The cure may be worse than the symptoms

Thousands of women across Columbus, Ohio, and the country have had vaginal mesh, or bladder sling, surgically implanted in an attempt to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

tired woman

Unfortunately, mesh can erode and fail, causing bleeding, pain during intercourse, vaginal scarring, and urinary tract infection, among other symptoms.  The FDA not admits that mesh failures are “not rare.”

Mesh implants were mainly manufactured by four companies – American Medical Systems, Boston Scientific Corp., Johnson & Johnson’s Ethicon and C.R. Bard.

What does this mean to you:

Sometimes, a product which is meant to help, only hurts, and makes things worse.    If we can help or answer any questions, please do not hesitate to contact us.

 

 

And now we wait

A jury in New Jersey has begun deliberating on one of the first trials involving surgical or transvaginal mesh.

waiting

The outcome of this early “bell weather” trial will impact how the mesh manufacturers approach the thousands of remaining cases where women suffered bleeding, infection, pain, and urinary problems from the mesh implants.

 

What does this mean to you:

Though it may seem distant and unrelated, early trials in cases like this can have massive legal ripple effects for the remaining individual claims.

 

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.

 

Thanks for nothing

Medical devices are supposed to solve our medical ailments, not cause them.  What am I missing here?

However, the FDA announced last summer that it was concerned about problems caused by surgical mesh – a medical device implanted, usually in women, to repair a hernia or pelvic organ prolapse (POP). Problems can involve bleeding, infection, pain, and urinary problems.  Then, earlier this year, the FDA ordered makers of surgical mesh to more closely study the risks involved with their products.  As of today, Johnson & Johnson, one of several manufacturers, has stated it will no longer sell surgical mesh products.  (Recall that this is the same Johnson & Johnson who also made the now-recalled DePuy ASR hip implants.)

What does this mean to you:

Though surgical mesh has not been recalled, it has caused enough issues to raise serious concerns.  Keep in mind that complications following a surgery are not always “normal,” and may actually be related to a medical device with known problems.