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Ethicon Media Monitoring 5/17/2018
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Boston Scientific comes under pressure over allegations it used counterfeit plastic to produce vaginal mesh
May 16, 2018 | Medical Plastics News
A 60 Minutes report by CBS has resurfaced claims that medical device giant, Boston Scientific, used counterfeit plastic to produce its vaginal mesh products. -
Ethicon MDL Trial Delay Till August
May 16, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
What happened to the Ethicon, (Johnson & Johnson) product liability trial that was supposed to start in Charleston, West Virginia in May? -
Limerick solicitor claims lives are being destroyed in latest health service scandal
May 16, 2018 | Limerick Post
By Bernie English
A LIMERICK solicitor is highlighting the case of Irish women who claim their lives have been ruined by a medical device designed to stop incontinence by leading a protest to the Dáil this Thursday. -
The lies patients need to stop telling their doctors
May 16, 2018 | The Sydney Morning Herald
By Heather Doyle
Whether it's out of embarrassment, fear of being judged or simple ignorance, plenty of patients lie to their doctors. What a patient believes to be a simple fib, however, could be downright dangerous to their health.
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May 16, 2018 | Medical Plastics News
A 60 Minutes report by CBS has resurfaced claims that medical device giant, Boston Scientific, used counterfeit plastic to produce its vaginal mesh products.
The report uncovered emails suggesting that Boston Scientific bought counterfeit polypropylene from a supplier in China, so it could continue to produce its devices.
Boston Scientific was previously using a Texas-based subsidiary of Chevron Phillips to buy a brand of polypropylene called Marlex.
However, the report indicates that Chevron Phillips cancelled its supply partnership with Boston Scientific, after it became concerned about the use of Marlex within the human body.
Chevron Phillips even issued a warning stating Marlex must not be used for permanent implant within the human body.
With its deal with Chevron Phillips cancelled, Boston Scientific estimated that its current supply of Marlex would run out by 2012.
The company was worried as the FDA had approved its vaginal mesh products on the basis that it was using Marlex to manufacture the devices.
After a second supplier refused to sell Marlex to Boston Scientific in 2010, the company found a broker in China who could supply it with Marlex.
The supplier, Emai Plastic Raw Materials, apparently told Boston Scientific that if had a large supply of Marlex that it had imported from Chevron Phillips.
The 60 Minutes report cites court documents revealing that Boston Scientific management told an employee in China not to tell Emai where the material would be used as “it could scare them away”.
More so, Emai did not have the correct documentation to prove that its material was in fact Marlex.
After a number of checks on the bags it had purchased from Emai, alongside confirmation with Chevron Phillips, Boston Scientific found that the bags were fraudulent and that the packaging was fake.
Boston Scientific then tested 11 parameters of the material it had obtained from Emai in comparison to Chevron Phillips’ Marlex.
The company found that only two parameters were the same and that four of those were classed as 'very different'.
However, the company went on to conclude that the two materials were the same and bought 30 years’ worth of supply from Emai, 60 Minutes state.
The 60 Minutes report features commentary from a number of plastics experts and surgeons who have been involved in the removal of mesh in women.
Plastics engineer, Chris DeArmitt, who researched Boston Scientific for one of the women suing the company, said: “I would say the material they're buying maybe is fine for making a park bench. Maybe it's fine for making a disposable cup. But that's a totally different situation when you're looking at something that will be in the body for 40 or 50 or 60 years. There's a whole different level of analysis and confidence that you need. And I don't see that here".
Boston Scientific responded to the 60 Minutes report, issuing a statement on its website, signed off by chairman and CEO Mike Mahoney and executive vice president Urology and Pelvic Health, Dave Pierce. “The broadcast resurfaced outdated and previously disproven allegations first made by attorneys in 2016. Our rigorous testing and investigation have shown that the resin currently used in our products matches a formulation from the original U.S. produced resin. This information was also reviewed by the U.S. Food and Drug Administration (FDA) and was part of the basis of its conclusions.
“The show offered a one-sided view and commentary from clinicians and plastic experts involved with litigious actions. It is important to keep in mind that polypropylene-based (plastic) devices have been a mainstay in many medical procedures for more than 50 years, including hernia and tendon repair, sutures, and wound closure. Furthermore, our products meet rigorous internal safety standards, international standards, as well the standards of the FDA and other regulatory bodies.” The company states.
https://www.medicalplasticsnews.com/news/boston-scientific-comes-under-pressure-over-allegations-it-u/
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Ethicon MDL Trial Delay Till August
May 16, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
What happened to the Ethicon, (Johnson & Johnson) product liability trial that was supposed to start in Charleston, West Virginia in May?
Ethicon MDL Trial Delay Till August
You might have heard the terms Wave 7, which is a grouping of plaintiffs with a similarity, that is, similar pelvic mesh, in this case, or all from West Virginia, for example.
Well, there has been a delay.
In Pretrial Order (PTO)#296, issued by Judge Goodwin on May 1, has chosen 150 cases involving West Virginia plaintiffs to be grouped into a “wave” and worked up for trial.
The pace is a slow one but a trial date has been set.
Pretrial conferences will begin August 1 of this year in Charleston, the site of multidistrict mesh litigation.
Trial should begin August 14th at 8:30 am in the US District Court for the Southern District of West Virginia.
In PTO #291, Judge Goodwin sets deadlines for that wave. Pretrial order #298 was filed by Judge Goodwin Tuesday, May 15th. In it, he lays out a schedule to take the remaining Wave 7 and Wave 8 cases to court in Charleston, WV in the MDL.
CLEAR THE DOCKET
Previously Judge Goodwin had granted Ethicon’s motion to clear the docket of non- revision TVT cases, that is, women who have not had any attempts to have the mesh removed. There might be a good reason she’s not had a revision or removal.
Perhaps her health is compromised and she can’t undergo anesthesia. She may not have insurance or access to a doctor who recommends removal.
To be defined as a revision surgery the woman must undergo general, regional or MAC anesthesia.
None of that matters. Ethicon wants to rid the court of non-revised cases.
“Ethicon position is, in part, that such Non-Revised Plaintiffs do not currently have cognizable claims against it because they have not had a “Revision Surgery,” writes Judge Goodwin.
See MND on what Ethicon was granted here.
Meshes in the TVT family include TVT Retropubic, or Abdominal, TVT Obturator, TVT Abbrevo, TVT Exact. Four devices which are no longer marketed are also included such as Prolift, Prolift +M, Prosima and TVT-Secur.
The TVT family also includes Gynemesh PS and Prolene, the proprietary name of Ethicon (J&J’s) polypropylene mesh.
Because their case is filed without prejudice, the thousands of women in this group have five years to either have surgery or undergo a similar gynecological procedure and they can refile their cases.
Judge Goodwin writes non-revised plaintiffs need to file an election form by July 10, 2018 to either dismiss her case without prejudice or to continue her case.
The Order gives the deadlines that follow for the rest of 2018.
Motions must be filed by December 3, and expert daubert expert motions by December 18. After that the cases will either be placed on trial or remanded to the proper venue of a federal district court.
Judge Goodwin has previously articulated that he wants this MDL before him resolved and that neither side would be happy with that compromise.
https://www.meshmedicaldevicenewsdesk.com/ethicon-mdl-trial-delay-till-august/
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Limerick solicitor claims lives are being destroyed in latest health service scandal
May 16, 2018 | Limerick Post
By Bernie English
A LIMERICK solicitor is highlighting the case of Irish women who claim their lives have been ruined by a medical device designed to stop incontinence by leading a protest to the Dáil this Thursday.
Dooradoyle-based Melanie Power says the women have been left in excruciating pain, lost their jobs, left needing walking aids or, in extreme cases, being confined to beds or wheelchairs following operations to insert plastic pelvic mesh that cannot be removed in this country.
She has organised the Mesh Survivors Ireland group and has spearheaded the national campaign to suspend the use of pelvic mesh in Ireland until the womens’ claims can be fully investigated.
“Transvaginal mesh devices are used in surgeries to treat stress urinary incontinence and pelvic organ prolapse. The device contracts in the pelvic area bringing with it nerves, tissues and slicing like cheese wire into whatever organs get in the way,” Ms Power told The Limerick Post.
https://www.limerickpost.ie/2018/05/16/limerick-solicitor-health-service-scandal/
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The lies patients need to stop telling their doctors
May 16, 2018 | The Sydney Morning Herald
By Heather Doyle
"My injury isn't sex related."
"I don't smoke that much."
"These are the only medications I take."
Whether it's out of embarrassment, fear of being judged or simple ignorance, plenty of patients lie to their doctors. What a patient believes to be a simple fib, however, could be downright dangerous to their health.
Here are a few statements doctors wish their patients would stop saying in their office.
"This is not a sex injury."
"Patients often lie about medical conditions or diagnoses that arise during private or embarrassing situations, especially anything sexually related," says Dr. Sanjey Gupta.
"When patients lie, even if we confront them, it is difficult to provide them the proper care or to help ensure them a safe discharge," he said.
These situations can be worse when an ailment was caused by abuse, Gupta says. In these cases, the patient may not only be misdiagnosed and mistreated, but also return to a dangerous environment.
"I don't take any supplements."
Vitamins and supplements can skew test results and impact a doctor's diagnosis, according to Dr. Sunil Soodl.
Many herbal supplements or over-the-counter medications "have active compounds that may interfere with the medications that we are attempting to prescribe," said Gupta.
"Neither do my kids."
While accounting for supplements is important for treating adults, the issue is particularly important when it comes to diagnoses for children.
"Parents are unwittingly hiding something from us" because they "think it's normal," said Sood. "They don't mention the vitamins, probiotics or supplements when they list the medications their children are taking."
In reality, "none of these are necessary to give to children", he said.
"I don't smoke very often."
Patients don't just lie about smoking. They also underestimate how much they smoke, believing it's not enough to cause their other health problems, according to Dr. Puneet Gandotra.
"They may not feel that their heart disease or peripheral arterial disease is due to their habit," Gandotra said, noting that smoking is one of the leading causes of heart-related incidents.
"Patients may feel ashamed of their usage or do not want to discuss their habit" he said. "It is imperative to know this information to diagnose and treat and prevent further events."
"I don't have diabetes."
"Diabetes is a risk for complications from a surgical wound, and it could dictate which way you manage the patient's recovery," says Dr. Adam Bitterman.
This goes for any condition, whether it's diabetes, cardiovascular disease or an ankle injury.
"All should be openly and fully disclosed," he adds. "No piece of medical history is too trivial to mention."
"I don't eat that much."
"People tend to underestimate food consumption. We all do," said Christine Santori, a registered dietician and program manager for Weight Management.
Those who are trying to focus on their nutrition may disregard what they take in from smoothies, alcohol and other beverages, says Santori.
"They think it isn't important, but they may be missing those calories by just focusing on the food they eat."
"Everything is fine in the bathroom."
Unless specifically asked, he said, many women can feel embarrassed about leaks, having to wear pads or change their clothes several times a day.
"They often also feel there is no safe treatment," he said, particularly when it comes to the vaginal mesh, on which there is an abundance of false information.
"Women frequently say to me, 'I am not going to have that mesh surgery that is on TV all the time,'" said Finamore. "The truth is there are nonsurgical treatments as well as surgical treatment."
https://www.smh.com.au/lifestyle/health-and-wellness/the-lies-patients-need-to-stop-telling-their-doctors-20180516-p4zfqw.html
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