Wilmington Personal Injury Lawyer - medical device

More Evidence That Consumers Are Not Protected By FDA - Congressmen Influence FDA Device Approval

Jean Martin — Fri, 25 Sep 2009 10:03:28 GMT

The FDA released a report yesterday stating that the agency and its former commissioner, Dr. Andew C. von Eschenbach, succumbed to pressure by four New Jersey congressmen in approving a collagen implant patch for injured knees last year. That approval is now being re-visited and re-analyzed.

Apparently FDA scientific reviewers had declined approval for the Menaflex device manufactured by ReGen Biologics, Inc. for years citing its high failure rate. The decisions against approval had been unanimous - that is until four New Jersey congressmen - Senators Robert Menendez and Frank Lautenberg and Representatives Frank Pallone Jr and Steve Rothman - stepped in to assert their influence on behalf of the New Jersey-based manufacturer. Not surprising, all four legislators received significant campaign contributions from ReGen.

It is sad and scary to think that manufacturers can literally buy approval of their product and an agency as important as the FDA can give it to pressure by politicians and ignore their own scientists. This is yet another example of the FDA failing the American public. We think that if a pharmaceutical drug or medical device has FDA approval, then the product and drug has passed all types of stringent safety testing. It just isn't so. And the manufacturers want to hide behind this veil of "FDA approval" and take your right to seek compensation from them should you be the unfortunate one injured by their product? The public simply shouldn't stand for it.

Call your Congressman today and tell them to listen to you and not the manufacturers. Tell them to support the passage of the Medical Device Safety Act to protect the public from defective devices and hold manufacturers accountable.

Originally posted at InjuryBoard by Jean Martin

WECT Leaves Out Important Information Regarding Use of Mesh Sling for Female Urinary Incontinence

Jean Martin — Thu, 25 Jun 2009 10:56:36 GMT

On July 24, 2009, WECT in Wilmington, NC ran a Lifewatch story on urinary incontinence in women and the use of a midurethral mesh sling to solve this problem suffered by so many women. While somewhat informative, WECT left out important information regarding the problems that have occurred since this product entered the market. I am really disappointed that the piece by WECT did not mention at all any of the problems experienced by women who have had the mesh sling implanted, especially given the warnings and action by the FDA with regard to these products.

In October 2008, the FDA issued a public health warning advising consumers and doctors about the serious complications association with the use of this surgical mesh to treat Stress Urinary Incontinence and Pelvic Organ Prolapse. In many cases, women who have had these slings implanted, have required multiple surgeries and have been left with permanent and debilitating injuries. Problems that can arise include vaginal or pelvic pain, bloody discharg, foul vaginal odor, vaginal infections and severe pain in the back, hips and legs.

InjuryBoard has been a series of articles chronicling the horror stories of these women and I would invite any woman considering this option to look at this before making any decision. Some of these mesh products have been removed from the market. A group called Truth in Medicine has formed to advocate for the removal from the market of all synthetic mesh used to treat urinary incontinence in women.

Women need to discuss with their healthcare providers the complications that may arise with the use of the vaginal or midurethral mesh sling. Know all of the facts before you make a decision that could change your life.

Originally posted at InjuryBoard by Jean Martin

Medtronic Infuse Bone Graft - Patients Beware

Jean Martin — Sat, 25 Apr 2009 05:49:00 GMT

The Medtronic Infuse Bone Graft system is a cage type system implanted into the spine which containes a protein that is capable of initiating bone growth. The Medtronic Infuse Bone Graft has FDA approval to be used in the lumbar spine - or lower back. However, it has come to light that Medtronic pushed doctors to use the Infuse Bone Graft for the cervical spine - the neck - as well, without FDA approval. This non-approved use in the cervical spine has led to numerous complications including swelling of the face and neck and trouble breathing due to restriction of the airway. Others report difficulty swallowing and speaking. Unfortunately, even though the Infuse Bone Graft is not approved for use in the cervical spine, doctors receiving financial incentives from Medtronic have continued using them for cervical spine surgeries, including cervical spine fusions.

The Wall Street Journal has reported that Medtronic is being investigated becaue of the allegations that the company gave doctors numerous incentives to use the Infuse Bone Graft. Medtronic has paid out over $40 million to settle whistleblower lawsuits by former employees who alleged that Medtronic paid doctors to use the Infuse Bone Graft off-label and other spine products manufactured by Medtronic.

When implanted into the neck, the protein used by the Infuse Bone Graft can cause bone to form in teh neck, causing breathing and swallowing to be difficult, and can cause death. Doctors should stop this off-label use of the Infuse Bone Graft system and Medtronic should be held responsible for the harm it has created.

Originally posted at InjuryBoard by Jean Martin