Ethicon Media Monitoring 08/22/16

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1. Mesh Settlements and Pudendal Neuralgia

   Aug 21, 2016 | Mesh Medical Device Newsdesk

   You may recall earlier this year, Johnson & Johnson made an offer to settle up to 3,000 lawsuits filed by women who claim injuries from the company’s pelvic mesh.
2. Study: Autoimmune Response to Transvaginal Mesh

   Aug 21, 2016 | Mesh Medical Device Newsdesk

   A study published this month is just the latest to confirm that there is an autoimmune response some women experience after a transvaginal mesh implant. It further dispels the notion many doctors believe that vaginal mesh complications are psychological in nature and just in a woman’s head.
3. Pelvic Organ Prolapse Repair Device Industry Professional Survey, Growth, Size, Shares, Forecast, Analysis and Supply Demand to 2021

   Aug 19, 2016 | Medgadget

   By Ameya Pingaley
   
   
   The Pelvic Organ Prolapse Repair Device Market Sales Research Report is a professional and in-depth study on the current state of the Global Pelvic Organ Prolapse Repair Device industry.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. Mesh Settlements and Pudendal Neuralgia

   Aug 21, 2016 | Mesh Medical Device Newsdesk

    Mesh Settlements- Will You Say Yes?
   

   You may recall earlier this year, Johnson & Johnson made an offer to settle up to 3,000 lawsuits filed by women who claim injuries from the company’s pelvic mesh.  The $120 million settlement would result in an average amount of $40,000 to 60,000 per case with some women receiving much more and some much less.  More on the settlement’s announcement last January in a background story on Mesh News Desk here.
   While some settlements may be in the works, it raises an important question for the injured. Will you take yours? That is a question a woman diagnosed with pudendal neuralgia especially should ask.

   What is pudendal neuralgia?   It is a chronic and painful nerve condition of the pelvis.  Please read more in this excellent article written by a nurse for Mesh News Desk here.

   
   

   As for things to consider at this juncture, the following is written by Dr. Greg Vigna, JD and MD and is not sponsored copy.

    

   The Debacle Continues:  Pudendal Neuralgia Victims Caught In A Bind?
   

   As the Mesh Debacle continues the roll of the appointed Special Masters is in focus.  Both Federal and State Courts appoint a ‘special master’, to oversee the settlement administration to ensure that claims are handled fairly and efficiently within the framework of the negotiated settlements.

   Because Settlements are confidential it is impossible to understand how the Special Masters of the various Settlements are handling the ‘Linda Gross Injury’ or reliably ‘diagnosed pudendal neuralgia.’  This fact is not fair for those with the most catastrophic injury of the transvaginal mesh.

   Individual litigation provides the power of mediation where two parties weigh risk versus benefits of accepting or rejecting offers of compromise where there are well defined monitory damages for future care, past medical expenses, and wage loss that can be presented but the possibility of punitive damages are weighed by the parties.

   There are too many questions for those with diagnosed pudendal neuralgia:Can mere medical records provide the evidentiary support for adequate compensation for those suffering with pudendal neuralgia and  Complex Regional Pain Syndrome? Is the determination from the Special Master Binding for those with Pudendal Neuralgia? 

   Will there be an attorney available to proceed further after a non-binding Special Master determination is rejected by a victim suffering from pudendal neuralgia?

   Fortunately, for those who have a reliably diagnosed pudendal neuralgia with the resources to go the distance there are attorneys stepping up for those who are most injured from the TVT-O devices and Pelvic Organ Prolapse devices from AMS, Boston Scientific, and JNJ that are willing to roll on with the Settlement Lien for those with pudendal nerve injury, which are believed to be excluded from the Matrix Settlements to date.

   
   

   http://www.meshmedicaldevicenewsdesk.com/mesh-settlements-pudendal-neuralgia/
   

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2. Study: Autoimmune Response to Transvaginal Mesh

   Aug 21, 2016 | Mesh Medical Device Newsdesk

   A study published this month is just the latest to confirm that there is an autoimmune response some women experience after a transvaginal mesh implant. It further dispels the notion many doctors believe that vaginal mesh complications are psychological in nature and just in a woman’s head.  

   The research, from McGee Women’s Hospital at the University of Pittsburgh, is published in the August 2016 issue of the American Journal of Obstetrics & Gynecology.

   Twenty-seven women underwent mesh removal or excision due to pain or mesh exposure or erosion into the vagina. The explanted mesh was compared to 30 vaginal biopsy specimens from women who did not have a vaginal mesh implant.  The women who were experiencing vaginal mesh complications had an elevated inflammatory response to the transvaginal mesh medical device.

   Researchers found the excised vaginal mesh had higher levels of macrophages, a type of white blood cell that responds to a foreign body.

   An M1 is a macrophage that is proinflammatory leading to chronic inflammation and a ultimately a potential for tissue damage. A M2 macrophage remodels tissue which, if it is ongoing, can result in fibrosis and encapsulating of the mesh.

   
   

   
   

   Fibrosis is essentially scar tissue formation that causes mesh to harden, become rigid. Scar tissue formation can entrap nerves in the process. Fibrosis causeschronic inflammation and that in turn can result in the vaginal mesh shrinking up to 50 percent.

   Mesh explanted after 3 mo.

   Mesh removed because it was eroding into the vagina had an 88.4% greater response and higher number of macrophages and vaginal mesh degradation. Mesh removed because of pain had a higher number of M2 cells and was consistent with fibrosis.

   Researchers believe this bodily response can go on for years.

   The latest information about pelvic mesh is part of a growing body of research that may explain why so many women are suffering after they were implanted with polypropylene mesh to treat pelvic organ prolapse or stress urinary incontinence. Some mesh was implanted prophylactically during a hysterectomy ‘in case” there was prolapse.

   
   

   Very little was known to doctors or patients about pelvic mesh prior to it being approved for market because mesh manufactures were not required by the U.S. Food and Drug Administration to do any clinical trials. Instead vaginal mesh was allowed to be put on the market to treat pelvic organ prolapse or stress urinary incontinence in the mid 1990’s with abundant marketing promises and no research to back it up. Doctors and marketers considered accurate placement of the mesh all that was necessary to call it a success.

   We are now discovering 20 years later, that the permanent implants may elicit a permanent complication, even when they are removed or partially removed.  ##

   http://www.meshmedicaldevicenewsdesk.com/study-autoimmune-response-transvaginal-mesh/
   

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3. Pelvic Organ Prolapse Repair Device Industry Professional Survey, Growth, Size, Shares, Forecast, Analysis and Supply Demand to 2021

   Aug 19, 2016 | Medgadget

   By Ameya Pingaley

   The Pelvic Organ Prolapse Repair Device Market Sales Research Report is a professional and in-depth study on the current state of the Global Pelvic Organ Prolapse Repair Device industry.

   The report provides a basic overview of the Global Pelvic Organ Prolapse Repair Device Industry including definitions, classifications, applications and Market Sales chain structure. The Pelvic Organ Prolapse Repair Device Market Sales analysis is provided for the international Market Sales including development history, competitive landscape analysis, and major regions’ development status.

   Browse detailed TOC, Tables, Figures, Charts and Companies mentioned in Global Pelvic Organ Prolapse Repair Device Market Sales research report @ http://www.360marketupdates.com/10219939

   Next part of the Global Pelvic Organ Prolapse Repair Device Market Sales analysis report speaks about the manufacturing process. The process is analysed thoroughly with respect three points, viz. raw material and suppliers, various manufacturing associated costs (material cost, labour cost, etc.) and the actual process.

   After the basic information, the report sheds light on the production. Production plants, their capacities, global production and revenue are studied. Also, the Global Pelvic Organ Prolapse Repair Device Market Sales growth in various regions and R&D status are also covered.

   Further in the report, the Global Pelvic Organ Prolapse Repair Device Market Sales is examined for price, cost and gross. These three points are analysed for types, companies and regions. In continuation with this data sale price is for various types, applications and region is also included. The Pelvic Organ Prolapse Repair Device Industry for major regions is given. Additionally, type wise and application wise figures are also given.

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   Data by Countries having Import/Export is given:North AmericaChinaEuropeJapanIndiaSoutheast Asia

   Development policies and plans are also discussed as well as manufacturing processes and cost structures. This report also states import/export, supply and figures as well as cost, price, revenue and gross margin by regions (United States, EU, China and Japan), and other regions can be added.

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   Then, the report focuses on global major leading industry players with information such as company profiles, product picture and specification, capacity, production, price, cost, revenue and contact information. Upstream raw materials, and downstream consumer’s analysis is also carried out. What’s more, the Global Pelvic Organ Prolapse Repair Device industry development trends and Marketing channels are analysed.

    Top Key players of this industry:EthiconBard MedicalEndoBoston ScientificColoplastCovidienCook MedicalNeomedic

   For each player, product details, capacity, price, cost, gross and revenue numbers are given. Their contact information is provided for better understanding.

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   Finally, the feasibility of new investment projects is assessed, and overall research conclusions are offered. In a word, the report provides major statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the Market Sales.

   In this Pelvic Organ Prolapse Repair Device analysis, traders and distributors analysis is given along with contact details. For material and suppliers also, contact details are given. New investment feasibility analysis is included in the report.

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   http://www.medgadget.com/2016/08/pelvic-organ-prolapse-repair-device-industry-professional-survey-growth-size-shares-forecast-analysis-and-supply-demand-to-2021.html
   

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