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Thursday, May 29, 2014

Surgical mesh and medical destitution: a medical device failure.



1
26 May 2014
by Brittany Nunn


Photo by Hal Samples
Lakewood neighbor Aaron Horton just wants her mom back.
It’s the little things — like going out for sushi, window-shopping, getting facials or manicures, and chatting about art — that Horton misses the most.
“I miss my mom,” Horton says. “I miss being able to pick up the phone and say, ‘Hey, I just saw this purse and it made me think about you,’ or ‘I just saw this movie; let me tell you about it.’ ”
Although Horton’s mom is still alive, in many ways Horton has been forced to prematurely grieve the loss of the mother she once had.
Horton’s mom, who asked that we not reveal her identity, is in a constant state of excruciating pain — at times worse than anything she experienced during childbirth — due to an injury caused by a medical device called trans-vaginal mesh.
The pain wasn’t always so extreme.
Originally, Horton’s mother suffered from urinary incontinence (the loss of bladder control) and pelvic organ prolapse (a condition in which the bladder and the bowels slip out through the vaginal canal). To fix the problem, doctors used trans-vaginal mesh, which essentially is a small hammock made of plastic mesh, to hold her organs in place.
She was told the operation would be minimally invasive, but she knew something was wrong as soon as she woke up from the surgery. Her surgeon told her she simply needed time to heal.
The pain was localized at first, occurring only in her pelvic region, but it was unrelenting. For months, doctors dismissed the pain. Eventually it began to spread to every part of her body — sometimes it was sharp, sometimes it was dull, sometimes it was throbbing, and sometimes it was all three. She talked with more doctors, but no one could give her any answers. She tried physical therapy and nerve blocks, but nothing helped.
“My mom was really sick, and she wasn’t getting better,” Horton says.
“Once I realized how sick she was, I got online to see if there were other people, and I realized there’s this whole community of women who have been injured by this medical device.”
Horton wrote what she calls “a hearticle” about her experience of watching her mom suffer and not being able to help, and it was published on journalist Jane Akre’s website, Mesh Medical Device News Desk, in July 2013. Horton received an outpouring of support in the comments section.
“They had all gone through the same thing and had the same questions,” she explains. “I thought I was going to get some help, and then it just kind of confirmed that there was no help available.”
It spurred Horton to dig deeper, to find some answers for her mom, as well as for the many other suffering women.
She discovered that doctors have used medical mesh in more than 1.5 million women to fix organ prolapse, urinary incontinence or hernia, and they continue to implant it in some 70,000 to 90,000 women every year.
Most of the women are post-menopausal baby boomers who have had children.
Although many women are happy with the implant, thousands report suffering due to injury caused by the device.
Horton formed a nonprofit called The Mesh Warrior Foundation For the Injured, which she operates from her Lakewood home. She works full-time doing research, talking with doctors and surgeons, raising awareness about the mesh-related injuries, and advocating for the injured.
What Horton found during her research shocked her.
There are six manufacturers of the product, and the largest one is Johnson & Johnson, through the medical unit of its company, Ethicon.
Medical mesh is made of propylene plastic, and it was originally used for hernia repair. Then, in early 2000, manufacturers began creating other mesh products, which Horton says were never tested on live humans, only cadavers and dogs.
The U.S. Food and Drug Administration (FDA) approves the products through the 510(k) process, which “clears the device for commercial distribution” without having to go through the entire process, according to the FDA website.
Instead, manufacturers simply have to prove the new product is “at least as safe and effective” as a predicate device of substantial equivalence (SE) that has already been approved by the FDA.
As soon as the FDA rubber-stamps the device, manufacturers are free to start marketing it. Although there are other ways to fix medical issues such as incontinence or pelvic organ prolapse, most of the alternative methods are considered invasive, complicated and expensive. Mesh was marketed as simple and cheap, and the general public became the test subjects, Horton says.
The FDA in 2008 issued a Public Health Notification regarding “serious complications associated with trans-vaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.
The notice states, “The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.”
“My question was: How did this happen to 1.5 million women?” Horton asks. “All the safeguards we have in our society, and we’re supposed to have the best health care in the world and the best access to it.”
Dr. Michael Hibner, the director of the division of surgery and pelvic pain at St. Joseph’s Hospital and Medical Center in Phoenix, has been removing the mesh from women’s bodies for several years.
“I think it’s a very small percentage [of women] that have a serious reaction,” he says. “There are people who are happy with the mesh. The problem is that those who are unhappy with it are really, really unhappy with it.”
Most of the women Hibner sees have pain due to three things: pain from the mesh rubbing against or tugging at the nerves, nerve damage during implant or explant of the mesh and/or a foreign-body reaction to the mesh itself.
Hibner believes manufacturers are largely to blame for the mesh-related injuries.
Hibner says that if the procedure is done right, women shouldn’t have pain or discomfort. The problem, Hibner says, is that manufacturers are selling the device to doctors as a one-size-fits-all device, and it’s being touted as a simple, non-invasive procedure, so the doctors implanting the mesh haven’t been appropriately prepared or trained.
Dr. Greg Vigna, who spent 18 years in the medial industry but now practices law in catastrophic injury in California, is familiar with the trail of broken lives mesh-related injuries leaves behind.
As a doctor, Vigna worked with patients who suffered from pudendal neuralgia, which is chronic pain due to the pudendal nerve, which is located in the pelvis, being entrapped or compressed. Until a few years ago, this was very uncommon.
“This mesh device caused a problem that used to be very rare,” he says. “It’s not rare anymore because mesh has been used so many times.”
Most women do not have the time, resources or the physical wellness needed to go head-to-head with pharmaceutical companies, so they become “medically destitute,” Vigna says. They lose their jobs because they can’t work, they lose their husbands because they can’t have sex, and they lose their families because they’re in so much pain they can’t function normally.
“There’s failure in the medical community, there’s failure in the financial community, and there’s failure in the legal community,” Vigna insists.
At the time of publication there had been 56,999 mesh-related lawsuits filed, according to Vigna, but very few settlements have come down.
At the same time doctors like Hibner are taking the mesh out, hundreds more continue to put it in. Other doctors try to remove mesh, but very few know how to do it correctly, Vigna says.
“For years women were only getting part of the mesh taken out, and that wasn’t helping,” Vigna says. “In fact, that was just making things more complicated for future doctors.”
Most of the women Hibner sees have already had the device extracted but are still experiencing pain, usually because parts of the mesh are still inside the body, pulling at sensitive nerves. He says he believes removing the entire device, all at once, is best.
“I’ve seen women who have clearly gotten better after removing the mesh. But then, there are other ones who didn’t. So I think it depends on the patient. Some have had more injury to the nerves, and others have had less injury to the nerves, so it’s hard to tell.”
Horton and her family are crossing their fingers, hoping Horton’s mother is one of the lucky ones.
Horton’s mother had surgery to have her mesh removed in May, and her family is still waiting to find out if the surgery was successful in lessening or erasing her pain.
“But the truth is, each injury is different,” Horton says. “They don’t know what happens during the explant because it just depends on the woman’s body and the kind of injury.”
In the meantime, Horton continues to research and fill her blog with personal stories and interviews with doctors in hopes of reaching as many women as possible.
“There’s still so many more who don’t know,” Horton says. “That’s what keeps me awake at night.”
To learn more  about Aaron Horton and The Mesh Warrior, visit themeshwarrior.com

- See more at: http://lakewood.advocatemag.com/2014/05/26/medical-mesh-tangled-web/#sthash.m0XaEEZh.dpuf


Comment - FiDA  (retrieve this)
Thank you for this excellent article, Brittany Nunn and Lakewood/East Dallas Advocate!  My advocacy to demand safer and more effective implanted medical devices began 5 years ago when a family member began suffering with a failed implanted device.  What I learned chills me to the bone in the middle of a Dallas summer:  the system is rigged!  Medical device companies have so much clout that our FDA is a mere mirage and there is no "there" there.  Patients are not protected and even the judicial system has been altered to favor the industry and protect the profiteers from accountability.  The mounting patient harm signals "settlements" that do little to stop the carnage.  I blog at Failed Implant Device Alliance and attended FDA Patient Representative training (by invitation).

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