MARCH 19, 2012 ~ By Jane Akre A story before I tell this story. I was commissioned to write a 2,100 word piece for the Chicago-based magazine “In These Times.” I had pitched the long-time editor and he said they were very interested. Great I thought. The money wasn’t much but the exposure for an important issue is priceless. Besides, how the media works is when one outlet does a story they play follow the leader and others pick it up. So I did the nifty story, submitted it on time. This pm the editor said he noticed two lawyers are linked to the site so they can’t pickup the story, it’s a conflict of interest.
I understand and often feel the same way. The public doesn’t think journalists have standards but there are very strict standards for the best journos and I believe he is very good. But I insisted, I’ve flown myself to the FDA hearings, I’ve been following the issue since 2009 and am truly interested in the topic and feel it’s an important story of our time. I’m not soliciting for the attorneys, they just offer some support! Do I have to take a vow of poverty to be a journalist? The New York Times takes ads for BMW, does that mean there is a conflict? I was getting a bit flustered and I’m afraid it showed.
It fell on deaf ears – any association with lawyers is a conflict. Some other journalist will have to do the story. Maybe they could interview you, he said. Right.
Sometimes you can’t catch a break. Anyway here is the story I did. Too bad they won’t read it in In These Times.
The email came in on February 21, 2012. It said “Please Help Me”
Okay I thought, this is a scam. Someone crying that their funds are tied up in a Ugandan trust and they need me to forward cash. Right.
But lately I’ve heard from too many people who are desperate for answers because they are in severe pain following a common medical procedure – the implantation of synthetic surgical mesh to treat hernias in men and women and pelvic organ prolapse and incontinence in women. So I clicked.
“Jane, I am sitting in a hotel room here in Washington DC. Flew in from far west Texas to see a doctor to consult about mesh removal for my mom. This doctor was highly recommended. My mom is in such pain and has been for two years…the flight alone was hell. She was a very active woman prior to having this put in her.
This was a waste of time and money as the doctor here acted like this was no big deal and referred us to some urogynecologist in Albuquerque.
Jane, I don’t know what to do. I have never seen my mom cry like this. I have never seen her so weak and scared. No one in my web research will say with clarity who to trust. I am flying back home tomorrow with my mom and I am more confused than ever. My mom is saying things like “I just give up.”
What do I do? PLEASE PLEASE give me any guidance you can.”
The woman left her phone number and email. Her mother turned up in a cursory Google search to be who she claimed. I called the daughter.
There are thousands of men and women living in debilitating pain from permanently implanted synthetic petroleum-based surgical mesh. Turning to me as an option shows just how desperate these people are. I’m not a doctor or a lawyer but a journalist who began writing about mesh complications in the spring of 2009 after being contacted by a persistent mesh victim.
I couldn’t believe what I heard. For some reason, in some people, mesh migrates and perforates organs, erodes into the vagina, can cause a systemic inflammatory response and intense pain all over the body. In men, hernia mesh has been known to entangle nerves and form a hard plastic ball. The actual complication rate is unknown even by the U.S. Food and Drug Administration (FDA).
The thousands of mesh-injured men and women are victims of a perfect storm – the aggressive marketing of the medical device industry paired with the hands-off regulation by the FDA toward medical devices which relies on the mesh makers for assurances of safety and efficacy.
And while I tell the stories of women and men who are injured by surgical mesh on my Mesh Medical Device News Desk (MDND) website, there is very little I can do to help. I don’t refer the injured to lawyers or doctors, despite receiving support from two law firms, but what I do, as I did here, is put her in touch with women and men who have gone through the same living hell and are now advocating for others.
Many who I talk to are bankrupt and without insurance. Others return to their original doctor only to be turned away with phrases like, “You’re the only one I’ve seen,” and to be given a prescription for an antidepressant.
Others begin a succession of specialist visits only to be met by a wall of resistance and denial. In some cases, a doctor will attempt a removal only to leave the arm of the mesh behind which often leaves the woman in worse condition.
“On return to the doctor who placed the mesh in me, he claimed upon re-examination that he could not find anything wrong. I suffer with excruciating pelvic pain on my left side radiating into my lower back spine left side. I’ve had CT scans, a MRI and can’t seem to diagnose anything. I can’t stand or sit for long periods or walk. NO one can help me. I’ve been to three different OB-GyNs with the same thing, we can’t find anything.”
A man told me his mother was in such pain from a mesh implant that she shot herself to end the pain.
HOW DID WE GET HERE
An estimated 13 million American women experience stress urinary incontinence (SUI), a leak of urine that can happen during a sneeze, laughter or physical stress. It’s estimated about 20-40% of women have some form of incontinence.
Pelvic organ prolapse (POP), involves the decent of pelvic organs, the bladder, urethra, small bowel, rectum, or uterus, through the vaginal vault due to weakness of the connective tissues due to multiple births, age, hysterectomy, menopause and injury. Some experts feel we inherit the collagen which makes connective tissues and muscles strong. Exercise, or the lack of, may play a role.
Except in rare cases, POP is a nuisance but not life-threatening and many women are asymptomatic. The condition can be maintained by using a pessary, a rubber insert that holds back descending organs, making lifestyle changes, and through surgical intervention to stitch up the anterior or posterior vaginal wall.
Surgical mesh was first used to repair abdominal hernias in the 1950s, but fast forward to the 1990s and fuelled with aggressive marketing pushing a host of new petroleum-based materials, gynecologists began using synthetic polypropylene or polyester surgical mesh, some delivered in precut boxes, to hold up the urethra or the vaginal vault.
The FDA reports about 300,000 U.S. women underwent POP repair in 2010 with 75,000 of those procedures involving transvaginal (through the vagina) implantation of surgical mesh. And even gynecologists, many who were never trained as surgeons, can attend weekend cadaver training sessions offered by the major mesh makers – Ethicon (Johnson & Johnson), Boston Scientific, American Medical Systems, and C.R. Bard to learn how to implant mesh in the blind procedure.
One woman told MDND her doctor said this new surgical option for his practice would be his “bread and butter.”
“Biggest regret of my life, as it has ruined my life, my sons childhood, and my hysbands and mines marriage. Its truly a living hell. ~ 25-year-old implanted with mesh after a hysterectomy.
Most Americans assume that medical devices undergo the same sort of scrutiny as pharmaceuticals, but they would be wrong. Ninety percent of the 4,000 medical devices approved for market by the FDA every year do not require proof that they have been clinically tested for safety and efficacy.
Instead, they are approved under the 510(k) process –a fast-track system that’s an approval for marketing. Device makers like the relative low cost and ease that can bring their device into the marketplace after an exchange of paperwork.
Most of today’s gynecologic mesh can thank Boston Scientific. In 1996, the FDA cleared its ProteGen Sling for market which served as the ‘predicate,’ a device “substantially equivalent” to the new one seeking approval, required under the 510(k) process.
From 1992 to 2010, the FDA cleared 168 510(k) for synthetic surgical mesh for urogynecologic conditions, many which named the ProteGen as predicate. But there was a problem.
ProteGen was recalled in March 1999 for being defective, “adulterated and misbranded.” But there is no trigger within the FDA to initiate a re-review of all of the devices that had named the defective ProteGen as a predicate.
The FDA reports in 2001 the number of clearances per year doubled and increased another 50 percent the following year.
And so did the complications.
By 2011, the agency reported 2,874 reports of injury, death and malfunctions from January 2008 to December 2010 associated with urogynecologic surgical mesh – a fivefold jump. Falling just short of a recall, a Public Health Notification by the FDA in July 2011 warned of the risks of mesh.
“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
DOCTORS ON BOARD
Daniel S. Elliott, MD, Assist Professor of Urology at the Mayo College of Medicine in Rochester, MN specializes in female urology and pelvic organ prolapse. He told MDND that the Mayo Clinic refuses to use mesh for transvaginal POP repair because it carries more risks than added benefits.
“On a weekly basis, either I or my colleagues evaluate and treat patients suffering from the consequences of the non-absorbable mesh kits. The diagnoses run the gamut of mild vaginal erosion (or extrusion) to devastating urethral and/or bladder erosions with severe, debilitating, life-altering chronic pelvic pain. The patients have suffered needlessly because the standard POP repair without mesh, in properly trained hands, is easy, fast, and effective, avoiding the unique complications associated with non-absorbable mesh kits.”
Dr Elliott has joined Public Citizen in calling for a complete ban on synthetic mesh until multiple independent, non-industry supported research can show any benefit.
“Anything less would be surgically irresponsible and ethically unacceptable.”
SUFFERING IN SILENCE
One woman, who does not want to be identified, had a professional life including a waterfront home in Florida, a successful business, and a nice car. When she went in for a hysterectomy, she mentioned to her doctor she sometimes suffered from incontinence.
Her doctor told her not to worry. He said he had a new tape and she’d really like it. She was implanted with the Ethicon TVT Prolene polypropylene mesh.
Thirty-six hours after being released from the hospital she was back with a raging flesh-eating infection which almost took her life. Shes undergone nearly 20 surgeries since for infection and mesh removal. She points out that the mesh package insert says Prolene mesh may have to be removed because it can “potentiate an infection.”
Dr. Donald Ostergard has published reports that say mesh is not inert in the body. Produced with antimicrobials, adhesion preventatives and surfactants, it may be impossible to measure the chemical reactions between the polymer mesh and the human body which can lead to a host of problems including chronic inflammation and autoimmune diseases.
BREAKING THE SILENCE
A petition filed by Public Citizen last August joins in the chorus demanding synthetic mesh be recalled from the market and reclassified as a Class III medical device which requires premarket approval application (PMA) that includes data from clinical trials that provide a reasonable assurance the product is safe and effective.
Consumers Union in February of this year launched its Safe Patient Project to urge more rigorous testing on all permanent medical implants before they are marketed and to establish some tracking system not unlike the VIN number on a car. At the present time there is no registry for medical devices.
Most people I interview for MDND don’t even know what kind of device they have until they start requesting pre-surgical notes.
At the present time, it’s easier to track a defective Toyota than a defective implanted medical device.
Like Public Citizen, Consumers Union wants to abandon the 510(k) process and to start some sort of post-surgical registry.
Rep. Edward Markey in his Sound Devices Act, wants to eliminate the use of a predicate device like the ProteGen sling when it has been found defective. Rep. Henry Waxman is requesting the House Energy and Commerce Committee hold hearings, but the requests are falling on deaf bipartisan ears concerned that the medical device industry may suffer in sales and innovation if the protests get too loud.
In an effort to catch up, last January, the FDA ordered 33 mesh manufacturers to begin collecting as much as three years of safety data on the implants.
FEW REMOVAL DOCS
“Mr. Hansen, I am tired. I get up every day dealing with my own painful symptoms and then I read the stories of others. It is too much for me and a tiny group of women to handle alone. We need your help.
I will hopefully have mesh removal later this year by the best and most experience surgeon in the world. I will turn sixty-five in June and at last have Medicare insurance to see this doctor. His name is Dr. Shlomo Raz of UCLA. He knows the truth. He is so booked up with mesh removal surgeries, that is difficult to get an appointment.
“Please Mr. Hansen. Help us.”
~Mesh Patient Writing to Chris Hansen of Dateline
So far the consensus is Dr. Shlomo Raz at UCLA is the premier doctor in the world for mesh removals and approximately 100 – 150 women a month fly in from around the globe to have him peel eroding mesh off of their bladder and spinal column. His assistant, Elizabeth, says Dr. Raz finds a great deal of comfort from the thank you letters he receives from the grateful women.
Meanwhile hundreds of lawsuits against manufacturers have been filed and have been consolidated in the Southern District of West Virginia in multidistrict litigation to be heard sometime in 2012.
Synthetic mesh remains on the market. #