Preview Newsletter
Ethicon 15/6
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Op-Ed – J&J Visits the White House for Women’s Summit!
Jun 14, 2016 | Mesh Medical Device News Desk
... It is with this pile of hollow, hurtful words that Johnson and Johnson Chairman and CEO Alex Gorsky joined President Obama and First Lady Michelle Obama at the White House today for the first United States of Women Summit. -
Boston Scientific updates warnings for pelvic mesh products
Jun 14, 2016 | Mass Device
By Fink Densford
Boston Scientific (NYSE:BSX) recently updated the directions for use and warnings for its pelvic mesh products, classifying the meshes as permanent implants and warning of complications related to removals. -
Boston Scientific adds new warnings to surgical-mesh devices
Jun 14, 2016 | Star Tribune
By Joe Carlson
Boston Scientific Corp. is adding new safety warnings to the labels for its most heavily litigated products — surgical-mesh devices used to repair common pelvic disorders in women.
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Op-Ed – J&J Visits the White House for Women’s Summit!
Jun 14, 2016 | Mesh Medical Device News Desk
Johnson & Johnson (J&J) strives to live up to its creed everyday. The following is an Op-Ed by the editor of MND who has sat in a number of trials watching the company in its support of women.
The J&J Credo is that its first responsibility is to“the doctors, nurses and patients, to mothers and fathers and all others who use our products and services.”...It goes on,” We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens- support good works and charities and bear our fair share of taxes…”
“At Johnson & Johnson, we believe family comes first…….”
It is with this pile of hollow, hurtful words that Johnson and Johnson Chairman and CEO Alex Gorsky joined President Obama and First Lady Michelle Obama at the White House today for the first United States of Women Summit.
Topics included economic empowerment, gender equality, health and wellness and educational opportunities for women.
I think of the women injured by mesh. Empowered? No, stripped of their humanity would be more accurate. Economically, many have lost their homes, the homes they worked for. Educational opportunities? Most mesh injured women can hardly hold jobs must less pursue an education. Gender equality? Both men and women are adversely affected by polypropylene mesh made by J&J.
Linda Gross in NJ trial, Feb 2013, Implanted with Prolift
Health and wellness? The pages of Mesh News Deskand the thousands of women online are a testament to the attack on their health by an untested experimental medical device. The fact that the company has more pelvic mesh product liability lawsuits than any other is a testament to its credo. The fact that it continues to pay deep pocketed law firms thousands of dollars an hour to fight injured women and families in court is another testament to the humanity of this company and its credo.
“…we believe families come first”
J&J Shareholders meeting protest 2014
J&J is the same company that rushed the Prolift to market without any notification to the FDA. It didn’t think it had to. Polypropylene suture was already approved and the Prolift was just a lot of suture threads, right? J&J is the same company that failed to re-issue its Instructions for Use when one of its own scientists said the warnings were insufficient. The pamphlet had already come back from the printer, we’ll get it next time, the company said.
J&J conveniently destroyed hundreds of thousands of pages of documents pertaining to mesh litigation even when there was a hold on those documents. Sweep clean any executive hard drives when they got reassigned, as they often did.
J&J is the same company behind one of the power morcellators that grind and spread an aggressive form of uterine cancer and body powder that’s now the focus of litigation by women with cancers or the family members they left behind. Washington State and California just launched a probe into fraudulent marketing by J&J of its pelvic mesh products.
Protest in Charleston WV fed court
The public relations division of J&J can gloss over those facts during a Woman’s summit but to state J&J has “an extensive history of supporting women and mothers worldwide...” is almost more than anyone can take. Think of the children who no longer have mothers who can care for them or grandmothers who can pick them up. Here is the agenda.
When J&J and its Ethicon division finally agrees to settle outstanding mesh cases, about 50,000 at last count in the U.S. alone, with a lifetime of care, that will be one important way to address theState of Women who had no choice in the use of its pelvic mesh products.
http://www.meshmedicaldevicenewsdesk.com/jj-alex-gorsky-visit-white-house-family-day/
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Boston Scientific updates warnings for pelvic mesh products
Jun 14, 2016 | Mass Device
By Fink Densford
Boston Scientific (NYSE:BSX) recently updated the directions for use and warnings for its pelvic mesh products, classifying the meshes as permanent implants and warning of complications related to removals.
The Marlborough, Mass.-based company added new precautions to the directions for the meshes, warning that that “regardless of the route of delivery,” the meshes have been associated with “erosion” which may require surgical removal.
“Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications,” the company wrote in its updated guidelines.
Adverse event risks associated with the device were updated to include that perforation or laceration of vessels, nerves, bladder, urethera or bowel may occur during placement. Scarring, scar contracture and ongoing pain were also added to the list of possible adverse events.
The company also warned that “In some instances the response to these events may persist as a permanent condition after the intervention,” according to the press release.
Risk factors which “impact patient outcomes” with the devices were also updated to included impaired vascularity, such as diabetes or smoking, age, pelvic floor myalgia, impaired wound healing or active infections at the surgical site.
Boston Scientific said these factors, as well as issues with untreated coagulopathies and patients with hypertonic bladders or vesico ureteral reflux should be taken into consideration before performing procedures with the devices.
Last October, Boston Scientific saw its $100 million payment over a lost pelvic mesh lawsuit slashed to $10 million by a Delaware judge.
Judge Mary Johnston in New Castle County, Delaware, said that the damages awarded to plaintiff Deborah Barba last May – the largest ever in a trial involving transvaginal mesh – were “grossly disproportionate to the injuries suffered and shock the court’s conscience and sense of justice.”
But Johnston denied Boston Scientific’s bid to set aside the verdict altogether and order a new trial. While the jury had properly decided the company’s liability, Johnston wrote in her ruling that the jury’s award was too high, particularly in comparison with the other mesh trials, in which punitive damages awards spanned from $1.75 million to $7.76 million.
http://www.massdevice.com/boston-scientific-updates-warnings-pelvic-mesh-products/
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Boston Scientific adds new warnings to surgical-mesh devices
Jun 14, 2016 | Star Tribune
By Joe Carlson
The company faces more than 36,000 product liability cases related to the devices.
Boston Scientific Corp. is adding new safety warnings to the labels for its most heavily litigated products — surgical-mesh devices used to repair common pelvic disorders in women.
Boston Scientific, like other med-tech companies that operate in Minnesota, is facing thousands of lawsuits from women who say they were injured when their implanted pelvic meshes and slings became infected or created erosion of the surrounding tissue. On Tuesday, the company said it is adding “erosion” and “ongoing pain” to the list of warnings and precautions disclosed on device labels worldwide.
The labels will now say that meshes and slings are considered permanent implants, that removal may be complicated or impossible, and that the treatment for post-surgical device erosion may require surgical removal of the device.
Transvaginal slings are implanted to treat stress urinary incontinence, while surgical meshes are used to strengthen tissue in patients with pelvic organ prolapse.
A study of 10 million women, published last year in the journal Obstetrics & Gynecology, estimated that the lifetime risk of having surgery for either of the conditions is about 20 percent by the age of 80.
The changes to the device labels, which were implemented in May and announced Tuesday, affect five Boston Scientific brands of transvaginal slings (Advantage, Lynx, Obtryx, Obtryx II and Solyx) and three types of mesh (Uphold LITE, Pinnacle LITE, and Upsylon Y).
The changes were announced in “urgent” advisory letters sent last month to doctors worldwide. The company letters were followed by announcements from regulators in Europe publicizing the changes.
The devices are not being recalled, and there was no request to have devices sent back to the company. The notice says there is no impact to previously implanted devices. A company spokesman said the changes were prompted by a review of data by company officials and medical device regulators in Australia, and that the updated label disclosures will be added to other manufacturers’ devices as well.
As of May 2, Boston Scientific was facing more than 36,000 product liability cases related to the devices, with plaintiffs asserting flaws in design and manufacturing, failure to warn of known dangers, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium claims.
Securities filings say the company has entered agreements to settle about 11,000 of the cases so far, without any admission of liability or wrongdoing. The company has also responded to written information requests about the devices from state attorneys general.
http://www.startribune.com/boston-scientific-adds-new-warnings-to-surgical-mesh-devices/383036211/
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