U.S. District Judge Joseph R Goodwin  set the trial date for the first of about 600 federal court cases against C.R. Bard’s Avaulta surgical mesh device.  On February 5, 2013 hundreds of women who have suffered from organ damage, tissue erosion, and other painful complications caused by mesh implants will finally have the chance to seek justice.  Check out the article below for more information on other mesh claims and which attorneys were appointed to the Plaintiffs’ Steering Committee:

http://www.bloomberg.com/news/2012-05-02/bard-faces-first-federal-trial-over-vaginal-mesh-next-year-1-.html

Check out Jane Dowdall’s story about her experience with surgical mesh on Jane Akre’s site below:

CLICK HERE 

When Johnson and Johnson’s new CEO Alex Gorsky begins his reign tomorrow he plans for the company to continue growing and wants to focus on getting the recalled drugs and medical products safely back on shelves.  In the face of many lawsuits against the company, including those regarding transvaginal mesh, Gorsky knows that he will have to work to get the company back on track.  Check out the article below for more information:
http://www.bloomberg.com/news/2012-04-25/j-j-ceo-gorsky-says-company-will-grow-while-rivals-shrink.html

Despite the lawsuits against manufacturers, the FDA’s recent warnings,  and the serious risks and complications associated with surgical mesh implants, researchers anticipate an increase in its use in 2012.  Unfortunately,  this market growth is due mainly in part to the physicians and doctors who believe the benefits outweigh the risks. The best thing consumers and patients can do is reasearch the products in question and be sure to make an educated decision when faced with the choice to use mesh or not. Please see the article below: 
http://www.drugwatch.com/use-of-surgical-mesh-expected-to-grow.php#.T4ZMfZ2Xgyw.twitter

This is a very informative article from The Trial Lawyer magazine regarding the ongoing litigation over surgical mesh implants.  Check it out! 

Congress will soon vote on the SOUND Act which would enable the FDA to require manufacturers of devices based on older devices that have safety issues to provide proof that the new product’s design has fixed potential problems.  This legislation would strengthen the FDA’s 510(k) process which regulates the marketing of medical devices.  Sponsors of this bill and even members of the FDA believe some sort of revision is necessary because right now the FDA clears an average of 28 devices per year based on previous devices that have been recalled.  Check out the article below for more information:

http://www.boston.com/Boston/dailydose/2012/03/markey-targets-boston-scientific-and-other-vaginal-mesh-manufacturers-new-bill/cbRwrxfilIeMbu9Ll5Nc7M/index.html

Now that lawsuits against surgical mesh companies, regarding the safety and effectiveness of the device for pelvic organ prolapse, stress urinary incontinence and hernia surgery, are increasing, Johnson and Johnson, one of the leading manufacturers, is in the spotlight.  According to the FDA, J&J was illegally marketing the unapproved vaginal mesh implants starting in early 2005; the FDA did not approve the device until May 15, 2008.  Since then, the FDA has mandated that J&J and other manufacturers study the organ damage and complications related to these products, since most of them were approved per the FDA’s fallible 510(k) approval process.  We recommend you read the entire article below:

http://www.bloomberg.com/news/print/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html

The Wall Street Journal published an article yesterday warning patients of the risks of hernia repair surgeries. The article presents the pros and cons of two main surgical options and a description of the procedures, including the use of synthetic and biologic mesh. Researchers also warn that smoking and obesity can increase risk of hernias and post-operative chronic pain. See the article below for more information: http://online.wsj.com/article/SB10001424052970203833004577249344022834000.html

The subcommittee on Health will hold a hearing on Wednesday, February 15, 2012, at 10:00 am ET, entitled "Reauthorization of MDUFA: What it Means for Jobs, Innovation and Patients."  This hearing could mean more regulation when it comes to the FDA approving all classes of medical devices, and thus a higher level of patient safety, surgical mesh devices included.  Class III devices need the highest level of oversight and are also cleared by another process called a premarket approval application.  Both processes will be reviewed at the hearing on Wednesday.

To watch the hearing live, please click here when the hearing begins:

http://www.energycommerce.house.gov

For more details on the background of the current FDA processes and to see the names of the expert witnesses who will be in attendance, check out the link below:

http://meshmedicaldevicenewsdesk.com/featured-articles/call-to-action-hearings-on-mesh-medical-device-budget-pits-patient-safety-v-industry-must-watch-live-feed/

Earlier this week, the U.S. Judicial Panel on Multidistrict Litigation established new MDL cases against three surgical mesh manufacturers; American Medical Systems, Inc., Boston Scientific Corp., and Ethicon, Inc./Johnson & Johnson. Check out the article below for the details: