery. However, the pessaries which have high risks of infections, the treatment remains essentially surgical : either with the tissue existing (historic technique involving significant risks of recurrence), either by the installation of prostheses, which can expose them to other types of complications, including erosions and infections. These options allow you to “adapt the treatment to the patient,” says Dr. Nicolas Korahanis, surgeon urologist at the university of Montpellier.
According to the French Association of Urology (AFU) the surgery of reference for installing the implants is done through the abdomen rather than vaginally. “This surgery has been concerned with 20.000 patients in 2016 and gives excellent results”, says Dr Christian Castagnola, surgeon, urologist and Vice-President of the AFU delegate to the communication, “We get very few complications, with only 3.4 % of erosions, and which are treatable”.
On the other hand, in the case where the way abdominal is not recommended, for example because the patient has suffered too many interventions by this or if it can’t withstand general anesthesia, the vagina remains a more risky, but possible. “The success of this operation primarily depends on a correct indication and a precise technique,” says Dr. Christian Castagnola. “It is a surgery more delicate, with a rate of erosion of the prosthesis, which can reach 12 % and up to 60 % of dyspareunies (pain during inflow sexual)”. If these adverse effects are reported, it is necessary to remove all the material at a “surgery complicated”, with no guarantee that the pain will disappear. “All treatments have side effects”, said Dr. Nicolas Korahanis. “Even if he has had many complications on some hearing aids, thousands of women have also been cured by these techniques”.
INFORMATION AND LISTENING TO THE PATIENT, THE PILLARS OF INFORMED CONSENT
“To manage a complication is not easy, but the dialogue remains the best solution. It took me sometimes réopérer the patients, but with good information it never became a problem,” says Dr Nicolas Korahanis, which described the surgery as”a school for humility”, in which “one learns until his retirement”.
On the side of gynecologists, the other specialties involved in this type of surgery, the recommendations go in the same direction in terms of communication, although they do not show preference between the surgeries through the abdomen and vagina. They stipulate that patients should be informed of the alternatives to surgery in general (pessary, rehabilitation) and prosthetic surgery in particular, but also complications related to the surgery of prolapse, inherent to the surgical approach is vaginal or abdominal”.
“The most important thing is to inform and listen to the patients before and after surgery with regular follow-up,” adds Dr. Castagnola, to the effect that the EBA recommends to give systematically explanatory records to patients, in addition to the dialogue at the firm. The rules of professional conduct, which could explain the absence of a judicial movement on the part of the patients French who have poorly tolerated the implant reinforcement. “It always comes back to the dialogue with the patients,” he concludes, “and do not forget that the suffering of these women must always be taken into account”.
https://stopru.org/scandal-of-the-implant-prolift-should-we-be-concerned-about-in-france/2959
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