Reporters Resource on Covering Mesh IssuesAug 31st, 2012 | By Jane Akre | Category: Mesh Reading Room Resource
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!
“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! 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, unlike pharmaceuticals, is largely hands-off when it comes to regulating medical devices.
Injured women are told the pain is “in their head” and sent to pain management or prescribed antidepressants. Many women are confused whether or not their pain is mesh-related. There appear to be 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.
“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 I’ve spoken to were 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.
Why is it Used?
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:
What is Surgical Mesh?
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.
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.
Editors Note* (additions added from my own research) Within the medical field, trained surgeons like to brag that they knew how to cut their own mesh to fit the patient and look down at the mesh kits and the newly trained surgeons who relied on them as a way to expand one’s practice for additional financial gain.)
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:
- Erosion through the vaginal epithelium and tissues;
- Perforation of bladder, rectum,
- Urinary problems;
- Internal bleeding;
- Recurrence of prolapse and/or incontinence;
- Vaginal wall narrowing
- Nerve entrapment
- Vaginal scarring;
- Dyspareunia (painful sexual intercourse)
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.
Things changed dramatically over the next five years.
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.
The Problems: A Safety Loophole
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 medical 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.
The Problems: Recalls
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.
The ProteGen Sling was voluntarily recalled by Boston Scientific in 1999 for being “misbranded and adulterated” in other words, defective. The Ob Tape, made by Mentor (now Johnson & Johnson) was removed from the market in 2006. Despite that it is still named as a predicate device!
Within the FDA there is no mechanism to trigger an automatic review if a predicate, such as the ProteGen, is recalled for safety issues.
In June, Ethicon (Johnson & Johnson) announced it was discontinuing the sale of four synthetic transvaginal meshes from its Gynecare division. It did not call the withdrawal. Here is background story from Mesh Medical Device News Desk.
The best known hernia mesh recall was the Kugel which was made with a plastic ring which broke in many hernia patients. Kugel mesh was recalled, redesigned, and put back on the market where it remains today. Those lawsuits are in the settlement stage.
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. Those 522 plans were supposed to have been submitted within 60 days but as of July 2012, they had not been submitted.
The Problems: No one is Watching
There is no national medical device registry in the U.S. Essentially your automobile and its VIN# represents an example of how a followup can happen if a product is defective, but that system does not extend to medical devices at the present time.
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.
In the U.S. no one is gathering that data at the present time.
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 is supposed to report her complication. 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. She or he must have full and complete information including the classification of the device and its lot number. Some injured patients do not even know they have mesh or do not have their complete medical records which includes that information.
Here is a MDND story on How to Report an Adverse Event:
For example, in the case of mesh patient, Suzanne McClain
(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.
We do know that one clinical trial was suspended when 15.6% of the participants began having complications. Ethically the trial had to be suspended. Here is a background story.
Five lawsuits have been consolidated in the Southern District of West Virginia in multidistrict litigation. Another is being heard in the Middle District of Georgia. There are state actions filed around the country. Altogether there are thousands of litigants.
In August, 2012, the first landmark state case against Bard was heard by a Bakersfield jury who awarded Christine Scott and her husband $5.5 million for her injuries from a transvaginal mesh. Bard announced it would appeal.
The Problems: How Women are Treated
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. #