Personal Injury Law

Suffering In Silence From A Medical Device - Surgical Mesh (Part 1)

By Jane Akre

Suzanne McClain

Suffering in Silence (Part 1) 

It's not an uncommon problem.

13 million American women experience stress urinary incontinence (SUI), a leaking of urine during moments of physical stress that can include coughing or laughter.  

When 43-year-old Suzanne McClain of Maben, Mississippi went to her doctor with the problem in 2004, he assured her he had an easy fix.    

She tells IB News that he recommended outpatient surgery to support weakened muscles and support the bladder. He would implant a sling, a synthetic mesh material roughly the size and shape of a ribbon, placed under the urethra and the bladder.  It's the procedure of choice for many doctors. 

"He told me it was the most wonderful thing invented," McClain says, "and that I'd never have this problem again."

"He said how it was minimally invasive taking less than an hour to implant, how I could return to work in a few days, how I may have minor discomfort or even minor bleeding, but that was normal."

It is a better option to wearing a diaper-like product for the rest of your life.

Women of all ages can have weakened pelvic muscles that fail to support the urethra and bladder in the correct position. Pregnancy childbirth, obesity, age, menopause, or heavy lifting can cause SUI.  Mesh slings are also used to treat women with weak muscles that fail to support the pelvic organs known as pelvic organ prolapse (POP).

It's now estimated that about one-third of women over the age of 65 have some degree of incontinence.

McClain says her doctor told her he would use the TVT mesh, one of three types of slings commonly used in the U.S.  

She later learned that TVT stood for Transvaginal Tension-Free (TVT) mesh, made by Ethicon, a division of Johnson & Johnson.  A polypropylene woven net-like device with metal wire throughout that resembles a loofah used in the shower to exfoliate the body. 

Familiar with internet research, McClain says she found nothing that would lead her to believe that the Ethicon TVT mesh had any problems. An internet search took her back to Johnson & Johnson's Website and the positive reviews and a one in a million chance of complications.

Complications

And McClain had no problem for four years, until one day she knew something was wrong.   

"It was 24-7, and there was a God awful odor that would not go away. I tried Monistat and antibiotics. I realized I had a problem."

"You've won the prize and it's not a good one," she says her urologist told her, insisting he had never seen this result beyond six weeks after surgery.

"I was put out by that," she says. He gave her estrogen cream to deal with the problem.    She never went back to him.

In July 2008, her new doctor, a urogynecologist, confirmed she did have a problem. The mesh had eroded through her vaginal wall. One month later she had surgery to extract about one-third of the mesh medical device.

The surgeon said he tried to extract the rest but it had become enmeshed in her tissues so he would leave the remainder behind. If the mesh continued to migrate it would have to be extracted through the abdomen, dissecting her tissues from within the mesh.

It's a complicated surgery and can be dangerous.   Suzanne says she and her husband realized she could die.

"I was never told about the risks, I was told nothing but that there would be minor pain and bleeding for a few days, then you can go back to work. I was never told about the erosion or adherence to organs. Had I known that, I would have weighed my options."

And McClain says she was not told about the biologic mesh option, created from the patient's own body.  Before the evolution of synthetic mesh, surgeons would use a band of tissue from a patient's abdomen, or from a cadaver, and form it into a sling, crafted to fit an individuals' anatomy.

The downside is the cost - about ten times higher than synthetic mesh. Hospitals decide which mesh to use based on cost efficiency.  And for practitioners, it takes a higher degree of skill to harvest the biologic sling material and craft it appropriately choosing the right needle and thread to keep it in place.

The majority of synthetic slings today, like the Ethicon, are pre-cut and delivered in a box to surgeons who are trained in their use by the manufacturers, that claim an 80 to 95 percent cure rate for urinary incontinence.

Today her condition has stabilized but she still suffers from SUI.

"It greatly concerns me that I will not know if or when this migration begins to take place, and that other erosions may occur, or that the remaining pieces may in fact adhere to organs or nerve beds, creating even more complications for me."

Not Suffering in Silence

Again searching the internet, she realized this problem was bigger than her own. 

McClain found hundreds of women suffering in silence, too embarrassed to speak about pelvic pain; a court system that doesn't recognize medical device injuries; and a critically ill Center for Devices and Radiological Health, which oversees medical devices under the Food and Drug Administration (FDA) that approved mesh for sale while only assuming safety.   

Instead of suffering in silence, Suzanne has joined the patient advocacy group -Truth in Medicine - in demanding a Congressional hearing to have synthetic surgical mesh removed from the market. (Continued in Part 2) #

Full post as published by InjuryBoard on March 30, 2009 (boomark / email).