For reporters looking for a way to get started on the transvaginal mesh story, here are some highlights to shortcut your research.
This is not a lawyer-generated story! There are real women suffering devastating injuries from the use of plastic mesh and it continues today! 100,000 product liability lawsuits concerning transvaginal mesh makes it larger than Vioxx, breast implants and Phen-Fen all in one! Please feel free to share this information with any reporters you know.
“We were very shocked and the number of women who contacted us after the story with very similar stories of chronic pain that began shortly after surgery.”
~ Avis Favaro, Medical Correspondent, CTV National News, Ontario, Canada September, 2012
Putting a Face on Adverse Events
This story has the potential to eclipse Vioxx, silicone breast implants and thalidomide combined IMHO! There are 104,000 lawsuits consolidated in one federal court in what's called multidistrict litigation, similar to a class action, as well as hundreds of cases filed in state courts around the U.S. and globally.
I'm a reporter who started looking at these issues in 2009 and could not believe what I found - the perfect storm of aggressive marketers, the doctors who are their audience, and an FDA that is largely hands-off when it comes to regulating medical devices, unlike the more stringent approval pharmaceuticals must undergo.
Injured women are told the pain is "in their head" and sent to pain management or prescribed antidepressants. There are few doctors who can do complete mesh removals or who even recognize the symptoms of mesh erosion, nerve entrapment, or the systemic effects of mesh, a permanent implant. Contrast that with the numerous implant doctors. Mesh manufacturers trained anyone who was interested in increasing revenue to their practice, in weekend cadaver clinics, despite the fact that many doctors did not have adequate surgical skills.
“It is just so unbelievable that a “minor problem” outpatient procedure that is minimally invasive causes life changing results. I know my life as I knew it is gone.”~ mesh injured patient
Reporters are amazed at the number of responses the vaginal mesh stories generate. Women who had been told they were the only one, suddenly realize their symptoms are being experienced by other women.
As a reporter you will hear stories you did not know could exist in modern medicine with few avenues for relief by those who are suffering. Men are suffering too from the same plastic mesh used in hernia repair.
Here is a guide on covering the story.
Transvaginal mesh means it is placed through the vagina. This procedure called “minimally invasive” and it's done to suspend pelvic organs that may prolapse through the vagina, a fairly common condition in women as they age, after multiple vaginal births, due to a hysterectomy, as a result of surgery or due to weak collagen. Pelvic organ prolapse is known as POP.
Many different organs can prolapse in a woman and they include:
Urethrocele- lower vaginal wall and urethra;
Cystocele-upper vaginal wall and bladder;
Uterovaginal – uterus, cervix and upper vagina;
Rectocele- lower posterior vaginal wall and rectum;
Enterocele – upper posterior vaginal wall and small bowel. POP is measured in four stages from zero to 4.
Page four and five of this FDA page shows the female anatomy and what can go wrong.
These are embarrassing conditions many women do not want to talk about. That’s why I called my original series “Suffering in Silence.” The four-part series from 2009 begins here.
Mesh is also implanted in women following a hysterectomy, sometimes prophylactically to prevent a possible future prolapse.
Another condition treated with mesh is stress urinary incontinence (SUI) which occurs when urine leaks during physical activity, coughing, sneezing or laughing. It’s estimated about 13 million American women experience SUI.
It’s estimated upward of 60 percent of women will suffer from one or both of these conditions in their lifetime and the FDA reports that in 2010 about 300,000 women had surgery to repair POP with about 3 out of 4 done transvaginally. Market data also shows that 80 percent of the 260,000 SUI surgeries done in 2010 were done transvaginally with mesh. (FDA White Paper- see below)
Transvaginal or abdominally-placed mesh for POP or SUI is intended to be a permanent implant.
One criticism of mesh often heard is that implanting it transvaginally is a “clean-contaminated” field that introduces bacteria which violates surgical protocol. An early warning about mesh came from Dr. Donald Ostergard who said mesh is not inert and reacts within the body.
See his work here:
Contraction of mesh, scarring, foreign body response, implantation of mesh in areas with ligaments, muscles and nerves continues to incite chronic pain. Many implants cannot be removed, especially the larger POP meshes with arms embedded deeply into tissues. As a result, most of these women cannot work, they lose their livelihood, their homes and their husbands.
"I’m getting booted out of my home to. and I still have at least one or more surgeries left. I pray and pray, I just hope someday this pain will not be with me anymore. I lost my husband during the middle of this, and I know this played on his death, because of his worry for me."
Today's mesh is generally made from polypropylene, a petroleum-based product, or is a composite of pig or cadaver biologic material.
Polypropylene is derived from petroleum and was developed in the 1950s as a thermoplastic polymer resin that can be molded into many forms. Mesh manufacturers molded the plastic into fibers for sutures. Polypropylene knitted mesh using monofilament yarns make textile fabrics and indoor-outdoor rugs.
Nine manufacturers make vaginal mesh including Johnson & Johnson (Ethicon, GYNECARE), C.R. Bard, American Medical Systems, Boston Scientific, Endo Pharmaceutical Holdings, and Covidien, among others.
Before synthetic mesh was used to hold up pelvic organs, doctors were trained to stitch up the falling organs. The main complication from this procedure is a return of the condition, but many women have been complication-free for many decades. Doctors also fashioned a sling or hammock from a woman's ligaments, often from her leg, which provided the perfect biocompatible natural support for sagging pelvic organs.
Synthetic mesh was first used for hernia repair in the 1950s but sometime in the 1990s it began to be used for POP and SUI. By 1996 the FDA cleared the first surgical mesh product for use in SUI and in 2002 for use in POP. The introduction of pre-cut “kits” corresponded with weekend cadaver training sessions offered by mesh manufacturers.
Gynecologists, often not trained surgeons, were schooled by the manufacturers how to implant the plastic mesh with the aid of a kit including pre-cut mesh, needles and sutures.
Almost immediately complications were noted. From 2005 to 2008, the U.S. Food and Drug Administration noted it had received more than 1,000 reports of complications associated with mesh.
They can include:
By October 2008 when the FDA issued a Public Health Notification (PHN) concerning transvaginal mesh, it said there were more than 1,000 reports of adverse events, as the FDA calls complications. The events were serious but “rare,” according to the FDA. FDA 2008 Public Health Notification here.
Then in July 2011, the FDA (here) reported that complications associated with transvaginal mesh to treat POP increased five-fold; that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare” and that transvaginal mesh used for POP repair “does not improve symptomatic results or quality of life over traditional non-mesh repair.”
The FDA issued a White Paper “Urogynecologic Surgical Mesh” about the same time which is an excellent resource here.
It was after this point that lawsuits began to be filed.
A little known loophole buried deep within the administrative jargon of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is called the 510(k) process. The process is used to fast-track the marketing of low to moderate risk medical devices such as wheelchairs, tongue depressors, latex gloves, Class II devices such as catheter, blood glucose monitors and surgical mesh.
No pre-market review is required for approximately 3,000 medical devices approved by the CDRH every year. That means no clinical trials must be presented to assure safety and efficacy unlike the pre-market approval (PMA) process pharmaceuticals must undergo.
Unfortunately with the explosion of medical devices, permanent implantable and high-risk devices are also approved via 510(k). All the device maker must do is name a “predicate device” currently being sold that the new device resembles.
The “substantial equivalent" standard has allowed thousands of medical devices to flood the market with no clinical trials.
DePuy metal-on-metal hips, defibrillators, pacemakers, synthetic transvaginal mesh and hernia mesh are all approved via 510(k). Last year, the Institute of Medicine (here) called 510(k) "fatally flawed" and called for the outdated process to be abolished.
The FDA discussed the IOM report in a September 2011 meeting. The transcript is here:
The recalled ProteGen Sling has served as a predicate device for most of the meshes on the market today. A great resource on the ProteGen predicate was done by a mesh injured woman who I’ve found to be very credible and an excellent researcher. It appeared on iCNN here:
See Diana Zuckerman from the Center for Women and Families, and her excellent piece on 510(k) published in the Archives of Internal Medicine here.
The FDA has a limited budget to conduct medical device reviews as it receives much of its funding from Congress. Some of our representatives feel strongly about the "constituents," namely the medical device industry, especially in states that have a thriving medical device industry.
Even today women are often told the bad mesh is off the market. In most cases this is misleading because the vast majority of meshes are still on the market.
In June 2012, Ethicon (Johnson & Johnson) announced it was discontinuing the sale of four synthetic transvaginal meshes from its Gynecare division. Here is background story from Mesh Medical Device News Desk.
Further evidence the FDA bends to the wishes of industry - The Food and Drug Administration Modernization Act of 1997 narrowed the array of issues that the FDA may consider in a 510(k) review, and directed the FDA to limit, to the “least burdensome” level, the scientific evidence requested to determine substantial equivalence of devices that involved new technologies. That means least burdensome to industry, not to the patient who might be adversely impacted by a defective medical device.
In 2012, Rep. Ed Markey (D-MA) tried to close that loophole with his Sound Devices Act, which would not allow a recalled medical device to serve as a predicate. The Sound Devices Act, supported by Consumers Union, was overwhelmingly defeated by a congressional committee.
Here is a Bloomberg story on using predicates to approve new meshes.
The FDA did attempt to play a little catch up in January 2012 when it ordered about 35 mesh manufacturers to do three years of complication follow-ups on women who have been implanted with mesh. These are called 522 studies and the FDA has limited authority to order the studies when a medical device appears to be injuring patients. At this writing, more than three years later, those 522 studies are in limbo and have not been completed.
There is no national medical device registry in the U.S. Essentially your automobile's VIN # is a better example of how an industry can follow-up when there is a problem. That system does not exist for medical devices at the present time and in the U.S. no one is gathering data at the present time on medical devices when they fail to perform as intended.
Australia has a form of post-market surveillance and it's no surprise that that country was the first to understand that DePuy (Johnson & Johnson) metal-on-metal ASR hip implant was failing because of the many reports coming in. DePuy ASR was later recalled but not before thousands more patients received the implant.
The Problems: No Idea of the Scope of Injuries or Complication Rate
This is another mystery.
The FDA reported in July 2011 that from Jan. 01, 2008 through Dec. 31, 2010, it received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.
But reporting an adverse event by the manufacturer is largely voluntary as the manufacturer can decide if the injury is mesh-related or not. The MAUDE database within the FDA (Manufacturer and User Facility Device Experience) is where a woman or her doctor are supposed to report complications. The actual reported number are thought to represent about 1 percent of real life injuries, according to a government report. That's because the database is little known, and difficult for a patient to navigate.
Here is a MDND story on How to Report an Adverse Event:
(Suffering in Silence- Part 1) finding data on Ethicon’s Gynecare Tension Free family of mesh products involves knowing the criteria:
1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)
2.) Brand Name: Tension Free
3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.
4.) Records Per Report Page: Change to 500 and click Search.”
Without tracking and with few finding the FDA’s MAUDE database and entering their device numbers, there is no way to really know how many women are really suffering complications from transvaginal mesh.
POP and SUI are considered “conditions” and are an inconvenience, generally not painful, but are embarrassing. Most women do not talk about the condition and many find it embarrassing even to talk about complications that result from surgery.
That may be one reason the surgery option continues today; women are embarrassed to speak to their doctor about complications; symptoms may be general in nature and they may not associate the symptoms with mesh; and doctors who receive their primary education from the mesh makers and their representatives, are not equipped in the majority of cases to handle complications.
Women suffering after a mesh implant often hear, “you’re the only one who is having these problems.” Women suffering complications are frequently told they are depressed and told to visit pain management and to take antidepressants. Many women talk of suicide. Some wish they would get cancer, at least it would be a confirmed medical condition.
These stories are repeated over and over. #