Preview Newsletter
Ethicon Media Monitoring 1/24/2019
-
Mesh expert failed to declare £100,000 funding
Jan 23, 2019 | BBC News
By Lucy Adams
A high-profile academic has admitted he failed to declare £100,000 from the manufacturer making one of the types of vaginal mesh implant he was assessing. -
Mesh implant makers gave professor ‘secret funding’
Jan 24, 2019 | The Times
By Elizabeth Burden
An academic has admitted secretly receiving £100,000 of funding from the manufacturer of a vaginal mesh implant, the side-effects of which he was studying after hundreds of thousands of women reported complications. -
Johnson & Johnson: From baby talcum powder to cutting-edge surgical robotics
Jan 23, 2019 | Verdict
By Priya Kantaria
...In spite of this progress, J&J is surrounded in controversy over its vaginal reconstructive mesh and claims that its famous baby talcum-powder products have caused cancer. -
UTA researcher earns grant to detect, repair vaginal prolapse in early stages
Jan 23, 2019 | UTA News
By Jeremy Agor
A team of bioengineers at The University of Texas at Arlington is working to develop a method that will allow physicians to repair vaginal prolapses while they are in their early stages, potentially avoiding surgery and other complications. -
Vaginal Mesh Causes Health Problems In Many Women
Jan 23, 2019 | Washington Post (In Doctor NDTV)
By Susan Berger
Regina Stepherson needed surgery for rectocele, a prolapse of the wall between the rectum and the vagina. Her surgeons said that her bladder also needed to be lifted and did so with vaginal mesh, a surgical mesh used to reinforce the bladder.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Mesh expert failed to declare £100,000 funding
Jan 23, 2019 | BBC News
By Lucy Adams
A high-profile academic has admitted he failed to declare £100,000 from the manufacturer making one of the types of vaginal mesh implant he was assessing.
Aberdeen University's Prof Mohamed Abdel-fattah has published a correction to his original research paper almost seven years on.
The change follows a complaint to the General Medical Council about him.
The doctor who made the complaint said it was "shocking" the funding had not been declared at the time.
Prof Abdel-fattah denied that there was any link between the funding and the study.
Mesh implants are used by surgeons to treat conditions which some women suffer after childbirth.
The synthetic mesh is used to repair damaged or weakened tissue in the woman's body.
Many women have been left suffering chronic pain following the surgery.
Tens of thousands of women across the UK have been given them over the past 20 years.
However, the use of mesh in Scotland was suspended in all but "exceptional circumstances" in 2014 after it emerged some women had suffered painful side-effects.
Prof Abdel-fattah was the lead clinician on a 2012 study that concluded that no patients were suffering thigh pain three years after their surgery.
His study had compared two types of "transobturator" mesh tapes.
In his original declaration Prof Abdel-fattah said funding, about £65,000, came from The Henry Smith Charity - but he did not mention the £100,000 received from the manufacturer of one of the devices used in the study, Coloplast.
Figures show around 40,000 women across the UK have had the transobturator mesh procedure.
It was the most commonly performed bladder surgery in Scotland and is also used in England.
A complaint was made to the GMC in 2018 with allegations of research misconduct at various levels.
Prof Abdel-fattah has now published a correction to his 2012 report admitting funding from the manufacturer but denied any link to "any aspect of the study at any time from design to publication".
He said the research grant from Coloplast was "inadvertently omitted" from the original disclosure.
The correction also contains a link to Prof Abdel-fattah's own declaration of interests. These include receiving money from a number of mesh manufacturers for being a consultant and trainer for mesh manufacturers including Ethicon and Coloplast.What is vaginal mesh?
It is an implant used to treat incontinence and repair pelvic organ prolapse.
The mesh - which can be synthetic or biological - can support the vaginal wall or internal organs.How many women have had the implants?
It is estimated more than 100,000 women have had a mesh fitted in the UK.
About 27,000 were in the past 10 years - but 211 women have had it removed.
Why are some women angry?
Some say the implant has caused them severe pain by cutting into internal tissue.
More than 800 women are taking legal action against the NHS and mesh manufacturers over the mesh.
However, the vast majority have suffered no side-effects.
What do health bosses say?
In Scotland, health boards were ordered to stop the use of implants last year.
Health guidelines in England say women should only be offered mesh surgery as a last resort, or for research purposes.
What are the alternatives to mesh?
Physiotherapy and traditional surgery are also an option, depending on the severity of the problem.
'Highly influential'
Dr Wael Agur, a consultant urogynaecologist and expert in mesh, made the original complaint to the GMC.
He said Prof Abdel-fattah's study was "highly influential".
Dr Agur said it was "shocking" that the funding from Coloplast had not been declared at the time.
He said: "This study had reassured us seven years ago that the use of mesh is safe - so we continued using it.
"Now we find out that the researchers had received £100,000 from the mesh manufacturers. Why was this money never declared at the time?
"The women trusted us to do the right thing and we thought at the time that we were doing the right thing."
'Life ruined by mesh'
Lorna Farrell had transobturator mesh fitted in 2008.
She says she now lives in constant pain and uses a wheelchair to get about.
She says her life has been "ruined" by mesh.
Lorna told BBC Scotland: "We need to have research into it but how can it be that the research is part-funded by the manufacturers?
"If they want to fund research why don't they speak to those who have been damaged by what they have done."
Restricted use
The GMC said it could not comment on individual cases.
But the BBC understands a failure to declare funding from a pharmaceutical company in a research study could potentially raise an allegation about the fitness to practise of a doctor.
A statement from Aberdeen University said: "Prof Abdel-fattah has been informed by the GMC that they looked into a complaint made against him but the investigation has now been closed as of December 2018.
"Neither Prof Abdel-fattah nor the university are aware of any further ongoing investigation."
The statement added: "The GMC did not ask him to make the amendment to the paper, he did so of his own volition in the interests of increased transparency.
"The amendment clearly stated that Coloplast had no input to the study in any form and at any stage."
The university pointed out that transobturator tapes had been the most common procedure of this sort worldwide since at least 2009.
The use of mesh in Scotland has been controversial.
It has been used hundreds of times since the partial suspension in 2014.
Last year, transabdominal mesh was cited as an underlying factor in the death of a Scottish woman and the Scottish government called for an immediate halt to its use until a new "restricted use protocol" is drawn up.
NHS England has also recently curbed the use of mesh on safety grounds, although it is still available as a treatment of last resort for some.
https://www.bbc.com/news/uk-scotland-46972350
-
Mesh implant makers gave professor ‘secret funding’
Jan 24, 2019 | The Times
By Elizabeth Burden
An academic has admitted secretly receiving £100,000 of funding from the manufacturer of a vaginal mesh implant, the side-effects of which he was studying after hundreds of thousands of women reported complications.
Mohamed Abdel-Fattah, a gynaecology professor at the University of Aberdeen, issued a voluntary correction to his original research almost seven years after it was published, following a complaint to the General Medical Council (GMC) — although he denied any link between the funding and the study.
Mesh implants are used to mend tissue in some women after childbirth, which can lead to incontinence when they cough, sneeze or have sex.
After it was revealed that some women were suffering chronic, painful side-effects, the implants were suspended in all but “exceptional circumstances” in Scotland…
Access to full text unavailable – subscription required.
Story can be found here: https://www.thetimes.co.uk/article/mesh-implant-makers-gave-professor-secret-funding-9r9cd6g6v
-
Johnson & Johnson: From baby talcum powder to cutting-edge surgical robotics
Jan 23, 2019 | Verdict
By Priya Kantaria
Healthcare company Johnson & Johnson is in talks regarding the potential acquisition of an American medical robotics company that will bring in leading surgical robotics technology, reports Bloomberg.
The move to take control of Auris Health’s cutting-edge surgical robotics is the latest in a string of partnerships and acquisitions by J&J within the growing market of surgical robotics.
Auris Health will bring robotic surgical scopes that operate by a handheld controller and use flexible tubes that are directed into a patient’s lungs and can help identify cancerous tumours.UK’s NHS “urged to embrace full automation”
In June 2018, the UK’s National Health Service was urged to embrace full automation, including bedside robots and AI diagnoses.
The recommendations were made by the former UK health minister and a leading surgeon Lord Darzi.
His report said this would free up frontline staff with associated costs of up to £12.5bn a year – 10% of the annual running costs.
“Given the scale of productivity savings required in health and care – and the shortage of frontline staff – automation presents a significant opportunity to improve both the efficiency and the quality of care in the NHS,” he wrote.
The report released by think tank IPPR also pre-empted Johnson & Johnson’s interest in Auris Health, suggesting increased use of robots in surgery.The growing surgical robotics market
Accuray Research said the robot-assisted minimal access surgery market is estimated to reach $20bn by 2025.
And GlobalData Healthcare reported in 2018 that medical device companies have turned to surgical robotics as the next big innovation.
Surgical robotics are designed to solve limitations in minimally invasive surgeries as well as improve open surgical procedures.
Intuitive Surgical led the way in the global surgical robotics market, with competitors including J&J, Stryker and Medtronic, which closed on the acquisition of Israeli Mazor Robotics in December 2018.
These players are partnering with or acquiring surgical robotics companies to push ahead in the medical robotics space.J&J’s progress tempered by controversy
In September 2018, Verdict Medical Devices reported how J&J acquired Emerging Implant Technologies, the German manufacturer of 3D-printed titanium interbody implants for spinal fusion surgery.
In 2015, J&J partnered with Alphabet’s medical arm to develop robotic-assisted tools for surgeons, reported by Reuters.
In spite of this progress, J&J is surrounded in controversy over its vaginal reconstructive mesh and claims that its famous baby talcum-powder products have caused cancer.
Today, Verdict Medical Devices reported that J&J agreed to settle on claims of unfair promotion of longevity of its hip implants.
https://www.verdict.co.uk/johnson-johnson-baby-talcum-powder-cutting-edge-surgical-robotics/
-
UTA researcher earns grant to detect, repair vaginal prolapse in early stages
Jan 23, 2019 | UTA News
By Jeremy Agor
A team of bioengineers at The University of Texas at Arlington is working to develop a method that will allow physicians to repair vaginal prolapses while they are in their early stages, potentially avoiding surgery and other complications.
Yi Hong, an associate professor in UTA’s Bioengineering Department, is leading an interdisciplinary team that will use a five-year, $1.9 million grant from the National Institutes of Health to develop a new method of treating a vaginal prolapse before the vagina completely detaches, which could prevent complications and improve the quality of life of thousands of women.
Hong’s UTA colleagues Kytai Nguyen, Liping Tang and Jun Liao, along with UT Southwestern urologist Phillippe Zimmern are co-principal investigators on the project.
Vaginal prolapse is a condition affecting almost 3 percent of U.S. women, according to the Office on Women’s Health. In a prolapse, the pelvic floor muscles weaken and tear, allowing the vagina to stretch or expand and protrude on surrounding organs and structures. Treatment usually involves surgical implantation of mesh to repair the muscles, but the mesh often leads to severe complications that require extended recovery time and cause discomfort.
Hong and his team are developing a strong, bioactive bioadhesive that is strong and bioactive to reattach the pelvic floor muscles early, before they detach completely, and stop further tearing while the body repairs the affected muscles.
“A lot of women suffer from vaginal prolapse and it really affects their quality of life. Hopefully, our research will help women and ease their discomfort,” Hong said.
“It is difficult to repair a full muscle tear, but if a prolapse is detected early, we can glue the two edges together while they are still partially attached and prevent further damage. Because it is bioactive, the adhesive will allow the body to rejuvenate naturally, and there will be far less discomfort for the patient.”
Hong’s research is an example of health and the human condition, one of four themes of UTA’s Strategic Plan 2020, and of the ways that the University is making an impact on the community, said Michael Cho, chair of the Bioengineering Department.
“This is a condition that affects women of all ages, and Dr. Hong and his team have a chance to make its treatment easier and less intrusive for those women. His ability to apply knowledge and techniques from previous research, as well as the strengths from the interdisciplinary team of investigators, will lead to success,” Cho said.
The Bioengineering Department has served North Texas for more than 40 years, with research strengths in bioinstrumentation, biomaterials and tissue engineering, biomechanics, medical imaging and nanomedicine/nanotechnology. The program was ranked No. 96 in the 2019 U.S. News & World Report graduate rankings. UTA offers a joint program with UT Southwestern, one of the top medical schools in the country, and students can take courses and conduct research at either campus. UTA researchers have labs in UTSW’s Bill and Rita Clements Advanced Medical Imaging Building for work on medical imaging projects. An undergraduate program was added in 2012. In 2017, the department won a National Institutes of Health T-32 grant to subsidize and train doctoral students in healthcare applications for nanotechnology, specifically to develop tools to battle cardiovascular and pulmonary ailments.
https://www.uta.edu/news/releases/2019/01/Yi-Hong-NIH-vaginal-prolapse.php
-
Vaginal Mesh Causes Health Problems In Many Women
Jan 23, 2019 | Washington Post (In Doctor NDTV)
By Susan Berger
Regina Stepherson needed surgery for rectocele, a prolapse of the wall between the rectum and the vagina. Her surgeons said that her bladder also needed to be lifted and did so with vaginal mesh, a surgical mesh used to reinforce the bladder.
Following the surgery in 2010, Stepherson, then 48, said she suffered debilitating symptoms for two years. An active woman who rode horses, Stepherson had constant pain, trouble walking, fevers off and on, weight loss, nausea and lethargy after the surgery. She spent days sitting on the couch, she said.
In August 2012, Stepherson and her daughter saw an ad relating to vaginal mesh that mentioned 10 symptoms and said that if you had them, to call a lawyer.
"My daughter said, 'Oh Mom - you have every one of those,' " Stepherson, of Tyler, Texas, recalled.
Vaginal mesh, used to repair and improve weakened pelvic tissues, is implanted in the vaginal wall. Initially, in 1998, it was thought to be a safe and easy solution for women suffering from stress urinary incontinence.
But over time, complications were reported, including chronic inflammation, and mesh that shrinks and becomes encased in scar tissue, causing pain, infection and protrusion through the vaginal wall.
Katrina Spradley, then 49, was about to have a hysterectomy in April 2008. She said that she told her physician that she also had urinary issues - every time she would laugh, cough or sneeze, she would leak urine. It happened so often that she wore sanitary pads. A urologist determined that implanting vaginal mesh at the same time as the hysterectomy would repair her bladder problem, she said.
Spradley, of Dawson, Georgia, also had endometriosis, a condition resulting from the appearance of endometrial tissue outside the uterus that most commonly causes pain (painful periods, heavy bleeding, pain with sexual intercourse). She thought that was the reason she began having stomach cramps after the surgery, she said, and physicians told her nothing was wrong.
In 2011, a urine test she took for her truck-driving license showed blood. Later, while having sex with her husband, his penis got scratched. It took a visit to a physician with her husband to detail his discomfort to find mesh eroding through Spradley's vagina, she said.
Chrissy Brajcic, a Canadian who struggled for four years with persistent infections following a mesh implant, became the face of mesh victims with a Facebook page. Brajcic died in December 2017 from sepsis at 42.
About 3 million to 4 million women worldwide have had mesh implanted to treat urinary incontinence and prolapse, said Shlomo Raz, professor of urology and pelvic reconstruction at UCLA school of medicine. About 5 percent - or 150,000 to 200,000 - of those have complications, he said.
"But when you have complications, it's hard to treat," Raz said.
Among the complications: chronic pelvic pain, erosion of mesh into the vagina, incontinence, obstruction, pain in the groin, hip and leg, and pain during intercourse. Raz also believes, based on his experience, that 20 to 30 percent of the complications are what he calls "lupus-type," causing runny nose, muscle pain, fogginess and lethargy. He bases this on the fact that, after removal, the patients are cured of these complications.
"If you remove mesh, and lupus-type symptoms disappear, the mesh is responsible," Raz said.
Michael Thomas Margolis, assistant clinical professor at UCLA, has removed more than 600 mesh slings in patients since 1998. He has served as an expert witness on polypropylene mesh in lawsuits for plaintiffs and most recently for lawsuits filed by the states of Washington and California.
"I have never implanted through a woman's vagina a polypropylene mesh or sling system ever, because of the complications," Margolis said. "I had concerns when they first came out - but my concerns were the tip of the iceberg."
Once the damage is done, it cannot be corrected, Margolis said.
The American Urogynecologic Society (AUGS) and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) support the use of polypropylene slings for stress incontinence. Their joint statement says that "Polypropylene material is safe and effective as a surgical implant."
Raz and Margolis disagreed. Raz, who said that many of the AUGS physicians who wrote the positive position statement were his fellows, said: "I don't agree based on my experience. I found that in the long run, we have created a monster, planting mesh in young women - some of them you can never cure."
Margolis said that many of the authors of the AUGS and SUFU joint position statement "receive substantial money from mesh manufacturers." He also said: "I have been a giant thorn in AUGS's side. They should at least acknowledge their financial conflict of interest."
According to the AUGS board of directors website, some of the directors do have financial interests in companies that make mesh.
Dionysios Veronikis, director of female pelvic medicine and reconstructive surgery at Mercy Hospital St. Louis, who has removed 250 to 300 mesh slings a year, said that problems result when a mesh is not implanted properly. He also said that women need to see a surgeon who does many of these surgeries. Their patients have fewer complications, Veronikis claimed.
He also said that "some of the [mesh] products have helped many women."
"The slings I do, although synthetic, have helped many women," he said. "I put the sling in differently. I don't follow the instructions that are outlined because I have a unique skill set that allows me to make the operation fit the patient. I don't make the patient fit the operation. That is the flaw. There is no one size fits all, and not every woman wears a size 7 shoe."
Two years ago, Roxann Bentz was 67 and had a cystocele (prolapsed bladder) and some urinary incontinence. The Bucks County, Pa., woman researched physicians to repair the problem. Bentz, a registered nurse, was aware of poor outcomes and found a surgeon who specialized in the procedure. "I knew he had done many of these," she said.
Bentz, an active woman who enjoys biking and canoeing, said the recovery was fine, and she has had no problems since the surgery.
Raz, who said he has removed 1,800 mesh implants in the past six years, said vaginal bacteria creates a potential for chronic mesh infection and pain in some patients, and mesh should not be used in the vagina.
"We took patients with pelvic pain and mesh complications and those without pain. We removed four segments. All of those with pelvic pain were positive for live bacteria in the mesh," Raz said. "Those without pain had no DNA positive for bacteria in mesh."
More than 100,000 lawsuits have been filed against makers of mesh, according to ConsumerSafety.org, making it "one of the largest mass torts in history."
In October 2016, a judge upheld a $14.3 million jury award for three women who were injured by a Boston Scientific mesh device, and in 2015, Boston Scientific announced a settlement of $457 million for 6,000 mesh lawsuits.
Kate Haranis, a spokeswoman for Boston Scientific, said the company stands behind its products and noted that "Nearly one million women have been successfully treated with Boston Scientific Urogynecologic mesh and our pelvic floor therapies are supported by more than 60 clinical publications."
Lawsuits have been filed by the states of Washington, California, Kentucky and Mississippi against mesh maker Johnson & Johnson and its subsidiary, Ethicon, saying that product marketing should have provided more detail about the risks. They accuse the company of deceiving physicians and patients, and say the mesh has destroyed the quality of life for some of them, according to the Associated Press.
In response, 63 surgeons in Washington wrote a letter in December to state Attorney General Robert Ferguson denying that they were misled, and expressing the concern that the lawsuit would "eliminate the mid urethral mesh sling as a treatment option for women in Washington." This, they said, would have a negative impact because the sling is standard surgical treatment for stress urinary incontinence.
Jeffrey L. Clemons and two other physicians who signed the letter disclosed they had been retained by the defense, but that they were not being paid nor receiving any assistance.
Ethicon called the lawsuit filed by Kentucky "unjustified" and said "the company plans to vigorously defend itself against the allegations."
Endo International settled 22,000 mesh lawsuits in 2017 for $775 million and said its president and chief executive, Paul Campanelli, called it "a very important milestone for Endo to have reached agreements to resolve virtually all known U.S. mesh product liability claims."
In 2008, according to the Food and Drug Administration, "the number of adverse events reported to the FDA for surgical mesh devices to repair POP [pelvic organ prolapse] and SUI [stress urinary incontinence] for the previous 3-year-period (2005-2007) was 'over 1000.' " The agency said the complications included mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems.
From 2008 to 2010, the FDA received 2,874 reports of complications associated with surgical mesh. The FDA's literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication.
According to a study published last year, all surgical meshes in the United States were cleared by the FDA's 510(k) process, "in which devices simply require proof of 'substantial equivalence' to predicate devices, without the need for clinical trials." The study also said that "recalled meshes associated with adverse effects may, indirectly, continue to serve as predicates for new devices raising concerns over the safety of the 510(k) route." The authors conclude that improvements for regulation are "urgently required."
An FDA spokeswoman said that the agency is making improvements. The agency reclassified surgical mesh in 2016 for transvaginal pelvic organ prolapse (POP) repair from Class II (which includes moderate-risk devices) to Class III (which includes high-risk devices). "FDA is reclassifying these devices based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device, and these devices present a potential unreasonable risk of illness or injury," the final order reads.
In addition, the agency is, "issuing postmarket surveillance orders to 34 manufacturers who had cleared 510(k)s for transvaginal repair of pelvic organ prolapse," the spokeswoman said. As a result of the FDA's actions, she said, "all manufacturers ceased marketing of surgical mesh intended for transvaginal repair of posterior compartment prolapse (rectocele). Only three surgical mesh products intended for transvaginal repair of anterior compartment prolapse (cystocele) remain legally marketed."
The FDA is also planning an advisory meeting on Feb. 12 to share evidence and expert opinion about the safety and effectiveness of transvaginal mesh.
Margolis said removing mesh that has scarred into place is like trying to remove bubble gum from hair or rebar from concrete.
"I have seen women with their vaginas essentially mutilated. So scarred and disformed as a result of the chronic inflammation and scarring from the mesh as to be left with a nonfunctional vagina or dysfunctional bladder and urethra," Margolis said. "When tissue, the vagina, bladder or bowel is damaged enough, no surgeon can fix the tissue past a certain point - and I see that with great regularity, even after mesh was implanted years before."
If women are concerned about complications because of a mesh, what should they do if they are plagued by stress incontinence or prolapse?
There are nonsurgical options, such as Kegel exercise and pessaries, that can help with stress incontinence, Margolis said.
Raz and Margolis prefer slings made from organic, biologic material such as tissue or tendons from their own patients.
Margolis also said that the Burch procedure, a surgical procedure in which the neck of the bladder is suspended from nearby ligaments with suture is excellent, but noted that it, too, can fail.
Vaginal mesh is no longer being used in Australia, Ireland and Scotland. In July, the United Kingdom instituted a temporary ban while long-term damage is assessed.
https://doctor.ndtv.com/womens-health/vaginal-mesh-causes-health-problems-in-many-women-1981984
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested