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Ethicon Physiomesh Withdrawn from Market, Never Formally Recalled
Jul 17, 2017 | Lawyers and Settlements
By Gordon Gibb
Atlanta, GAA myriad of issues with regard to Ethicon Physiomesh and the accompanying Ethicon Physiomesh complaints were partially responsible for Ethicon, a subsidiary of Johnson & Johnson, triggering a market recall of their product last year. -
Women meet MPs over vaginal mesh implants
Jul 18, 2017 | Medical Plastics News
By Reece Armstrong
Around 60 women who have experienced chronic pain and other issues due to the devices will meet with MPs. -
Senior doctors call for public inquiry into use of vaginal mesh surgery in UK
Jul 18, 2017 | The Guardian
By Hannah Devlin
Senior doctors have called for a public inquiry into the use of vaginal mesh surgery amid mounting concerns that a significant proportion of patients have been left with traumatic complications. -
Invokana Amputation Injuries on the rise
Jul 19, 2017 | The Legal Examiner
By Shezad Malik MD JD
Invokana Amputation Injuries. According to the latest court lawsuit data, Invokana related serious injuries are on the rise, especially Invokana Amputation Injuries.
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Ethicon Physiomesh Withdrawn from Market, Never Formally Recalled
Jul 17, 2017 | Lawyers and Settlements
By Gordon Gibb
Atlanta, GA - A myriad of issues with regard to Ethicon Physiomesh and the accompanying Ethicon Physiomesh complaints were partially responsible for Ethicon, a subsidiary of Johnson & Johnson, triggering a market recall of their product last year.
There are those who assumed the Physiomesh was actually recalled in the US due to its withdrawal from the US market.
However, there was never a formal recall. While there was a formal recall in at least one instance outside of the United States, that wasn’t the case in the US. While it has not been established if any issues with regard to Ethicon Physiomesh side effects might have qualified for formal recall under criteria maintained by the US Food and Drug Administration (FDA), Ethicon was nonetheless in a position to undertake a product withdrawal from the market – stopping the issuance of new product and extending refunds to hospitals and healthcare facilities willing to return unopened and unadulterated product to the manufacturer.
In spite of the lack of a formal recall in the US, Ethicon Physiomesh lawsuits have nonetheless rolled in based on a myriad of Ethicon Physiomesh complaints and adverse event reports with regard to failure of the mesh deemed at higher rates than competing products.
In an effort to illustrate some of the complaints plaintiffs are alleging, a lawyer with the Hollis Law Firm in Kansas City took to You Tube recently for a demonstration utilizing various packages of Ethicon Physiomesh.
The round mesh was found to be less-robust than the presenter expected it to be, as he was able to tear the mesh with his hands and fragment the mesh easily. Some adverse events reports noted that holes and tears had developed in the product, allowing for hernias to return.
Other adverse incident reports suggested that Physiomesh failed to remain at the deployment site, and migrated away from the hernia the mesh was meant to manage. The presenter explained the polypropylene mesh is coated with a product called Poliglecaprone on both sides – the reason for which is to help prevent the mesh from adhering to the bowel and other underlying organs, which can be problematic.
However, in spite of this coating the Physiomesh, in some patients, had nonetheless become bound with the bowel and / or intestine and the mesh had to be removed. In other cases, according to adverse event reports logged with the FDA, the double-sided coating of Poliglecaprone prevented the ultra-thin, lightweight mesh from adhering properly to the abdominal wall, which was the desired result for the mesh to properly control the hernia.
The result was migration away from the original deployment location to other areas of the abdomen where the mesh would have no useful purpose and, in some patients pose a risk for other adverse events.
There have also been allegations of issues pursuant with the packaging of Ethicon Physiomesh.
Surgical mesh is not new, having come into wider use in hernia repair and other applications for which laparoscopic surgery has been found to be less invasive, with reduced blood loss, reduced stress to the health care system, and to promote faster healing. Folded or rolled mesh would be inserted through a small incision then deployed via camera and remote instruments. While the technique is less invasive than traditional surgical procedures and has certain advantages, it has also proven problematic with the FDA actually recommending against use of mesh in some procedures.
The actual mesh material itself however, has evolved. And since mesh is not a new product per se, forthcoming incarnations of mesh have been introduced to the market through the FDA’s 510(k) Substantial Equivalence Clearance protocol, which allows for a manufacturer to skip the normal intensive testing usually required of new products in an effort to get the updated product to doctors and their patients sooner. Provided the incoming product is “substantially equivalent” to an existing product, the 510(k) Clearance is granted.In the absence of thorough testing there might be an aspect of the updated product that could prove problematic in a fashion by which the original product was not affected.
Plaintiffs assert that Ethicon Physiomesh was not adequately tested, amongst other allegations.
Ethicon Physiomesh Flexible Composite Mesh was approved in April, 2010 by the FDA under 510(k) Clearance #K093932 and deemed as ‘Substantially Equivalent’ (SESE). There was no review by a third party…
Ethicon Physiomesh side effects lawsuits have been consolidated in multi-district litigation (In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, Case No. 1:17-md-02782 in US District Court, Northern District of Georgia.https://www.lawyersandsettlements.com/articles/ethicon-physiomesh-complaints/ethicon-physiomesh-complaints-22433.html
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Women meet MPs over vaginal mesh implants
Jul 18, 2017 | Medical Plastics News
By Reece Armstrong
Around 60 women who have experienced chronic pain and other issues due to the devices will meet with MPs.
Vaginal mesh implants are made from polypropylene and are used to treat pelvic organ prolapse and incontinence following childbirth. The devices have been highly controversial and a number of women have spoken out about the pain they’ve experienced after having the mesh implants.
In Australia, 700 women have taken Johnson & Johnson to court over its vaginal mesh implants, claiming the product has ruined their lives.
In 2016 Johnson & Johnson agreed to pay over $120 million in relation to 2,000-3,000 US legal cases brought by women who claimed to have suffered organ damage due to vaginal mesh.
As well as meeting MPS, the women will attend an event, hosted by Labour’s shadow Northern Ireland secretary Owen MP who has campaigned against the implants in the past.
Smith has previously failed to get the issue debated in the house of commons but will continue try to bring it up later this year.
Speaking ahead of the event, Smith said: “I am deeply concerned that so many women have experienced profound, life-changing complications after mesh surgery. Women who have undergone the surgery invariably say they were advised that this was a simple operation, with little accompanying risk. But for too many, mesh implants have been the cause of chronic and debilitating pain. This issue must be more widely known and discussed."
A report on the use of mesh implants was published by the Scottish Parliament in March 2017. The report recommended that vaginal mesh implants could continue under certain conditions but that patients should be made aware of any alternative treatments.
BBC Good Morning Ulster spoke to Jackie Harvey, who is part of the campaign and had an implant installed 12 years ago before getting it removed.
Harvey said: “I was fine for a short time after I got the implant but I went on to develop chronic pain in the pelvic area, hips, groin and thighs. I got x-rays and saw a rheumatologist but at no stage did anyone make a connection, and I didn't make a connection either."
"I had the implant removed in March this year in England. Most of the problems have disappeared, but the pain is still there - however I feel much better than I was before."
http://www.medicalplasticsnews.com/news/medical-devices/women-meet-mps-to/
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Senior doctors call for public inquiry into use of vaginal mesh surgery in UK
Jul 18, 2017 | The Guardian
By Hannah Devlin
Senior doctors have called for a public inquiry into the use of vaginal mesh surgery amid mounting concerns that a significant proportion of patients have been left with traumatic complications.
Speaking at a meeting in parliament, Carl Heneghan, professor of evidence-based medicine at the University of Oxford, drew comparisons with the thalidomide scandal, saying that there was evidence that mesh procedures, used to treat complications from childbirth, carry significantly more risk than official figures suggest.
“With thalidomide you could see the visual representation. [With mesh] you can’t see it,” Heneghan told the meeting. “We should have a public inquiry.”
Between 2007 and 2016, more than 126,000 women in England were treated with mesh implants, tapes and slings, for urinary incontinence and organ prolapse, according to figures obtained by the Guardian.
The procedures involve inserting a plastic mesh into the vagina to support the bladder, womb or bowel. In the majority of cases these operations are quick and successful.
However, speaking at the meeting in parliament, Heneghan and Sohier Elneil, a consultant urogynaecologist at University College Hospital, said that complication rates for some types of procedure appeared to be unacceptably high, and raised questions about whether the surgery was being used inappropriately.
Elneil said that unpublished research by her team, based on Hospital Episode Statistics, suggest that urinary incontinence surgery has a readmission rate of 8.9% and that most of these patients required some form of subsequent procedure. “These are not minor complications,” she said.
By contrast, a report by the Medicines and Healthcare Products Regulatory Agency (MHRA), the government watchdog, suggested a roughly 1-2% rate of pain or “erosion” for mesh procedures related to incontinence.
Heneghan cited a recent Lancet study, which showed that the readmission rate for one form of mesh surgery for prolapse was 19% – although the figure varied depending on the type of procedure.
The meeting came as a group of patients in the UK are preparing a class action against manufacturers. David Golten, a partner at Wedlake Bell LLP, claims his firm is already representing 200 women. Previously, there have been huge payouts linked to lawsuits in the US and a major trial against Johnson & Johnson began in Australia last week.
The meeting also heard a series of harrowing testimonies from patients who had experienced life-altering complications due to surgery.
Karen Preater, 40, from Rhyl, described how she was left with intense pain after having mesh surgery to treat incontinence. “My kids don’t remember the mum from three and a half years ago. I don’t do the things I used to do,” she said. “I can categorically say, if I didn’t have my children I wouldn’t be here today.”
Carol Williams, 58, also from North Wales, broke down in tears as she told the meeting how she had been admitted to the Priory clinic after becoming suicidal due to an escalating series of complications brought about by her surgery for pelvic prolapse.
Others spoke of “cheese wire” pain, removal of organs that had become ensnared in the mesh, loss of their sex lives and the psychological toll of not being listened to by their doctors. One women said she was being treated for post-traumatic stress disorder “like a soldier coming back from Afghanistan”.
In some cases, the patients had opted for what they said was presented as a “quick fix” to treat problems that were annoying but not debilitating, such as mild urinary incontinence.
John Osborne, a retired gynaecologist, said that when the procedure was introduced in the 1990s, it was used far too liberally, in the absence of good evidence on the risks.
“Surgeons were saying ‘no problem, I can fix you up with a little mesh’,” he said. “The mesh was being put in too many people, too easily. I’m not saying that mesh should be totally banned, but not used in the numbers that it has been.”
If problems occur, having the procedure reversed is a complex and risky procedure because the mesh, which is designed to be permanent, becomes embedded in the surrounding tissue. Kath Sansom, founder of Sling the Mesh campaign, described this as like “trying to remove chewing gum from matted hair”.
The meeting in parliament was organised by Owen Smith, the Labour MP for Pontypridd, and Sling the Mesh, a campaign group that is calling for the procedure to be banned.
However, other doctors have cautioned that problems have arisen mostly due to aggressive marketing of substandard products by companies and, in some cases, inadequate training on the part of doctors.
Mark Slack, a consultant gynaecologist at Addenbrookes Hospital in Cambridge, said: “The TVT [the most common mesh procedure] is a good operation if done by the right people by the right indications,” he said.Advertisement
“We now for the first time have masses of patients coming in and saying ‘You’re not going to put mesh in me are you?’” he added. “There’s a danger of creating a massive problem.”
Alternative treatments for incontinence and prolapse also carry risks, he said – and in some cases the complication rates could be worse.
In a statement, the MHRA said: “Patient safety is our highest priority and we sympathise with women who have suffered complications after surgery.
“We are committed to help address the serious concerns raised by some patients. We have undertaken a great deal of work to continuously assess findings of studies undertaken by the clinical community over many years, as well as considering the feedback from all sources in that time.
“What we continue to see is that evidence supports the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse, in appropriate circumstances. This is supported by the greater proportion of the clinical community and patients.
“In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of a robust body of evidence wh
https://www.theguardian.com/society/2017/jul/18/senior-doctors-call-for-public-inquiry-into-use-of-vaginal-mesh-surgery-in-uk
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Invokana Amputation Injuries on the rise
Jul 19, 2017 | The Legal Examiner
By Shezad Malik MD JD
Invokana Amputation Injuries. According to the latest court lawsuit data, Invokana related serious injuries are on the rise, especially Invokana Amputation Injuries.
Injured diabetic patients have filed Invokana product liability and personal injury lawsuits against Janssen Pharmaceuticals and it’s parent company, Johnson & Johnson, claiming that the drug makers failed to adequately research the medication or warn patients and doctors about the potential health risks with Invokana.
Invokana Amputation Injuries
Invokana linked to kidney failure, urinary tract infections, leg amputations and diabetic ketoacidosis according to lawsuits.
What is Invokana?
Invokana (canagliflozin) is a new type 2 diabetic medication released in March 2013, and has been touted by Janssen Pharmaceuticals and Johnson & Johnson as being superior to the older types of diabetic medications.
Invokana increases the amount of sugar excreted in the urine. Invokana has been plagued by the FDA, who has required several Invokana warning updates.
FDA Invokana Warnings
In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, highlighting that the medication significantly increases the risk of this potentially deadly condition. Patients were advised by the FDA to stop taking Invokana and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. The FDA warning included data about severe urinary tract infections from Invokana use.
A recent study in the New England Journal of Medicine confirmed the findings.
In June 2016, the FDA required additional label warnings about the link between Invokana and kidney risks, highlighting that the medication may increase the risk of acute kidney injury.
Invokana doubles Amputation risk according to studies
Based on new data from two large clinical trials, the FDA in May 2017 concluded that the type 2 diabetes medicines Invokana, Invokamet, Invokamet XR caused an increased risk of leg and foot amputations.
The FDA is requiring new warnings, including their most prominent Boxed Warning, to be added to the Invokana drug labels to describe this risk.
Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with Invokana compared to patients treated with placebo, which is an inactive treatment.
Invokana Federal Multidistrict Litigation
Since December 2016, all federally-filed Invokana injury lawsuits have been consolidated as part of the federal Invokana multidistrict litigation (MDL), which is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey to coordinate discovery and pretrial proceedings.
If you or someone you know succumbed to an Invokana Ketoacidosis, leg amputations or kidney failure from taking Invokana for the treatment of their type 2 diabetes, please call us for further information at 888-210-9693. Dr. Shezad Malik Law Firm is investigating Invokana Ketoacidosis, leg amputations or kidney failure from taking Invokana for the treatment of their type 2 diabetes.
http://fortworth.legalexaminer.com/fda-prescription-drugs/invokana-amputation-injuries-on-the-rise/
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