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Ethicon Media Monitoring 8/7/2018
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Backlash against Mesh Implant
Aug 3, 2018 | Ethical Consumer
In 2006, Johnson & Johnson launched a mesh used to treat incontinence onto the medical market. -
Thousands Purged from Ethicon Pelvic Mesh MDL Today
Aug 6, 2018 | Mesh Medical Device News Desk
By Jane Akre
Today, Monday, August 6, Judge Goodwin has been busy dismissing pelvic mesh cases from the Ethicon multidistrict litigation (MDL). -
The men left in agony after being given surgical mesh implants to repair a hernia
Aug 6, 2018 | Daily Mail
By Lois Rogers
Mario Spacagna is eternally grateful for the surgery that removed his kidney tumour.
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Aug 3, 2018 | Ethical Consumer
In 2006, Johnson & Johnson launched a mesh used to treat incontinence onto the medical market. The implant was approved in the US and EU without a clinical trial, and was used for the next six years in operations on thousands of women – even after the company discovered in 2007 that it had a higher failure rate than two earlier devices.
Since then, hundreds of women have reported debilitating pain and the company is now facing class actions in Australia, the UK and the USA.
In 2017, the first patient was awarded $57 million, after evidence emerged that the company ignored warnings from doctors – both those working for the company and conducting independent trials.
No clinical trial
Ethicon, a subsidiary of Johnson & Johnson, began producing the implant known as TVT Secur in 2006. The company had produced two earlier mesh implants, which meant that the new device could be approved for use in the EU and the USA without full clinical testing.
The company began to market the implant after tests on sheep and five weeks’ monitoring in 31 women.
Although this process was legal, Carl Heneghan says that the approval has “led to direct patient harms”. But Ethicon saw its advantage as “priceless” in bringing the product to market ahead of competitors, according to company documents that emerged during a recent lawsuit against it.
Heneghan, who is professor of evidence-based medicine at the University of Oxford, says this behaviour was “unacceptable”. "It just blatantly says we don't care about patients. We don't care about safety, we just want to get out and start making money”.
Around 10,000 women receive transvaginal mesh implants each year in the UK as treatment for prolapse or urinary inconsonance, often following childbirth. For most, there are no serious complications. But since 2006 – when Johnson & Johnson launched the new mesh – the number experiencing chronic pain has significantly grown.
Ignoring evidence
Ahead of the device’s original launch, Prof Bernard Jacquetin a French gynaecologist was invited to give advice on the implant. But on arrival he was presented with a finished product, boxed-up and ready for launch, he stated during the trial.
When Jacquetin and colleagues later carried out a study of 40 patients, they found that the new device had success rates of just 77% two months after surgery, far lower than the 85-90% success rates reported for Ethicon’s earlier devices. When Ethicon’s marketing manager, Fabrice Degeneve learned of the figures, he responded: “How should we handle this without compromising the use of this new technique?” emails from the recent lawsuit show.
Director of sales, Xavier Buchon, replied suggesting that the company withhold the results while reviewing the patients included in the analysis.
Emails from other Johnson & Johnson staff said that there was a dangerous blurring of the “lines between commercial and research” divisions and that colleagues were “constantly spinning data”.
Insufficient warnings
Since 2008, Ethicon’s own doctors also began expressing concern. The company’s associate medical director wrote to managers pointing out that the information Ethicon provided to surgeons was from 2005. In particular, she expressed concern that the “potential adverse reactions” had not been changed in the light of “post-market knowledge”.
In 2009, she again wrote to managers, stating that several of the complications listed should no longer be referred to as “transitory”. "From what I see each day, these patient experiences are not 'transitory' at all.” However, Ethicon admits that it did not update the advice at the time.
Side-affects of the device can include vaginal scarring, painful sex, and pain in pelvic back and legs. A small minority of patients experience these side-effects. But for some they have been severe enough to leave the patient wheel-chair bound.
Ethicon last updated the advice in 2015 to state that some of these affects could be permanent. But even then the company is accused of using incomplete and insufficient risk assessment data to do so.
Over 100,000 women are now suing manufacturers of the mesh in the US alone. Johnson & Johnson faces the greatest number of cases.
And what about the NHS?
The NHS is also facing lawsuits from 800 women in the UK.
One in fifteen women have to had the device fully or partially removed, according to NHS data and the use of mesh has been suspended altogether as of July 2018 until it will be fully reviewed next year.
The incident has lead many to question the system for approving treatments before NHS use. Carl Heneghan stated that the decision to allow the treatment without clinical trial “made it impossible to provide informed choice to women, and points to a regulatory system that is failing patients.”
Sling the Mesh
The Sling the Mesh campaign states that the use of vaginal mesh is the ‘Bigger disaster since thalidomide.” They have been campaigning to raise awareness of the issue and for the mesh’s use to be suspending pending review.
http://www.ethicalconsumer.org/latestnews/entryid/2279/backlash-against-mesh-implant.aspx
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Thousands Purged from Ethicon Pelvic Mesh MDL Today
Aug 6, 2018 | Mesh Medical Device News Desk
By Jane Akre
Today, Monday, August 6, Judge Goodwin has been busy dismissing pelvic mesh cases from the Ethicon multidistrict litigation (MDL).
These are women who have “mesh in place” from the Gynecare family of meshes which includes: TVT, Retropubic (TVT) or Abdominal (TVT-A) System, Gynecare TVT Obturator System (TVT-Obturator), Gynecare TVT Abbrevo Continence System (TVT-Abbrevo), and/or Gynecare TVT Exact Continence System (TVT-Exact),
They are filed in the Ethicon (Johnson & Johnson) MDL or multidistrict litigation where cases are consolidated awaiting trial. Dismissed without prejudice, means they can be refiled if the woman undergoes any future mesh revisions/ removals within five years.
FIVE ORDERS TODAY
Nearly 1,500 cases were dismissed without prejudice by Judge Goodwin before lunch today, See #6509, #6508, #6507. Two additional #6510 and #6511were filed after lunch. Each filing has approximately 500 names of plaintiffs. Altogether they removed 2,471 from the active list of defective product cases naming Ethicon.
In #6508, two plaintiffs are deceased (Milam 2:15-cv-05586, and Bunch 2:15-cv-04772), and three have lines through them (Lefever 2:14-cv-26332, Steward 2:14-cv-23424, and Koch 2:15-cv-07315).
#6507, includes one plaintiff who has died, (White 2:13-cv-28950). If a plaintiff dies, her estate must motion within 90 days for a substitute to continue the case. See judicial order here.
Will they ever have their day in court?
At one time in excess of 104,000 cases populated this multidistrict litigation (MDL) where cases are consolidated awaiting trial. , Johnson & Johnson’s Ethicon division was facing the most cases, 40,000 earlier this year but last month, Judge Goodwin said that number had been whittled down to 10,000 cases.
Some of those remaining are set for trial this month.
Ethicon argued the Gynecare family of meshes it produces are still on the market, still making money for Ethicon and even called the Gold Standard by at least one medical society, AUGS. Nevermind that some of the Ethicon meshes have been found to be defectively designed in a court of law (Huskey, TVT-O).
QUALIFYING PROCEDURE
Pretrial order #293 (Amended to 298), defines the future for these plaintiffs.
Some of these plaintiffs range from having a mesh in place with no problems to being unable to undergo additional surgeries for a host of reasons.
Judge Goodwin has made it clear that within five years if a patient has a “qualifying procedure” she can refile as that could substitute for a full mesh removal surgery. That means:
“For purposes of this order only, Ethicon agrees that plaintiffs who, although their treatment does not qualify as Revision Surgery within five years after the election, have more than one (1) in office revision of the mesh and who also have concomitant treatments of trigger point injections, vaginal physical therapy or utilization of vaginal Valium, that are demonstrated to be necessary by 6 contemporaneous medical records and that are performed by a competent, licensed physician who is neither retained nor funded by a plaintiff’s lawyer or a litigation funding entity for purposes of performing such procedures or treatments, nor where the litigation funding company has a relationship with the physician or the facility (or any related entity), will be treated the same as those plaintiffs who have a Revision Surgery within the five year period, as described above; however, the applicable statute of limitations shall begin to run upon the completion of the second of such multiple qualifying procedures.”
ADDITIONAL DOCKET ACTIVITY
#6512 is an Inactive Docket Order stating that the following 27 cases have agreed to a settlement model with regard to Ethicon.
The court finds it unnecessary to conduct further proceedings on the active docket for those cases. Both sides may submit an agreed order of dismissal with prejudice on or before August 31 2018 to have the case finalized. Otherwise the court will hold a hearing to determine the appropriate actin pertaining to any remaining cases on the inactive docket. Counsel for both plaintiff and defendants are directed to provide quarterly reports as to their progress in dismissing cases on the inactive docket. The case can be reinstated if one of the parties motions the court showing, “good cause for such reinstatement.”
Among them Long v Ethicon, 2:13-cv-02133 (Lanier Law, NYC), Menegos v Ethicon 2:13-cv-10117 (Fentersheib Law), Glasco 2:13-cv-12041 (Lanier Law), Sheehe 2:13-cv-31020 (Motley Rice).
Also today Blizzard & Nabors LLP, counsel for some plaintiffs agreed to a confidential Settlement Agreement with Ethicon and some of its clients. Ethicon will pay the settlement to the Blizzard-Ethicon Qualified Settlement Fund to be dispersed according to the terms of the Settlement Agreement and to attorneys for fees and costs and any lienholders including governmental entities and to the Special Master and Fund Administrator.
The Settlement Alliance, LLC of Houston, TX is the appointed fund administrator.
https://www.meshmedicaldevicenewsdesk.com/thousands-purged-from-ethicon-pelvic-mesh-mdl-today/
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The men left in agony after being given surgical mesh implants to repair a hernia
Aug 6, 2018 | Daily Mail
By Lois Rogers
Mario Spacagna is eternally grateful for the surgery that removed his kidney tumour.
But he fears he will pay the physical costs of his survival for the rest of his life as a result of a secondary operation following the successful cancer surgery.
‘I am in constant pain, day and night,’ explains the 75-year-old from Southampton. ‘I can be walking down the street and my legs will suddenly fold up under me. I can’t breathe and I can’t speak.
‘Sometimes it is a general ache and other times it is a sharp stabbing sensation like having a knife stuck in my side. Anyone who saw me would think I was having a heart attack.’
Mario has had a large, ten-inch square sheet of plastic surgical mesh placed internally to repair damage caused by the partial removal, in October 2013, of one of his kidneys which was affected by a large cancerous tumour.
‘I was left with a bulge in my side where the kidney surgery had left a gap in the muscles holding everything together,’ he says. ‘It was about half the size of a football after the operation. A small mesh was put in to hold everything in place. It didn’t work so in October 2015 they went back. They couldn’t take out the original mesh so they put another huge piece of mesh over the top. It didn’t work either.’
Quite apart from the ongoing pain, he says he still has ‘this huge bulge — clothes don’t fit me properly and I’m very self-conscious about it’.
‘The doctors say they can’t take the mesh out because the flesh will have grown into it. It has very sharp edges which dig in all the time and sometimes touch nerves. The pain is gradually getting worse and there is apparently nothing they can do about it.’
There are dozens of different types of plastic mesh in use for surgical repairs, most made from a type of material called polypropylene — which is also used for ropes.
It causes an inflammatory reaction but in most people, this settles down. However, some have experienced other problems, as the mesh moves or migrates, or its sharp edges cause continuing pain.
If it is near the vagina or bowel, where there are naturally high levels of bacteria, experts say it can set up an infection which may degrade the material causing it to break up into fragments, burrowing into tissue.
This is what has happened to countless women, who have undergone surgery using a form of surgical mesh (also known as tension-free vaginal tape or TVT) to treat incontinence, typically as a result of damage post childbirth. For over ten years they have been reporting injuries caused by the material, with some left unable to walk and reliant on wheelchairs because of nerve damage. Last December Chrissy Brajcic, a 42- year-old Canadian woman died after developing multi-drug-resistant infections following pelvic mesh surgery, and then sepsis.
Following a long running Good Health campaign, the use of mesh to treat incontinence has now been suspended pending a government review led by Baroness Julia Cumberlege into its safety.
And under new clinical guidelines, any surgeon wanting to use it will be expected to show ‘documented evidence’ they have additional training and experience to ensure they have specialist skills in the use of the material.
The guidelines also require hospital trust medical directors to ensure procedures are in place to, ‘support patients who have had previous mesh surgery who may have concerns’.
The guidelines cover the use of mesh for urinary incontinence in both men and women but the review and guidelines will not help others such as Mario or others like him given the mesh for hernia or bowel repairs where it has gone wrong.
Kath Sansom who runs the patients’ pressure group Sling the Mesh which is campaigning for a complete ban on mesh says her 6,400 members now include more than 300 men.
They have either suffered damage from use of mesh for hernia repairs — where part of the digestive tract protrudes through a weak point of the stomach muscle wall — or have been left with injuries following the use of mesh for bowel repair.
Kath Sansom says her investigations have revealed seven mesh-associated deaths have been reported to the Medicines and Healthcare products Regulatory Agency (MHRA) — the MHRA says its investigations showed none of the deaths was related to use of the material.
Mesh is routinely used in thousands of hernia repairs on men every year and while many have benefited, some report it’s caused them serious and ongoing problems — and in Good Health’s investigations into the use of mesh, patients have told us they were never warned there was a risk the material might move around or even break up into fragments.
‘We appreciate there may be no other solution for hernia than to use a mesh, but not all mesh material is the same and none of the people who have contacted us say they were warned of the risks,’ Kath Sansom told Good Health.
‘We also think that some types of mesh material are totally inappropriate for use in the human body.
‘A lot of the time mesh has been used because it is cheaper and requires less skill than doing a repair using a patient’s own tissue. It is a bit like using stick on patches to repair clothes. There will now be a problem with surgeons no longer having the necessary skills to do complex stitched repairs.’
Austin Obichere, a specialist colorectal surgeon at University College Hospital, London, who operates on men damaged by mesh used for hernia or bowel repairs says their problems are unlikely to be as severe as those experienced by women because the stomach wall has fewer bacteria than the genital tract, bladder or bowel, and is a better environment for the mesh to work.
But he adds: ‘Four to six per cent of [male] hernia patients may suffer serious pain which can mostly be sorted out. They should always be warned of the risk of problems before the operation.’
Hernia patient Keith Devine insists he was never told there was a chance of the mesh triggering a reaction. Keith, 56, from Weston-super-Mare in Somerset, had to give up his job as a senior Whitehall civil servant after having a hernia operation in November 2016.
He’d paid £1,400 to have it done privately at a London hospital to avoid joining an NHS queue.
‘My GP had told me I needed a hernia repair, it was a completely routine procedure but I would have to wait 15 months to get it on the NHS,’ recalls Keith, who is separated from his partner and has two young step-daughters.
‘I had always been fit and healthy and a keen tennis and squash player. I was actually teaching squash at a local club the day before the operation. I was keen to get it out of the way and get back to work.
‘That hasn’t happened. I had diarrhoea, sickness and pain immediately after the surgery and the pain was so bad I couldn’t walk at all for about three months.
‘I still struggle to walk upstairs, I can’t work or travel far. I wake up every night as the painkillers wear off and it’s also made me impotent. It’s basically ruined my life.
‘I had no idea there was such an epidemic of problems with this stuff and I wasn’t told of the risk.’
Keith has taken legal advice and complained to the General Medical Council about the intractable pain caused by what he believes was substandard treatment.
Ian Waterfield, 56, a former chef from Huddersfield, is also taking legal action, following bowel repair with mesh.
He is one of around 100 patients who say they suffered after surgery performed by surgeon Anthony Dixon who worked at Southmead Hospital in Bristol as well as privately. (Mr Dixon has now had restrictions placed on him by the General Medical Council, preventing him from carrying out bowel repair surgery pending an inquiry.)
Ian was referred to Mr Dixon through the NHS and underwent the mesh repair operation in 2010 but has since had to undergo repeated operations and the removal of a section of his bowel. ‘I am in constant pain — it’s like bits of broken glass sticking into me,’ he says.
Like the hernia patients, those who’ve experienced problems with mesh for bowel problems are not part of Baroness Cumberlege’s independent medicines and medical devices safety review.
Surgeons point out there is no alternative to mesh for many patients, whether it’s for hernia, bowel problems or incontinence.
Arjun Shankar, a specialist in complex hernia repairs at University College Hospital, London, said surgery to the abdominal organs causes a hernia in one in four cases. ‘Mesh is the only treatment,’ he said. ‘Clearly there was a problem using one type of this material in women because it sticks to the tissue.
‘We use a mesh that is coated with a non-stick chemical, but even so there are problems with pain in a small percentage of patients. Some of them can be treated by ablation [cauterization] of affected nerves.’
Marcus Drake, a professor of urology at Bristol University, also defended the procedure. ‘I have myself had a hernia repair about 15 years ago using this mesh and I have never had any problems,’ he says.
‘There are two possibilities to explain why things might go wrong. Firstly poor surgical technique or a failure to appreciate the implication of inserting the material into poor quality tissues which means a greater risk of infection.’
He adds that obesity — an increasingly common problem — slows healing and increases infection risk.
And in women, menopausal thinning of vaginal tissues causes similar complications.
‘Used correctly mesh is infinitely superior to the old operation of colposuspension [a stitched procedure using the patient’s own tissues to hold the bladder up] which involves a deep six or seven inch cut through the muscles you use to sit up. It leaves patients absolutely physically hammered and there is a very long recovery. Being unable to exercise for three months, in a middle-aged woman is not good.’
Professor Drake is part of a study team comparing results in 180 men who have undergone mesh repair for urinary incontinence with another 180 who have had an artificial valve inserted to control the leaking. He agrees the material should not be used pending the results of this study which are not due until 2020.
Meanwhile Mario, a divorced former dockworker, who has three sons and three grandchildren but lives alone, says he’s been given no advice or support on dealing with his crippling pain.
Instead, in a story tellingly similar to the ones told by women for years when they tried to report their problems with TVT, he says: ‘I have mentioned the pain every time I have been for my six monthly cancer check ups but they said there is nothing they can do. I was told in March this year I don’t need any more cancer checks, and that the pain from the mesh is a small price to pay to have my life saved. I’m conscious that at my age they are not going to push more treatment at me, but I wasn’t told about the side-effects of this mesh. Something like that is bound to have sharp edges, but it was just never mentioned.’
Southampton General Hospital where Mario’s treatment was carried out said the hospital would be happy to discuss his issues via their patient support service.
In a statement to Sling the Mesh about the deaths, the MHRA said patient safety is its highest priority but added: ‘We recognise some women do develop serious complications. We also know many women gain benefit from these surgical procedures for what can be extremely debilitating conditions. The decision to use mesh should be made between a patient and clinician, recognising the benefits and risks in the context of the distressing conditions being treated.
‘We continue to work closely with NHS England, NICE and professional bodies, and we are all committed to helping address the serious concerns raised by women who have experienced complications.’
Mr Dixon has declined to comment about the complaints citing patient confidentiality. North Bristol NHS Trust, which operates Southmead Hospital, has said: ‘We would like to reassure patients that we are taking this very seriously and our investigations are continuing. It would be inappropriate for us to comment on specific details while our investigations are ongoing.’
http://www.dailymail.co.uk/health/article-6032443/The-men-left-agony-given-implants-repair-hernia.html
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