Wilmington Personal Injury Lawyer - Medical Devices & Implants

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 Pain Pumps Recalled

Jean Martin — Mon, 29 Sep 2008 13:20:09 GMT

The FDA has issued a recall for Medtronic drug pumps. The recall notice came Friday. The pumps involved are the Indura 1P Intrathecal Catheter, model 8709SC; Intrathecal Catheter, model 8731SC; Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. The pumps are used in patients who have spasticity related to cystic fibrosis, traumatic brain injury and multiple sclerosis and from chronic pain.

The FDA issued a Class I recall which means that there is a "reasonable probability" that the product may cause serious adverse health consequences or death. Improper connections between the implanted catheter and the pump cause the medications to leak. At least 25,000 of these pumps have been sold.

Originally posted at InjuryBoard by Jean Martin

Can You Hear Me Now? Yes, We Heard Your Hip Squeak.

Jean Martin — Mon, 12 May 2008 12:47:02 GMT

Another report appears in the New York Times today relaying stories of hip implant patients whose implants are causing embarrassing problems because they squeak. Hundreds of people who have undergone hip replacement surgery using ceramic implants are experiencing the same problem - their hips squeak. We are not talking just a low level noise. The implants are squeaking loud enough for others to hear, and hear well. Reports are that the noise is so loud, that the first time patients hear themselves, they think there is an animal around or something else creating the ruckus.

Squeaking was a pretty rare report under Stryker began manufacturing and selling ceramic hip implants in 2003. No one is saying why they implants are squeaking, and unfortunately, many doctors are telling their patients that they will just have to live with it. Why should manufacturers be allowed to sell a product that will cause consumers a life of embarrassment, especially when other models of implants are available and are not causing these problems? And is the squeaking just a sign of things to come? Many fear that the squeaking can be a sign of the components of the implant rubbing against each other and that the components will eventually wear out prematurally. Durability is a key factor in hip replacement surgery. The surgery and recovery is so grueling that patients want to be assured that their implants will last as long as possible. They may not have this assurance with the Stryker hip implants.

Thank you for visiting InjuryBoard.

Originally posted at InjuryBoard by Jean Martin

My Bones Ache And Pop, But Is My Hip Implant Supposed To Squeak?

Jean Martin — Fri, 25 Apr 2008 17:31:00 GMT

Hip implant surgery sounds like a terribly, painful process, but I have been told that the relief of chronic pain makes the surgery worthwhile. But now many hip implant folks are noticing that their joints are squeaking. Sometimes doctors tell them that this is something that they must endure. But now we know that the squeaking is the result of a defective implant.

The first sign of trouble for Stryker hip implants surfaced in 2005 with news of multiple consumer complaints. These complaints consisted of a myriad of problems, including squeaky joins, extreme pain and discomfort and improper fittings of the implants that led to bone fractures in patients. Patients have also complained of difficulty walking due to the pieces of the implant breaking off or wearing down unevenly. Some of the implants were defective to the point that the patients had to undergo additional surgery to repair and replace the implants.

Fast forward three years later to January of this year when Stryker announced a recall of two products in the company's Trident line. Interestingly enough, the problems leading to the recall related to manufacturing issues different from the ones first discovered in 2005.

Over the last three years, Stryker has been repeatedly warned by the FDA to fix these defective orthopedic implants. Despite numerous complaints, the company just hasn’t seemed to want to address the problems.

Several lawsuits have been filed alleging complications due to the defective Stryker Hip Implants. But most notable is the seemingly low number of suits filed. Are there patients out there who believe that the pain they are experiencing or the squeaking that they are noticing is in the ordinary course of business? Are patients afraid that if they speak up, their doctors will advise them to undergo another gruesome surgery?

Whatever the reason, if you have had a hip implant and are experiencing any of the following problems, you need to consult your doctor immediately:

Bone fractures and broken bones
Component breakage and chipping
Uneven component wear
Squeaky or noisy hip implants
Pain and discomfort
Difficulty walking

Originally posted at InjuryBoard by Jean Martin