Preview Newsletter
Ethicon Media Monitoring 7/5/2018
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AUGS Breaks with the Father of Gynecology
Jul 4, 2018 | Mesh Medical Device News Desk
By Jane Akre
Twelve years after a portrait was removed from the University of Alabama of a controversial figure in modern gynecology, the medical society has decided to part ways with Dr. J. Marion Sims. -
Mesh implant complications leave some women feeling suicidal, pain management expert warns
Jul 4, 2018 | Cambs Times
By Kath Sansom
Andrew Baranowski, of the British Pain Society, says it is a basic human right for these women to have good quality pain management, yet there are probably only five centres in the UK which can deal with such complex problems. -
UK's top surgeon calls for new procedures to undergo clinical trials
Jul 5, 2018 | The Guardian
By Hannah Devlin
Britain’s most eminent surgeon has called for new surgical procedures and implants to be tested in clinical trials before being made routinely available on the NHS.
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AUGS Breaks with the Father of Gynecology
Jul 4, 2018 | Mesh Medical Device News Desk
By Jane Akre
Twelve years after a portrait was removed from the University of Alabama of a controversial figure in modern gynecology, the medical society has decided to part ways with Dr. J. Marion Sims.
AUGS. The American Urogynecologic Society is the lead medical society responsible for the promotion of polypropylene mesh (PP) implants.
Most recently, in response to a recent 60 Minutes segment on some rather questionable behavior by Boston Scientific, AUGS issued a reasonable sounding statement on its website that it is neither “Pro – Mesh nor Anti – Mesh. AUGS is Pro-Science!”
Good to know.
It was science, ethics and pressure among the 1,900 members that caused AUGS, in November 2017, to make a radical departure from past behavior.
The medical society decided to retire its annual keynote speech, the J. Marion Sims Lectureship at Pelvic Floors Disorder Week, after a presentation the month before by Dr. Lewis Wall.
J MARION SIMS, MD
Dr. Sims is known as the father of modern gynecology because in the mid 1800’s, he perfected the treatment of fistulas and creation of the modern tools used in gynecologic procedures.
The problem is that Dr. Sims perfected his surgical techniques by operating on enslaved black women. He didn’t use anesthesia, it was believed they did not experience the same level of pain as white women.
Anesthesia was just coming into its own between 1846 and 1849, when Dr. Sims performed multiple surgeries on at least ten slave women. There was no informed consent. The slave women often carried babies that were the result of rape, and those babies could be taken from them. Their bodies were not their own to be able to direct. They were powerless.
The women, undergoing the experimental surgery, were naked, as one portrait shows. They would be held down, either by other doctors in attendance or by other slave women.
The women reportedly wanted to be rid of fistulas, the result of a difficult birth where an infant becomes lodged during the birth process.
Dr. Sims’ first three fistula patients were Lucy, Anarcha, and Betsey.
Lucy was 18 when she underwent an operation at the hands of Dr. Sims. She had given birth a few months prior and now had incontinence.
Lucy was on her hands and knees with her head rested on her hands. She screams in pain, and Sims wrote “Lucy’s agony was extreme.” She also contracted blood poisoning from his use of a sponge to drain the urine. It took her months to recover.
Anarcha, 17, a slave, had a traumatic labor and delivery and underwent 30 operations, without anesthesia. Dr. Sims perfected his method on Anarcha, then later in 1855 he moved to New York and opened Women’s Hospital, the first of its kind, where he performed surgery on white patients.
The medical society decided to retire its lectureship in the name of Dr. Sims because the members were “no longer unified in our views, and it now serves primarily as a source of polarization, pain, and disenfranchisement.”
Then AUGS President, Halina M. Zyczynski, MD, wrote, “We are sensitive to the perspective that the named lecture implies honor to a man whose treatment of vulnerable women has been determined to be strongly suspect.”
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The controversy is not new.
Twelve years earlier, a portrait of Dr. Sims had been removed from the University of Alabama’s Center for Advanced Medical Studies.
After medical training in 1813, which involved interning with a physician, taking a three-month course, and then studying for a year at Jefferson Medical College, Dr. Sims practiced in Lancaster Co. SC, but his first two patients died and he moved to Montgomery, Alabama.
Meanwhile a statute of Sims still stands in Alabama. Removing it is not possible under the Alabama Memorial Preservation Act of 2017. A monument to Sims near the South Carolina Statehouse near Columbia, S.C. remains in place.
On April 17, 2018, a statute of Dr. Sims in New York City was removed from its Central Park location and relocated to Greenwood Cemetery in Brooklyn. The move came after years of protests by community activists who had gathered more than 26,000 signatures, which were brought to the attention of city officials. Mayor Bill de Blasio agreed to the relocation.
While medical scholars and bioethicists argue over Dr. Sims, another option has been proposed.
In a 1941 paper titled “The Negro’s Contribution to Surgery,” published in the Journal of the National Medical Association, Dr. John A. Kenney of the Tuskegee Institute, considered the dean of black dermatology, wrote,
“I suggest that a monument be raised and dedicated to the nameless Negroes who have contributed so much to surgery by the ‘guinea pig’ route.”
Kenney was referring to Lucy, Anarcha and Betsey, whose stories have been erased from history.
LEWIS WALL MD
The Keynote speech that caused the change in direction for AUGS, Vesico-Vaginal Fistula: Historical Understanding, Medical Ethics, and Modern Sensibilities, was delivered by Dr. Lewis Wall, an obstetrician and gynecologist with a doctoral degree in social anthropology and masters in biotethics.
He founded the Worldwide Fistula Fund and has a fistula center in Niger, consults to the International Fistula Alliance and has written, Tears for my Systers: The Tragedy of Obstetric Fistula.”
He works with a Ugandan NGO, Terrewolde, as well as Danja Fistula Center in Niger.
In an interview (here) with PFD Week, Dr. Wall said he has long been interested in medical ethics and in fistulas. He has traveled extensively throughout Africa to treat women with fistulas.
An estimated 4 million African women have a vesico-vaginal fistula, a result of a difficult childbirth in areas of the world where cesarean section is not available. In those cases, labor may last for days and in the process, the tissues that separate the bladder from the vagina can be destroyed.
Women who suffer this injury may become totally incontinent. In some societies that means they are outcasts.
https://www.meshmedicaldevicenewsdesk.com/augs-breaks-with-the-father-of-gynecology/
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Mesh implant complications leave some women feeling suicidal, pain management expert warns
Jul 4, 2018 | Cambs Times
By Kath Sansom
Andrew Baranowski, of the British Pain Society, says it is a basic human right for these women to have good quality pain management, yet there are probably only five centres in the UK which can deal with such complex problems.
Mr Baranowski said: “Put simply living with chronic pelvic pain is associated with a significant negative effect on mood, thoughts, behaviour, sexual and personal relations as well as employment.
“It increases the risk of depression and anxiety and is associated with increased suicidal risk as well as mortality from other conditions like cardiac problems.
“Access to pain management is a fundamental human right. Despite this there are only probably five specialised pelvic pain management services in England that would meet NHS specifications to provide specialist assessment and management of conditions.
“There are limited NHS resources for those that live with chronic pelvic pain. Many medics struggle to know how best to support and manage those living with it.”
Mr Baranowski, who attended the latest Mesh All Party Parliamentary Group, led by MP Owen Smith, added: “As well as the psychological responses of living with chronic pelvic pain these women live with the anger of what has happened to them, the frustration and emotions of not being believed and the distress associated with traumatic stress of what they have been through (PTSD).
“It is well established that traumatic emotions will increase the pain experience and that the pain will increase psychological traumatic experiences.
“Living with chronic pelvic pain following mesh insertion is well established. Whereas, how often it happens is not well recorded.”
“When it does happen it is clear that the pain can be intrusive to the extent that some consider suicide.”
“The complex journey these individuals follow post surgery will usually be associated with significant distress, depression, anger, and negative thoughts; as well as severely reduced physical and sexual activity, a negative impact on relationships and difficulty with maintaining employment.”
“There is limited published data on the incidence of chronic pain after mesh surgery but there is evidence it does occur and could be around 40 per cent of those with complications post mesh, if not higher.”
Mr Baranowski said there now needs to be proper pathways of care set in stone in NHS guidelines.
“Care should be in dedicated centres with specialist teams,” he said. “Including surgeons, colorectal physicians, pain physicians and teams of specialised nurses, psychologists and pain physiotherapists.
“Complex imaging and assessment is key. In certain cases, psychiatric support may be required.
“Specific guidelines need to be agreed. This will require NICE and NHS England Specialised Services working closely with the Royal Colleges and specialist Societies, such as The British Pain Society. There needs to be a plan for commissioning of such services.”
http://www.cambstimes.co.uk/news/andrew-baranowski-mesh-pain-appg-pelvic-1-5591445
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UK's top surgeon calls for new procedures to undergo clinical trials
Jul 5, 2018 | The Guardian
By Hannah Devlin
Britain’s most eminent surgeon has called for new surgical procedures and implants to be tested in clinical trials before being made routinely available on the NHS.
Prof Derek Alderson, the president of the Royal College of Surgeons, said the benefits of surgical innovations must “absolutely, unequivocally” be backed by evidence, either through randomised controlled trials or official registries designed to track patient outcomes. The move would bring surgical innovation more closely in line with the way new drugs are introduced.
New surgical techniques and devices are frequently rolled out with no clinical trial and no long-term follow-up, making it difficult to objectively assess benefits to patients or whether complication rates are acceptable. Alderson said this traditional model was not fit for modern surgery.
“If there is to be a new treatment, we need to prove that it’s been tested in a reasonable way before it is widely applied,” he said.
The failure to carry out clinical trialsor collect long-term postoperative data may have contributed to the metal-on-metal hip and vaginal mesh scandals, in which thousands of patients have suffered serious complications. “You can’t say that’s the sole driver, but it is one of the things that’s raised awareness, there’s no doubt about that,” said Alderson.
The first ever randomised controlled trials were led by the British Medical Research Council innovation, in 1948, to assess a tuberculosis drug, and such trials are legally required for the licensing of new medicines. Until recently many had argued that requiring the same standards of evidence for surgery was impractical – the range of expertise across doctors and the learning curve associated with the introduction of a new operation complicate things.Guardian Today: the headlines, the analysis, the debate - sent direct to you
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However, Alderson said the profession was prepared to rise to the challenge, noting that three years ago there were just 80 surgical trials under way in NHS hospitals, while this year there are about 300.
“We have to accept that society evolves, people’s attitudes evolve and we must find better ways of finding evidence,” he said. If there are ethical issues that make it difficult to conduct a full trial, he said, then the aim should be to seek patient consent for their data to be kept in a secure, anonymised registry.
In particular, Alderson said, the increasing number of people undergoing surgeries aimed at improving quality of life rather than as life-saving treatment, means risks associated with surgery have to be considered more critically.
“In the past, older people had a more fatalistic approach about surgery because it was more risky,” he said. “Now we know how to make surgery safe for the very elderly.”
Prof Andy Carr, the director of the Nuffield Orthopaedic Centre, Oxford University Hospitals NHS trust, has led a series of UK-wide trials of surgery, including a recent Lancet study showing that a common shoulder surgery is no more effective than a sham version of the same operation, where incisions are made, but the procedure is not carried out.
Previous sham surgery trials by other teams have revealed no meaningful benefits beyond placebo for arthritic knee surgery, spinal cement injections for vertebral fractures, some gastric balloon procedures for obesity and certain forms of endometriosis surgery. This does not mean that patients’ condition does not improve – the placebo effect can be powerful, particularly when treating subjective conditions such as pain, stiffness or impulse control. But surgery is expensive and the risks can be considerable, raising questions about how many elective operations might be unjustifiable if scrutinised more closely.
“Is the evaluation of surgery fit for purpose? I personally don’t think it is in a number of areas and we could and should be doing better,” said Carr.
He welcomed the increase in the number of trials, but said evidence-based surgery remained the exception, not the norm.
“If you go into a cancer clinic you’d expect a significant number of patients to be in some sort of study,” he said. “In a surgical clinic it’s less than 1%. There’s a whole structural healthcare environment that’s not really fit for purpose.”
According to Carr, surgery has retained a “battlefield” culture of “giving it a go”, that is no longer appropriate for the modern NHS where a majority of patients are having operations to improve their life, not to save it.
“The regulatory environment for new technologies is based in a previous era when it was just accepted that you gave it a go and saw what happened – procedures like heart transplants,” Carr said. “We don’t think that’s appropriate for the modern age.”
However, Alderson disputed this stereotype, saying that most surgeons, including consultants, were now accountable to multidisciplinary teams.
“We really shouldn’t perpetuate a myth that this is still the norm in surgery,” he said. “It certainly is not the way most surgeons view their careers nowadays.”
https://www.theguardian.com/society/2018/jul/05/uks-top-surgeon-calls-new-procedures-undergo-clinical-trials
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