Mesh News Desk, July 25, 2018 ~ This story originally ran in March of 2016 but after a conversation today with someone familiar with medical devices, I was surprised to find she thinks many of the problematic mesh is off the market!
This is not true.
Image: Desara Sling by Caldera
Mesh for pelvic organ prolapse (POP) is now classified as class III by the FDA. What does that mean? It means in order to enter the market it must first prove safety and efficacy. Generally that is done with clinical trials, but MND has learned that some of the post-market surveillance may suffice for expensive testing.
What remains true today is that mesh for stress urinary incontinence (SUI) is largely ON THE MARKET, classified as moderate risk by the FDA (class II) and is being sold to women today as a first-line treatment for incontinence.
STILL ON THE MARKET
Johnson & Johnson (Ethicon) still markets:
- TVT – Tension Free vaginal tape. Also known as a “tape” or “hammock”. It is made of polypropylene. In some cases doctors tell patients that this is a “NEW” product or “Not the same one the subject of lawsuits.” Ask- Is it made of polypropylene? See Ethicon brochure here.
- TVT-O Tension free vaginal tape- Obturator (put through the obturator space). Also made of polypropylene, but placed through the obturator opening in the body. Nothing new here. This is classified as moderate risk with the FDA even though it has been found to have been defectively design at trial.
- TVT-Abbrevo mini sling, Implanted transobturator is still on the market. See the product here.
- Gynemesh, used for pelvic organ prolapse, as Artisyn. The polypropylene mesh is used during sacrocolpopexy surgery used to treat prolapse.
- TVT-Exact – A Polypropylene sling mesh kit used to treat stress urinary incontinence. See product here.
Boston Scientific still Markets:
- Advantage Fit– mid-urethral sling to support the urethra made of polypropylene. This is a mesh sling and permanently implanted!
- Lynx Suprapubic – mid-urethral sling- polypropylene
- Obtryx Transobturator – mid-urethral sling, another polyproylene product woven through the obturator space to treat incontinence
- Solyx a single incision sling for treating incontinence
In June, 20017, C.R. Bard was sold to Becton Dickinson for $24 billion, its meshes are off the market. See Mesh News Desk story here.
American Medical Systems
Not to be deterred from the market Caldera offers six meshes to treat stress urinary incontinence, all made of polypropylene and similar to the meshes it’s always had on the market.
Caldera was severely under-insured it was discovered in litigation, and offered mesh-injured patients less than $4,000 each. Here are their products today including Desara, Desara SL, Desara Blue, Desara TV and Vertessa Lite.
Mesh 101: The Basics
For women who have received a transvaginal pelvic mesh implant and have developed complications since then, they are often told “it’s in your head,” or “mesh can’t cause pain.”
These pages are full of thousands of anecdotal reports from women who would argue that point- their mesh implant has caused them real pain and a life-altering complications that sometimes are permanent.
Pelvic mesh, sling, transvaginal mesh, TVT, hammock- some of the names for transvaginal mesh. This is not a lawyer-generated story! There are real women suffering devastating injuries from the use of plastic mesh and it continues today!
Becoming your own best advocate and knowing the facts will help you navigate the road ahead!
How Did We Get Here?
“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
Transvaginal mesh means it is placed through the vagina. This procedure called “minimally invasive” which is a marketing term, 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 increasingly being 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. Mesh to treat SUI is more common than POP mesh.
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.
Transvaginal or abdominally-placed mesh for POP or SUI is intended to be a permanent implant, despite the fact that there were no studies required by the U.S. Food and Drug Administration for safety and efficacy!
That’s right, none.
The majority of medical devices make it to market via the 510(k) approval process, which is essentially an “approval” to sell. All a manufacturer has to do is to say their device is the “substantial equivalent” of another device already on the market. Exchange paperwork, a few thousand dollars, about 60 to 90 days and Voila! Your device is generally approved by regulators at the FDA.
Did your implanting physician tell you the FDA had issued two warnings about polypropylene mesh in the U.S? Health Canada has also issued warnings.
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.
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, 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:
- 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)
“I’m so tired from the struggle & the wait for proper medical attention. My heart is growing weary after five years I am getting worse & scream out to even get up & set down . The getting up is worse , I draw double holding my lower abdominal area where there is an open hole that bleeds.”
By October 2008 when the FDA issued a Public Health Notification 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. See the 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.”
It was after the second FDA warning that product liability or defective product lawsuits began to be filed.
Nine manufacturers are the focus of litigation, they include: Johnson & Johnson (Ethicon, GYNECARE), C.R. Bard, American Medical Systems, Boston Scientific, Endo Pharmaceutical Holdings (AMS), Caldera and Covidien, among others.
The FDA issued a White Paper “Urogynecologic Surgical Mesh” about the same time which is an excellent resource 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.
If you a re experience some of these symptoms, you may want to reach out to an attorney, please click here.
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, even the ones that have been found defective in a court of law!
Those would include the TVT-O (transobturator tape) and the TVT (transvaginal tape).
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.
This was not a recall. J&J said it was making the move for financial reasons.
What was recalled was the ProteGen, a mesh made by Boston Scientific which was the “predicate” named by many of the meshes on the market today. It was found not to functions as intended, in other words it was defective. 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.
However, that finding about the ProteGen did NOT spark a re-review of all of those meshes that had named it as their predicate device. Sort of like a generation of Pinto-like cars being left on the market after the Pinto was recalled!
The federal court began consolidating mesh cases in Charleston, WV in January 2012. This is called multidistrict litigation (MDL) and it is intended to smooth the process for the background research of these cases (called discovery) and to have consistent court rulings.
In an MDL, you are awarded any settlement monies based on your degree of injury, unlike a class action where everyone gets an equal slice of the pie.
But the pace of this litigation has been very slow. So far “bellwether cases” so named for the bell on a lead sheep, which are supposed to test the waters on legal theories and have both sides come to an agreement, have been few and far between. There are now, in early 2016, more than 86,000 case filed in this federal court in Charleston before Judge Joseph Goodwin.
An MDL has never had so many cases filed in one court and frankly the court cannot handle it.
The cases that have been heard are generally favorable to the plaintiff- the woman- who is awarded anywhere from $2 to $100 million. (that number was later reduced to $10 million). Immediately after a jury verdict, the defendant mesh maker will file an appeal. So far only one plaintiff who went to trial has received her compensation.
Right now it appears to be a waiting game with the largest mesh maker, Johnson & Johnson, which is slow to the settlement table and instead has opted to defend itself in court. Other mesh makers have settled cases, though settlement dollars are usually disappointing and not intended to fund a lifetime of medical needs.
From the FDA front, the FDA decided to give mesh makers 30 month to prove their products are safe and effective ( something that might have been done before approval!) or they will have to come off the market. This applies ONLY to POP mesh NOT to SUI mesh. It is assumed mesh makers will have quite the challenge to prove safety so it remains to be seen whether POP mesh will survive. Unfortunately, they have 30 months to continue to use it.
Mesh for incontinence (stress urinary incontinence or SUI) will be allowed to stay on the market. Mind you that there are far more defective product lawsuits filed over SUI mesh, incontinence mesh.
The FDA had stated it would watch the complication reports from SUI mesh instead. Last time this reporter asked, the FDA told me they didn’t know how many injuries were they were receiving concerning SUI mesh.
How to Report an Adverse Event:
Have you ever been curious how the FDA is handling the mesh mess?
Here is where you put in mesh, surgical, polymeric (here). You will pull up many reports made to the FDA about mesh. You can make the report, or your attorney. Make the report then follow up and see if it matches your narrative.
So that leads to this- How to report your injury to the FDA! This is very important to do.
First, know what brand mesh you have (Boston Scientific, Ethicon/J&J/ Gynecare- all J&J). You will get this from your medical records. Get those records!
So how do you report to the FDA? Here is a story from August 2014.
You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online:
- By phone- 1-800-FDA-1088
- By FAX – obtain a fillable form online and print it out and fax it to 1-800-FDA-0178
- By mail – or mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
MedWatch Online Voluntary Reporting Form (3500) is here.
Look up Adverse Events:
Manufacturer and User Facility Device Experience (MAUDE) data
As it stands now, the injured have to find the FDA’s MAUDE database (Manufacturer and User Facility Device Experience Database) and understand the criteria to enter to pull up injuries resulting from your mesh. It can be intimidating, and if they are involved in litigation are generally advised not to enter information.
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.
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 the woman may not associate her symptoms with mesh and doctors who receive their primary education from the mesh makers and their sales reps may not be equipped 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 unending chronic pain, infections and a continuing denial from their doctors.
These stories are repeated over and over.
Editors Note*- the story on Mesh 101 is designed for those women who are just developing symptoms and do not know where to turn. You may want to reach out to legal counsel. ###