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Ethicon Media Monitoring 2/1/2018
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New Zealand’s Medsafe regulatory body removes pelvic mesh products from market
Jan 31, 2018 | Mass Device
By Fink Densford
New Zealand’s regulatory body Medsafe has taken steps to remove a number of surgical mesh products from the country, according to a release posted today. -
Supply of some surgical mesh products stopped, but those in stock will still be used
Jan 31, 2018 | Stuff
By Cate Broughton
Surgeons will continue to use controversial surgical mesh devices to treat stress urinary incontinence (SUI) in hundreds of New Zealand women each year despite a lack of information about their safety sought by Medsafe. -
Campaigners celebrate after breakthrough in bid to ban full mesh implants
Feb 1, 2018 | Hull Daily Mail
By Patrick Daly
Hull campaigners are celebrating a major breakthrough in the drive to have mesh implant surgery banned in the UK. -
Product Liability Group Of The Year: King & Spalding
Jan 31, 2018 | Law 36o
By Dan Packel
... Partner Lana Varney also came aboard with a team from Norton Rose Fulbright in April. She noted that the number of claims in her current areas of focus, the pelvic mesh mass tort, was exploding thanks to social media.
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New Zealand’s Medsafe regulatory body removes pelvic mesh products from market
Jan 31, 2018 | Mass Device
By Fink Densford
New Zealand’s regulatory body Medsafe has taken steps to remove a number of surgical mesh products from the country, according to a release posted today.
The agency said the product’s removal was the outcome of a recent regulatory action on surgical mesh products, specifically those designed for treating pelvic organ prolapse via transvaginal implantation and one mini-sling product designed to treat stress urinary incontinence.
Medsafe said that last December it requested safety information from four surgical mesh suppliers in New Zealand, following action taken by Australia’s TGA as it looked to review meshes used for urogynaecological use.
The earlier TGA’s investigation ended in regulatory actions to remove the devices from the market, MedSafe said, and similarly resulted in their removal from New Zealand’s market.
“All four companies contacted have responded and have confirmed that all products removed from the Australian register are no longer supplied in New Zealand,” Medsafe group manager Chris James said in a press release.
The regulatory action only relates to the use of surgical mesh in pelvic organ prolapse via transvaginal implantation and a single product designed for stress urinary incontinence, and does not affect supply of surgical meshes for other uses, including hernia repair or stress urinary incontinence, according to the release.
Medsafe said it will continue to work with the companies to make sure appropriate changes, including warnings in instructions for use, are made in New Zealand as soon as possible.
“The section 38 review and restrictions are the strongest action possible under current legislation. As with all medical devices, Medsafe continues to monitor the use of surgical mesh products. Information for surgeons and patients is published on the Medsafe website. Patients who are considered for surgery, where there is potential for the implantation of surgical mesh products, should be fully informed about the benefits and risks of treatment and informed consent obtained,” James said in a prepared statement.
https://www.massdevice.com/new-zealands-medsafe-regulatory-body-removes-pelvic-mesh-products-market/
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Supply of some surgical mesh products stopped, but those in stock will still be used
Jan 31, 2018 | Stuff
By Cate Broughton
Surgeons will continue to use controversial surgical mesh devices to treat stress urinary incontinence (SUI) in hundreds of New Zealand women each year despite a lack of information about their safety sought by Medsafe.
Action taken by Medsafe to limit the supply of surgical mesh devices in December has left some of the targeted devices in supply.
Four companies were required to provide safety information for 29 surgical mesh products within 45 days under section 38 of the Medicines Act 1981 following Australia's Therapeutic Goods Administration (TGA) review and ban of the devices.
On Wednesday Medsafe said 17 products from three companies – Boston Scientific NZ Ltd, Culpan Medical and Endotherapeutics NZ Ltd – were no longer being supplied in New Zealand as a result of the action.
Supply of six Johnson & Johnson products had been temporarily suspended in New Zealand "pending the outcome of the company's ongoing discussions with the TGA", Medsafe said.
However, products already on hospital shelves would not be affected, despite the company not complying with Medsafe's request for safety information.
Christchurch gynaecologist and Urogynaecological Society of Australasia (UGSA) board vice chair John Short said Medafe's action was very positive and he saw it as an endorsement of surgical mesh slings used to treat SUI.
"I would struggle to find another gynaecological device or procedure that has been subjected to that level of scrutiny and research and endorsed. So that gives me and should give our patients and the public absolute confidence in these procedures."
Short said he used the Johnson & Johnson Gynecare TVT mesh sling device in about 50 SUI surgeries each year and considered it safe and effective.
He said he would continue to use existing stock of the product and had spoken to two companies about a replacement product if Johnson & Johnson didn't recommence supply.
Changing to an alternative product would require training as each one could be slightly different to use in the procedure, Short said.
Minister of Women Julie-Anne Genter said DHBs would have to "decide on a course of action with respect to stock already held".
"Medsafe are having that conversation with DHBs. One option may be to negotiate returning it to the supplier."
Charlotte Korte, from patient advocacy group Mesh Down Under, said Medsafe had created confusion and distrust by not providing clear evidence of safety for products that remain in use.
A working group – including a urologist, Mesh Down Under, gynaecologists and surgeons – have been developing advice for patients about mesh procedures used to treat stress urinary incontinence in women.
It would not be possible to provide the best advice without more information about the updated safety information suppliers had , Carmel Berry from Mesh Down Under said.
"It's important Medsafe clarify what products have met requirements of Section 38 of the Medicines Act and the director-general of health has been satisfied they are safe."
A supplier of Johnson & Johnson mesh products in New Zealand was approached for comment.
PRODUCTS NO LONGER SUPPLIED IN NZ:
Boston Scientific NZ LtdSolyx
Uphold Life
Culpan MedicalColoplast – 9 models
Endotherapeutics NZ LtdTOA Sling
TVA Sling
Multi Purpose Sling
BSC Mesh
EndoGYNious
Ophira Minisling
https://www.stuff.co.nz/national/health/101032457/Supply-of-some-surgical-mesh-products-stopped-but-those-in-stock-will-still-be-used
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Campaigners celebrate after breakthrough in bid to ban full mesh implants
Feb 1, 2018 | Hull Daily Mail
By Patrick Daly
Hull campaigners are celebrating a major breakthrough in the drive to have mesh implant surgery banned in the UK.
Emma Hardy, MP for Hull West and Hessle, has revealed health ministers have promised a full review into all the mesh implant operations carried out, dating back to 2005.
The retrospective 13-year audit means cases such as Angie Sykes’ will be reviewed as part of a national NHS survey . The former karate enthusiast, who lives in west Hull, has been left in “constant pain” after having a vaginal mesh implant inserted in 2011 in an attempt to solve her stress incontinence.
Ms Sykes says she hopes the news of the audit will uncover the evidence needed to “make people sit up and take notice” of the ordeal mesh sufferers’ have been put through.
The Department for Health and Social Care refused to comment when approached about the news of the upcoming audit.
But Ms Hardy said her and MPs from the all-party group on surgical mesh met with health minister, Lord James O'Shaughnessy, who confirmed he had tasked officials with carrying out the audit, which is expected to be completed by April.
Lord O'Shaughnessy reportedly also told the MPs he would be writing to the Department for Work and Pensions to determine whether personal independence payments – currently paid out to those with physical and mental disabilities to assist with their cost of living – could be widened to cover mesh victims.
Ms Hardy is campaigning to have surgical mesh implants banned, saying that as many as 10 per cent of the 100,000 women who have undergone the procedure suffered complications. New Zealand recently put a stop to it and Australia also cracked down on its use.
The Labour MP said she was “delighted” the Government had conceded and would now be collecting evidence on the impact of mesh.
“This is a really positive step forward,” she said. “The Government has often said there isn’t the evidence to put a stop to the operations, so this will be so important.
“It will give them the evidence. They are going to look at every woman that has had it and look at how many of those have gone on to need support from pain clinics or require further surgery.”
The NHS has already effectively outlawed the use of mesh surgery for pelvic organ prolapse, allowing it only for “research purposes”. But it is still administered to those with stress incontinence. Ms Hardy wants future care guidelines to rule out the practice entirely.
Ms Sykes, 45, called the move “a step in the right direction”.
“This will absolutely help and hopefully now people will sit-up and take notice,” said the former Heron Foods employee.
But the mother-of-three said the Government should go further and put all mesh operations on hold until after the review has concluded.
“I feel they should put a pause on any future operations during this review so that nobody else can be added to the numbers affected. I’m hoping it is banned altogether,” she said.
Ms Hardy said the minister had explained the procedure won’t be paused during the audit but had assured that those being given mesh will be closely monitored to watch-out for possible side-effects.
She also said NHS England had written to surgeons to emphasise the need to make patients “fully aware of the consequences and associated risks” with a mesh implant.
GPs were also written to by the national health body, advising them on symptoms to watch for in mesh sufferers.
Sharon Hodgson MP, the Labour shadow public health minister, said she wanted “the halting of the use of this product until we know more about it”.
http://www.hulldailymail.co.uk/news/hull-east-yorkshire-news/campaigners-celebrate-after-breakthrough-bid-1141824
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Product Liability Group Of The Year: King & Spalding
Jan 31, 2018 | Law 36o
By Dan Packel
Law360, Philadelphia (January 31, 2018, 12:15 PM EST) -- King & Spalding LLP notched courtroom wins for R.J. Reynolds Tobacco Co. in so-called Engle progeny cases and Johnson & Johnson in the first trial over the alleged connection between the company's talc products and mesothelioma to go to verdict, helping land the firm among Law360's Product Liability Groups of the Year for the fifth straight time.
The group grew to 48 partners and 225 additional attorneys working out of eight offices in 2017, after adding new teams in New York City and Austin, Texas. Practice group leader Carol Wood chalked up the group's success, as well as its attractiveness to laterals, to its ability to do the groundwork on cases and ultimately take them to juries.
"We try all the cases," she said. "Oftentimes, firms are very good in working up the cases, but we do that and also field a number of trial teams simultaneously. It's something we've always prided ourselves on, and it is a hallmark."
The group's trial lawyers were especially busy in Florida over the past year, with three wins on behalf of R.J. Reynolds in Engle progeny tobacco cases, in which former members of a decertified class action can bring individual lawsuits.
Partner Randy Bassett, who serves as lead trial counsel for R.J. Reynolds, noted that juries in these cases get exposed to previous rulings detailing the tobacco manufacturers' negligence, concealment of information, and their involvement in a conspiracy to hide the health impact of their products.
"As a defendant, you're behind the eight ball," he said. "You've got to recognize those findings and explain to the jury the context of those findings."
That involves turning their focus to the individual and his or her life story as it relates to smoking, Bassett explained.
The firm won two complete defense verdicts in two trials, one in June and the other in December 2016, where defendants were seeking a total of $21 million in damages. In another trial, from April, while a jury found R.J. Reynolds liable, it also pinned 95 percent of the fault on the individual and awarded no damages.
In the tobacco litigation, King & Spalding also saw appeals court judges reverse three cases with jury verdicts totaling nearly $40 million, while successfully defending two other defense verdicts.
"We recognized early on that you're not going to triumph in all of these cases, so we made the decision early on to coordinate closely with the appellate team," Bassett said.
In California, King & Spalding partner Alex Calfo was involved in a landmark win on behalf of J&J, when a jury ruled in November there was no evidence the company's Baby Powder was unsafe.
By only naming cosmetics and powder manufacturers, Calfo said, plaintiffs seeking to pin the blame on talc for their mesothelioma make it difficult for defense attorneys to point to alternative exposures.
"What we had to do is rely on the science of the talc in the powder itself," he said.
The group was also ready to go to trial in an earlier talc and mesothelioma case in October 2016, but the plaintiff dismissed J&J during jury selection.
"We had a number of trials this year, and that really just seems to be growing, and it's not just in one location and in one industry," Wood said.
Newcomer John Hooper, who led a team of litigators from Reed Smith LLP to King & Spalding in July, pointed to that trial strength in explaining his decision to make the move.
In November, Hooper helped secure final approval of a class action settlement for client Toyota in the Takata air bag litigation. At the heart of the $278.5 million settlement is an extensive outreach program aimed at ensuring the widespread replacement of the faulty part in the air bags.
"Toyota was the first [original equipment manufacturer] that decided to resolve the Takata litigation using the outreach program as the primary consideration for the settlement," Hooper said. "Toyota made this decision even before any of the other OEMs decided they would agree to a similar settlement."
Partner Lana Varney also came aboard with a team from Norton Rose Fulbright in April. She noted that the number of claims in her current areas of focus, the pelvic mesh mass tort, was exploding thanks to social media.
"We're going to see bigger, more complex, more tangled mass torts and viral litigation," she said. "You're going to need trial bench strength to handle the volume."https://www.law360.com/articles/999180/product-liability-group-of-the-year-king-spalding-
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