Guest post: Surgical Mesh and the FDA

 

Although surgical mesh has been in use for decades, it was not until 2002 that the Food and Drug Administration (FDA) approved the use of transvaginal mesh for treatment of pelvic organ prolapse.

Since that time, the FDA has received numerous reports of complications associated with transvaginal mesh. On July 13, 2011, the FDA released a statement that informed consumers that the complications associated with transvaginal mesh are not rare and that traditional surgery methods for the treatment of urinary incontinence and pelvic organ prolapse may be more effective and carry less risk.

For those who have already had transvaginal mesh implanted, or for those considering this treatment, this release from the FDA is cause for real concern. There are, unfortunately, numerous complications and many of these complications are quite severe.

To date, the most common complaints associated with transvaginal mesh include:

1. Protrusion or erosion of the mesh. This complication is very serious. Protrusion means that the mesh works its way through nearby organs.

2. Organ perforation. The surgical procedure or the transvaginal mesh itself can perforate — or puncture — nearby organs.

3. Additional complications. The FDA has received numerous reports of neuromuscular issues as well as psychological trauma following the insertion of transvaginal mesh. Some patients have reported feeling the mesh inside their body; sexual partners may also be able to feel it.

The way the mesh is inserted may actually determine the extent of complications a patient will face. The FDA has stated that proper training can reduce the likelihood of these complications. The FDA reports that mesh inserted transvaginally rather than through an abdominal incision results in a higher risk for complications. Even though there have been serious risk associated with this surgical mesh, the FDA has yet to have a Vaginal mesh recall.

For patients, this news from the FDA is understandably disturbing, particularly if their doctors had not previously informed them of the potential risks they would be facing. If your doctor has recommended this procedure to treat pelvic organ prolapse or urinary incontinence, it is vital to make sure you are fully aware of the risks you are facing. Ask your doctor if they have received the recommended specialized training.

It is also important to get a second opinion, in light of the very real health risks you could be facing as a result of this procedure. The FDA has stated that traditional surgery to repair pelvic organ prolapse or urinary incontinence may actually be more successful than the use of transvaginal mesh and carries much less risk for the patient.

So far, nearly 4,000 complaints have been received regarding the use of transvaginal mesh in these treatments. The FDA continues to monitor the situation, and encourages more education both for surgeons and patients. Even though pelvic organ prolapse is a painful condition, patients need to be aware that they may be facing more pain and more surgery if they elect to go with transvaginal mesh. Transvaginal mesh lawsuits have already been filed due to these severe complications.

Elizabeth Carrollton writes about defective medical devices and dangerous drugs for Drugwatch.com.

 

On guard!

Human beings make mistakes.  If we didn’t, there would never be a need for any kind of safety device – from a seat belt in a car, to blade brake on a saw, to a guard on a piece of industrial machinery.  Engineers and product designers know this fundamental truth and are supposed to take it into account when designing things.  If they don’t, that’s on them.

That would ruin your day.

It hasn’t been released yet what happened this month to the woman in Barberton, Ohio who’s hair became snared in a machine that cuts off metal pipe.  Amazingly, she survived, but only after her scalp was ripped from her head.  Was the machine properly guarded?  Did it use electronic eyes (like on your garage door) that detect a person moving or hinge-actuated interlock switches  – either of which can automatically shut off the machine’s moving parts.  That way, if the machine fails, it fails to a safe state, i.e., it fails safe by design.  Or, were there guards on the machine that, at some point, were taken off?

What does this mean to you:

While manufacturers of dangerous products can be responsible for injuries caused by those products, generally your employer is not.  However, if the employer removes a safety guard, that employer may still be responsible for injuries caused on the job.

Not a leisurely stroll

Longtime readers of FSBD know I’ve covered the issue of dangerous children’s products before on this blog.  I saw this article today that Peg Perego stollers have just been recalled, with at least one death reported.  This, in the wake of other recent stroller recalls by both Graco and Maclaren.

Weeeeeeeeeeeeeeeeeeeeeeeee!

What this means to you:

Though we may not want to do it for every DVD player or blender we buy, take 30 seconds and fill out the warranty card so you are apprised of recalls as soon as they happen, especially for products that impact the safety of children.

Now I know more

Everybody’s heard about the lawsuit that seems to crazy to be true – whether it the McDonald’s coffee case or some other.  You may have seen emails being forwarded around highlighting some cases, claiming to be real life examples of our legal system out of control.

Psst! I know more than you do.

Now there is a website devoted to focusing a spotlight on the other end of the spectrum – corporate misdeeds in the name of profit and at the expense of people and their lives.  Check out the Now I Know More site at nowiknowmore.com.

What does it mean to you:

Don’t accept what you read about our legal system at first blush.  Lots of powerful and well-funded special interests devote a lot of resources to convincing the American public that our civil justice system is broken. Consider the source and what they have to gain by spreading such misinformation.

Four score and seven fingers ago…

Now is the time you would expect a blog about product safety to post various tips and links about current fireworks law in Ohio and about how dangerous fireworks are, how you can be pretty badly hurt by them, and how you should really never use them.  Ever.  Well, not this blog.

Pew, pew, pew!

Instead, remember (just as I remind my kids each year when I read the Declaration of Independence to them) that one of the reasons we actually broke off and started are own, brand new country was the fact that King George III had taken away our right to have a jury trial.  That’s right.  Having your case heard before a jury – where both parties stand equal before the law- was so important to guys like Jefferson and Madison, that if they couldn’t have it, they were going to start their own country.  Jefferson even listed in the Declaration of Independence that the King was “depriving us in many cases, of the benefit of Trial by Jury.”  That, among other reasons, required our separation from Britain.

What does this mean to you:

Be well, and have a safe and happy Fourth of July.