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Ethicon Media Monitoring 07/22/16
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Ethicon Says Professor Unfit To Testify In Pelvic Mesh MDL
Jul 21, 2016 | Law 360
By Steven Trader
Johnson & Johnson unit Ethicon on Wednesday urged the West Virginia federal judge overseeing multidistrict litigation regarding its pelvic mesh products to nix an expert who was prepared to testify on the products’ allegedly poor quality and degradation, saying he is unqualified and unreliable. -
January Pelvic Mesh Trial Set for New Jersey, Smith v. Ethicon
Jul 21, 2016 | Mesh Medical Device News Desk
It’s been a very long time since there was a pelvic mesh product liability trial in New Jersey. -
Warnings Added to Transvaginal Mesh Labels
Jul 20, 2016 | News Inferno
By Mara Lepmanis
For approximately 15 years, transvaginal mesh (TVM) products have been used worldwide, usually to treat pelvic organ prolapse (POP) and stress urinary incontinence problems in women. Since that time, 27 clinical studies have shown that one in 12 women have suffered TVM complications. It has been estimated that 50 percent of women will have some degree of POP by the age of 50 and more than 10 percent will require surgery by the age of 80. -
Column To Focus on New Medical Technologies
Jul 21, 2016 | General Surgery News
By Victoria Stern
Surgeons are bombarded with thousands of new medical technology innovations each year. Given the sheer volume of devices, “it is very difficult for new surgeons to tease out the good from the fad,” said Patricia Sylla, MD, associate professor of surgery in the Department of Colorectal Surgery, Mount Sinai Hospital, in New York City. “Even more seasoned surgeons have a hard time.” -
5 Bathroom Mistakes That Can Lead To Pelvic Floor Dysfunction
Jul 22, 2016 | Huffington Post Canada
By Cassie Dionne,
Today I want to talk about something that not everyone feels comfortable talking about, but something that is incredibly important and that is your toileting behaviours!
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Ethicon Says Professor Unfit To Testify In Pelvic Mesh MDL
Jul 21, 2016 | Law 360
By Steven Trader
Johnson & Johnson unit Ethicon on Wednesday urged the West Virginia federal judge overseeing multidistrict litigation regarding its pelvic mesh products to nix an expert who was prepared to testify on the products’ allegedly poor quality and degradation, saying he is unqualified and unreliable.
Ethicon is seeking to exclude the testimony of the Dr. Russell Dunn, a professor in the department of chemical and biomolecular engineering at Vanderbilt University, who the company claims is prepared to testify on behalf of the patients that the Prolene mesh used in a number of Ethicon’s pelvic mesh products undergoes hazardous oxidative degradation in the body, and that Ethicon’s quality system for these devices failed to comply with industry standards.
The problem, Ethicon argued, is that Dr. Dunn has zero experience with medical devices and admits that he is not an expert in biomaterials. What’s more, Dr. Dunn has never been involved in the design, quality control or any aspect of risk management of any medical device, has no experience with the medical industry standards that his opinions focus on and in fact “has a serious misunderstanding of those standards,” Ethicon wrote.
Perhaps most importantly though, the company pointed out, is that on at least 24 occasions, the West Virginia court overseeing polypropylene pelvic mesh cases has held that Dr. Dunn is not qualified to offer the opinions he intends to offer here, Ethicon said.
“This court has previously and repeatedly held that Dr. Dunn lacks the requisite qualifications to offer opinions regarding medical devices,” Ethicon wrote. “Nothing has changed regarding Dr. Dunn’s dearth of experience, and the court should yet again exclude Dr. Dunn from opining regarding polypropylene pelvic mesh devices.”
There are about 23,000 suits against Ethicon and J&J in the MDL, which covers allegations that its mishandling of transvaginal surgical mesh devices caused serious injuries to patients. The cases also claim Ethicon and related entities failed to provide appropriate warnings and instructions regarding the risks and dangers posed by the devices, which are used to treat pelvic organ prolapse and stress urinary incontinence.
The subjects of Dr. Dunn’s testimony are the Prolift, Prolift+M and Prosima mesh products, and he allegedly plans to testify that the Prolene mesh constituting those degrades within the body, that the oxidative degradation is a hazard that cannot be eliminated, and that Ethicon’s quality system and risk management is deficient because it did not eliminate this “hazard,” the court document reads.
But “Dr. Dunn concedes he has no expertise to opine whether oxidative degradation of Prolene in the body has the potential to cause any harm,” Ethicon wrote. “Dr. Dunn has no expertise relating to biocompatibility. In fact, he does not even know what a biocompatibility risk assessment is.”
What’s more, while he offers an opinion that Ethicon’s quality systems are “inadequate,” he has no experience in maintaining or even auditing a quality system for a medical device, Ethicon wrote.
Last month, the Ethicon patients sought to exclude the testimony of a polymer scientist who they said directly contradicted previous testimony by an Ethicon corporate representative who allegedly admitted that the company knew for several years that its mesh devices can crack.
Seven separate MDLs comprising 70,000 cases are pending in West Virginia over the allegedly defective products. The U.S. Food and Drug Administration recently reclassified pelvic mesh devices like those at issue in the suits as high-risk devices that must undergo the agency's most stringent safety evaluation before hitting the market.
The Fourth Circuit in April affirmed a lower court's ruling that a case thrown out of another MDL over pelvic mesh devices was barred by a two-year statute of limitations, finding that the woman should have begun questioning the mesh's effectiveness by at least the end of 2007.
The three-judge panel said in an unpublished opinion that plaintiff Brenda L. Robinson's claims, as well as her husband's derivative claims, came too long after the expiration of Utah's two-year statute of limitations for product liability actions. Robinson's case was cut from the MDL afterBoston Scientific Corp., which made the mesh, won summary judgment last year.
A representative for the patients didn't immediately return a request for comment.
The patients are represented by Bryan F. Aylstock and Renee Baggett of Aylstock Witkin Kreis & Overholtz PLLC and others.
Ethicon is represented by Christy D. Jones of Butler Snow PLLC and David B. Thomas ofThomas Combs & Spann PLLC.
The case is In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, case number2:12-md-02327, in the U.S. District Court for the Southern District of West Virginia.http://www.law360.com/articles/819893/ethicon-says-professor-unfit-to-testify-in-pelvic-mesh-mdl
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January Pelvic Mesh Trial Set for New Jersey, Smith v. Ethicon
Jul 21, 2016 | Mesh Medical Device News Desk
It’s been a very long time since there was a pelvic mesh product liability trial in New Jersey.
The first case was Linda Gross v Ethicon held February 2013, which resulted in an $11.1 million verdict for Ms. Gross which is still on appeal, though near the end of the process.
After Wednesday’s Case Management conference, now another trial has been set for January 9, 2017 in the Superior Court of New Jersey Law Division, Bergen County, New Jersey. This is a state court where trials are conducted.
Smith v Ethicon is set for that date. Ms. Smith was implanted with a TVT-O and the case is still in the discovery stage. Case No. 16720-14.
Bard trials, though not scheduled should begin to be set for early 2017, according to the Case Management Order. At the same time it’s reported that Bard continues to make settlement progress in the New Jersey multidistrict litigation MDL.
A trial is tentatively set for March 20, 2017 in the Cook, Nelson or Sheppard lawsuits filed against Ethicon for itsTVT Secur pelvic mesh.
The next date for Case Management is August 24, 2016.
Judges Rachelle L. Harz is overseeing Ethicon/ J&J and Judge James J. DeLuca is overseeing the CR Bard litigation.
There are 1,024 Bard cases filed in this jurisdiction and 8,887 cases filed naming Ethicon.
Here is the Gynecare Counsel list.
Here is the Bard Counsel list.
See the New Jersey Pelvic Mesh Home page here:
http://www.judiciary.state.nj.us/mass-tort/pelvicmesh/index.htmlApril 12, 2016 Case Management Order #27 talks about other cases being readied for trial.
http://www.meshmedicaldevicenewsdesk.com/january-pelvic-mesh-trial-set-new-jersey-smith-v-ethicon/
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Warnings Added to Transvaginal Mesh Labels
Jul 20, 2016 | News Inferno
By Mara Lepmanis
For approximately 15 years, transvaginal mesh (TVM) products have been used worldwide, usually to treat pelvic organ prolapse (POP) and stress urinary incontinence problems in women. Since that time, 27 clinical studies have shown that one in 12 women have suffered TVM complications. It has been estimated that 50 percent of women will have some degree of POP by the age of 50 and more than 10 percent will require surgery by the age of 80.
Boston Scientific, which includes five brands of TVM slings, has added safety labels stating the pelvic meshes and slings are considered permanent implants and that removal can be complicated or impossible reports LawyersandSettlements.com.
The U.S. Food and Drug Administration (FDA) warned doctors twice. Once in 2008 and again, in 2011, with a stronger warning regarding mesh treatment for POP.
Johnson & Johnson (J&J) alone sold 787,322 of its Ethicon TVM devices between 2008 and 2014 in the United States. Approximately 42,000 were sold in California, resulting in its latest lawsuit. One lawsuit against J&J is for alleged false advertising and deceptive marketing of its transvaginal mesh products, reports LawyersandSettlements.com.
American Medical Systems (AMS) is facing about 46,000 lawsuits. AMS was the first TVM manufacturer to resolve its product liability cases and closed its facility that sells the devices.
Boston Scientific is facing over 36,000 liability cases and their warning has come too late for too many women. A number of women have reported that their doctors said the mesh was the best thing since sliced bread and their problems “are all in your head.” Some patients blame their surgeons for mesh complications and were generally insufficiently informed about the risks involved with transvaginal mesh products.
The number of TVM lawsuits has now increased to more than 100,000 in the United States and over 135,000 worldwide, LawyersandSettlements.com reports.This entry was posted in Defective Medical Devices, Health Concerns, Transvaginal mesh.
http://www.newsinferno.com/warnings-added-to-transvaginal-mesh-labels/
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Column To Focus on New Medical Technologies
Jul 21, 2016 | General Surgery News
By Victoria Stern
Surgeons are bombarded with thousands of new medical technology innovations each year. Given the sheer volume of devices, “it is very difficult for new surgeons to tease out the good from the fad,” said Patricia Sylla, MD, associate professor of surgery in the Department of Colorectal Surgery, Mount Sinai Hospital, in New York City. “Even more seasoned surgeons have a hard time.”Navigating this terrain is especially tricky given that many new medical devices are simply upgrades or tweaks to existing products—a twist on a hernia mesh or trocar, for example—while fewer and fewer seem to be truly novel ideas.
Barriers to innovation exist partly because the FDA’s process for approving or clearing devices has become increasingly complex and expensive. As reported in the November 2015 issue of General Surgery News, the FDA medical device process can take years to navigate and cost companies anywhere from $30 million to $100 million, depending on the pathway required for approval. These regulations are in place to protect patients from harm, but they can also make it more difficult to invest in innovation. Even big, well-established medical device companies may find it impractical or undesirable to pursue novel ideas given the financial resources and time required to move a technology from the bench to the bedside.
The appetite to support early innovation has certainly been tempered in recent years,” said Frederick St. Goar, MD, FACC, director and vice chairman of the Fogarty Institute for Innovation, in Mountain View, Calif.
Despite these obstacles, the need for innovative technologies is great. That is why a handful of foundations have emerged to foster the development of novel, potentially high-impact technologies. The Fogarty Institute, in particular, has dedicated itself to helping startup companies develop surgical tools that can enhance doctors’ ability to diagnose and treat diseases and predict outcomes.
“We are not looking for another stent or suture device; we are looking for ideas that can have a large-scale impact on our health,” Dr. St. Goar said. Such technologies could ultimately improve patient health and lower health care costs.
The Fogarty Institute, established in 2007 by the prominent cardiovascular surgeon Thomas J. Fogarty, MD, PhD, houses a selected group of startup companies in dedicated spaces on the El Camino Hospital campus. The Fogarty Institute provides companies with resources, financial support and mentorship to get their ideas off the ground. Companies also receive guidance from physicians and industry professionals. This collaborative environment allows companies to tailor their device, address problems and pilot their technology in the clinical setting.
“The ultimate goal of the Fogarty Institute is to help startup companies move further down the approval pathway and prevent important ideas from dying on the vine,” Dr. St. Goar said.
Several companies that have graduated from the Fogarty Institute now have commercially available devices. HeartFlow, for instance, created a noninvasive test to help physicians diagnose coronary artery disease, and Niveus Medical Inc. developed a muscle stimulation system to electrically stimulate the quadriceps in order to prevent atrophy and increase range of motion. Both companies received FDA 510(k) clearance to market their products.
In this new column, General Surgery News plans to mirror the goals of the Fogarty Institute and similar foundations, such as the Biodesign Fellowship program at Stanford University and Thiel Foundation’s Breakout Labs. The column will focus on medical devices that address an unmet clinical need or have the potential to significantly improve how we diagnose or treat diseases. Each column will be centered on one technology that could, if proven effective, influence practice and patient health in important ways.
Of course, cautious optimism is warranted. The devices featured here will still be in the early stages of testing. Only time and clinical data will determine their true value. But by highlighting novel technologies, the column aims to provide a glimpse into what’s possible.
http://www.generalsurgerynews.com/Technology/Article/07-16/Column-To-Focus-on-New-Medical-Technologies/37044
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5 Bathroom Mistakes That Can Lead To Pelvic Floor Dysfunction
Jul 22, 2016 | Huffington Post Canada
By Cassie Dionne,
Today I want to talk about something that not everyone feels comfortable talking about, but something that is incredibly important and that is your toileting behaviours!
You may be wondering what exactly that means, and simply put when I say your toileting behaviours I am referring to what you do when you need to go to the bathroom and then what you do while you are going to the bathroom.x
The reason I want to talk about this today is because believe it or not our behaviours surrounding toileting can oftentimes lead to pelvic floor dysfunctions, including urinary and/or fecal incontinence, pelvic organ prolapse, pelvic pain, not to mention decreased muscular strength, endurance and coordination of the pelvic floor muscles.
Below I outline five behaviours that you likely had no idea could lead to dysfunction (I know I didn't prior to becoming a pelvic health physiotherapist). Take a read through and feel free to comment below with any questions!
1. Delaying It Too Long
We've all been guilty of this, I'm sure. Life gets busy and the next thing you know you haven't been to the bathroom in hours! Once and awhile this is OK, but if you do this frequently (as I often hear from clients who are teachers) what happens is the bladder stretches out in order to hold more urine. This overstretching leads to what is called an atonic bladder -- in other words, a bladder that lacks tone. As you can imagine this effects how well you're able to store and empty your urine, not to mention the state of your pelvic floor.
If you find yourself delaying toileting too long, try to make a conscious effort not to. A normal voiding schedule is every two to four hours. In fact, did you know that movies are designed to be around the two-hour mark so that most people could watch the full movie without having to get up to go to the bathroom?
2. Hovering Over The Toilet (I.e Not sitting your butt down on the seat!)
I know a lot of people hate to use public restrooms so they hover over the seat instead of sitting their butt down. It seems logical, but the truth is that hovering or squatting over the toilet is not good for your pelvic floor. When we are on the toilet urinating or defecating, our pelvic floor should be relaxed. By hovering you are not allowing adequate relaxation of these muscles which leads to a number of compensations. Many muscles must engage to hold you up, but without the pelvic floor muscles relaxing, the bladder and bowel don't fully empty which leads to a host of issues other than simply a weakened pelvic floor (including infections, urgency, incontinence and/or prolapse).
If you are someone that just really hates to sit on a public toilet, you can combat this by using seat covers or by making your own seat cover with toilet paper.
3. Bearing Down To Initiate Or Complete The Stream Of Urine Or During Defecation
This one is pretty simple. By bearing down to initiate or complete the stream or urine or during defecation you are essentially pushing down on the pelvic floor. This can cause stretch and strain on the muscles, further weakening them.
One of my favourite pelvic floor quotes that I have heard is "They call it a restroom for a reason." Take your time so you feel less inclined to bear down. And if you are someone who struggles with chronic constipation, then there are effective strategies you implement including dietary management and/or using a better toilet system, such as the Squatty Potty.
4. Not Allowing Time for Full Bladder Emptying
This point is very similar to the previous two in how they affect your pelvic floor. Remember, it is called a restroom for a reason, and if you don't allow time for your full bladder to empty you are faced with potential issues, as mentioned above in the second point, including infections, urgency, incontinence and prolapse. So take your time in the bathroom, and if you find yourself struggling to fully empty your bladder without straining then speak to a pelvic health expert who can help determine why that is the case and how to change it!
5. Voiding "Just in Case," Or Preventative Voiding
This behaviour was probably my biggest "ah ha" moment when I was training to be a pelvic health physiotherapist. Why? Because I, and so many people I know, do this ALL THE TIME! In fact, I had never considered how it might affect our pelvic floor and health in general, but the truth is it really does!
Essentially what "Just in Case" voiding is, is when you go to the bathroom before you need to, for example before you head out on a road trip or a hike, or leave the house just in case you might have to go later. The reason this is a habit that needs to be eliminated is that it encourages your bladder to only hold small volumes and the more you do it the more you will get the urge to urinate when the bladder is only filled with a small amount of urine.
To avoid this, simply wait to use the bathroom until you truly need to!
http://www.huffingtonpost.ca/taylored-training-fitness-/pelvic-floor-dysfunction_b_11109494.html
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