Transvaginal Mesh: A Big Seller for Business --- A Nightmare for Women
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Transvaginal mesh (TVM) was touted as a safe product implanted by a simple procedure; it was presented as a product that would proactively solve certain potential or actual health problems women often face. It was sold as preventative or as an easy prophylactic add-on to an already scheduled procedure. But for many women this product has turned out to be a nightmare. This article is designed to introduce the history of TVM and summarize certain strategic considerations when taking on a TVM case. Included, too, is a list of TVM products and corresponding manufacturers.
Background
Since the 1950’s, surgical mesh has been used to support the abdominal wall in conjunction with surgical repairs, such as sports hernias. Product manufacturers later saw an opportunity to take mesh and apply it elsewhere, to solve two problems many women face as they get older.
Stress Urinary Incontinence (SUI): One problem is stress urinary incontinence. This form of urinary incontinence occurs with activities such as sneezing, laughing, coughing, exercising, or really any kind of movement which increases intra-abdominal pressure, which, in turn, increases pressure on the bladder. If the fascia of the pelvic floor is weak, there is not enough support for the urethra. At times of increased abdominal pressure, the urethra moves down and urine then passes.
Pelvic Organ Prolapse (POP): Female genital prolapse, more commonly known as pelvic organ prolapse is the second problem mesh manufacturers sought to address. POP occurs when a section of the vaginal canal or nearby structures fall out of their normal position including sagging into the opening of the vagina. This process can begin to occur when the pelvic floor collapses after childbirth. POP, like SUI, begins to show signs as women age.
Transvaginal mesh is a surgical mesh usually made out of a plastic called polypropylene, which is surgically attached or implanted in the vaginal wall. The makers of mesh have encouraged use of their products to remedy issues associated with SUI and POP. TVM manufacturers created a market for their product by advising doctors that using TVM is a simple process, does not require much training, and is a good business opportunity. Doctors were encouraged to suggest TVM procedures as an isolated proactive procedure or in conjunction with other procedures, a cross-sell, if you will. A woman having a hysterectomy performed can find herself receiving advice that “while the doctor is at it,” he might as well take care of early signs of prolapse. But what was promoted as no big deal has, for many women, become the nightmare of their life. Many of these same women rue the day the mesh was put into their body.
TVM products and the accompanying procedures have created a significant health hazard. The mesh can cause overwhelming pain. In addition, the mesh products are in large part incompatible with this area of the female body: the location where the mesh is inserted is too sensitive and too complicated to handle the insertion of polypropylene. The mesh too, was not designed to work with the particular movements of this part of the body. Often times the mesh degrades, shrinks, and erodes. It can perforate the bladder, bowels, or vaginal wall. It can cause severe infections, sometimes causing death. The mesh can make sexual intercourse too painful for both partners. It can result in incontinence. The list of complications is extensive, and the failings of TVM have become more apparent over time.
The sad irony is that in many instances the product is not even necessary. Some indications suggest that 30% to 50% of all women in their lifetime may develop POP but perhaps only 2% develop symptoms. For those who do have symptoms, non-surgical efforts have historically proved effective in vitiating the need for surgical repair. These include weight loss and Kegel exercises. Additionally, there is no compelling evidence that mesh is more effective than traditional non-mesh surgical repair (colporrhaphy).
The physical impact the mesh creates is only part of the story. Mesh also takes a significant emotional toll. The presence of TVM can impede intimacy. Recovery from the surgery is long, arduous, and sometimes never complete. The mesh product was never designed with any forethought as to what could happen if it needed to be removed. Because the mesh imbeds itself deep into the tissue, it is difficult to take out. Patients frequently need multiple removal surgeries which are often themselves unsuccessful and result in further damage. It is not uncommon for the patient to be worse after a follow-up surgery than they were before.
The FDA
So how did TVM make it to the market? To understand this, we must turn to the oft criticized 510K approval process. Under the FDA’s 510K process, clinical testing for TVM was not necessary. Instead manufacturers availed themselves of the option of claiming that some mesh had already been approved for use elsewhere in the body, such as in the abdomen for hernia repairs; so it was therefore good enough for use in transvaginal procedures. Many TVM manufacturers received clearance from the FDA between 1996 and 2008.
But the mesh for a successful hernia repair in the abdomen and mesh for treating SUI or POP in the vagina present two very different challenges. As early as 1999, reports of complications arising from vaginal mesh implants began to surface. Soon thereafter, one of the manufacturers, Boston Scientific, voluntarily issued a recall of some 20,000 transvaginal mesh implants. However, the FDA continued to approve TVM implants that were substantially similar to those that were recalled.
This discrepancy in the 510K process for TVM has recently received congressional scrutiny. In 2012, U.S. Representatives Edward Markey (D-Mass), Henry Waxman (D-Calif.), Jan Schakowsky (D-Ill.) and Rosa DeLauro (D-Conn.) introduced a bill in the House of Representatives, HR 3847, the Safety of Untested and New Devices Act of 2012 (Sound Devices Act). The act has not become law, but what it would add to the FDA 510K process highlights what is missing and in part explains how TVM managed to flood the market.
The Sound Devices Act (a) provides the FDA the ability to reject a device application based on a predicate that it has been recalled or is in the process of being removed from the market for major safety problems; (b) requires companies to inform the FDA if any products in their new device’s “predicate lineage” have caused serious harm and to explain how their devices avoid past mistakes; (c) instructs the FDA to maintain a publicly accessibly database that companies can use to determine whether a device can be used as a predicate; (d) strengthens reporting requirements so that companies and the public can easily determine why a recall occurred (information that is often missing in the case of voluntary recalls); and (e) calls for the FDA to review the safety of high-risk devices if a product in their “predicate lineage” is recalled due to major safety problems. None of these protections were in place at the time TVM was widely used and clearly a dangerous product flooded the market.
In October 2008 the FDA issued a health alert to doctors, cautioning them about risks associated with TVM while nevertheless characterizing the complications arising from them as “rare.” But, the numbers of complications continued to rise. Finally in July of 2011 the FDA issued a warning regarding the high incidence of complications associated with transvaginal mesh in the treatment of POP. A few months later an advisory panel recommended the reclassification of TVM as “high-risk” so that manufacturers would be forced to undergo rigorous testing. Then, in January 2012, the FDA contacted more than 30 TVM and sling manufacturers and issued an order that they provide three years of data on the safety and the effectiveness of vaginal mesh implants and bladder slings. Manufacturers were also required to conduct safety studies. In response, Johnson and Johnson decided it would discontinue the sales of certain of its TVM products. It cited to sales – not safety – as the reason behind the decision.
Litigation
TVM litigation is active in numerous states, in a Federal MDL (Multi-District Litigation) out of West Virginia, and in certain consolidated state court proceedings. Determining where to file suit and who to file suit against requires advance work-up and careful, thoughtful analysis.
State court litigation: There are no TVM manufacturers headquartered in Washington. This means that state court litigation is an option here in Washington under only two scenarios. One is if there are grounds to sue the doctor. Some of the doctors inserting TVM lacked experience with TVM and/or performing gynecological/urological surgery. In addition, the doctor may be subject to attack for the failure to consider alternatives to the TVM procedure and the failure to consider whether the product they used was safe and effective. Expect the doctor to take the position that the product manufacturer was misleading. Thus, considering a case with the doctor and the product manufacturer as defendants constitutes an exception to a guiding principle that a product case should steer clear of medical malpractice claims.
The second way to file a case in state court is by naming the manufacturer’s sales representative. Many product manufacturers had hands-on sales representatives. Often, these sales representatives were present in the operating room, assisting the doctor, and some even instructed the doctor in the operating suite how to insert the mesh. If the sales representative resided in Washington State (as opposed to traveling from another state) you may be able to include him or her in the case and keep the matter in state court. State court has all the natural advantages any other tort claim enjoys, but it also has the advantage of not getting cornered with some of the challenges that multi-district litigation venues can present. We have already seen a successful example utilizing this state court approach: last June a California jury returned a multi-million dollar jury verdict, allotting 60% fault to the manufacturer and 40% fault to the doctor.
Federal MDL: A judicial panel has transferred cases filed in various federal courts to the U.S. District Court for the Southern District of West Virginia. The MDLs are separated according to the defendant. They are assigned as follows:
- CR Bard, Inc. (MDL 2187, formed on 10-21-10; the Group 1 Bellwether Case trials begin 03-05-13).
- American Medical Systems, Inc. (MDL No. 2325; formed 02-29-12; the next status conference is 12-06-12; the Judge has already ordered submission of bellwether trial plans for trials in 2013).
- Boston Scientific (MDL No. 2323; formed on 02-29-12).
- Johnson and Johnson subsidiary Ethicon (MDL No. 2327, formed on 02-29-12).
- Coloplast (MDL N. 2387; formed 08-20-12).
Litigating in any of these federal MDLs present viable options. The hope is that these TVM MDLs will turn out far better than non-TVM mesh MDLs performed in the past. MDLs are tricky. If you have experience with them, you understand. If you do not, you need to find someone who does. If the product at issue was manufactured by American Medical Systems, Boston Scientific or Coloplast and you do not have a viable Washington defendant, then one of the Federal MDLs may be your best or most viable option.
The Honorable Judge Joseph R. Goodwin is overseeing the TVM MDLs. Earlier this month he issued a pretrial order addressing the submission of bellweather plans, with the idea that trials will start in 2013. Attorneys with TVM cases will want to closely monitor the bellweather trials.
State Court consolidated actions: Because Bard and Johnson and Johnson are headquartered in New Jersey, they are subject to TVM suits in New Jersey state court. New Jersey is considered a quality jurisdiction. The New Jersey TVM cases have been consolidated before Judge Carol Higbee. Filing a case in the consolidated New Jersey proceeding can be a good option for plaintiffs on several fronts. First, Judge Higbee is an experienced mass tort judge – she presided over Vioxx trials against Merck. Second, Judge Higbee has ruled that Johnson and Johnson must turn over its post-market studies, including all communications with the FDA. This latter point is significant because Johnson and Johnson ignored a 2007 communication from the FDA, which called for the company to stop selling TVM until the agency could decide if the devices were substantially equivalent to other products on the market. Third, Judge Higbee has ordered electronic searches of top executives’ communications, including the CEO at Johnson and Johnson, and their depositions.
Naturally, one downside to this approach is that it requires counsel to embrace litigating cases in New Jersey through trial. Regardless of inconvenience, if litigating a suit in New Jersey state court is in the client’s best interest, the client needs to be so advised.
Important considerations
There are a number of other key considerations that one faces in TVM litigation.
Practitioners would be wise to consider a potential mesh implant cut-off date for TVM case intakes. Not every practitioner will reach the same conclusion. For some the cut-off may occur with the July 2011 FDA warning. Others might view the cut-off as occurring in January, 2012. Still others may push this out further. Whatever your comfort level, this is an important consideration before agreeing to take on a case.
Another fundamental challenge entails getting your client to the right subsequent treating doctor. This is no small task. Many doctors are unaware of the problems with mesh or if they are aware of them have not been successful at treating mesh issues. Thankfully, the West Coast has a small number of doctors who are savvy when it comes to the problems that mesh can cause. You will need to learn which doctors have the ability and willingness to assist your clients.
Practitioners will also need to ascertain whether the mesh was inserted via the vagina or via the abdomen. As a general rule, the cases that are worth pursuing are those where the mesh was inserted via the vagina. An exception to this can occur when the TVM procedure occurred at the same time as with another procedure, (e.g., a hysterectomy). Making this determination entails a careful review and clear understanding of the medical records. To that point, do not count on your client to have this all straightened out. You will need to gather and evaluate the records to determine what happened.
Mesh cases that deal with tape are still working their way through the process. A trial is set to occur in California in the next few months. The result of that case is predicted to have an effect on the viability of tape cases.
One should not enter the TVM arena without expecting a vigorous defense from the product manufacturers. Thus far, the manufacturers have fiercely defended the cases. There is no indication that this type of defense will abate.
Commercials advertising for legal representation concerning TVM problems is ubiquitous. As we know, national law firms are often not the best for local clients. The better approach is to connect with an established Washington State firm that handles product liability cases and is litigating TVM cases. An outside law firm is unlikely to even consider the Washington State court path, is unlikely to be able to find your client the subsequent treating doctor they urgently need, and is unlikely to be able to provide the large amount of TLC that these cases require. When women who have endured the nightmare of TVM reach out for an attorney, it will be important to them that their attorney is someone with whom they can meet face to face, who will be available to answer their questions and discuss their case, and who is willing and able to help them.
Conclusion
TVM is a product that never should have been put on the market. It is turning women’s lives upside down. Mesh cases entail understanding complicated science, maintaining awareness of the national litigation picture, and making tough filing and strategic decisions. For those who are willing to dedicate the time, energy, and financial resources to the fight, TVM can be rewarding work.
Vaginal Mesh Manufacturers and Their Products
American Medical Systems, Inc.
Elevate Prolapse Repair System Synthetic Mesh (Polypropylene)
SPARC Self-Fixating Sling System Synthetic Mesh (Polypropylene)
Apogee Pelvic Floor Repair System - Synthetic Mesh (Polypropylene)
Perigee Pelvic Floor Repair System Synthetic Mesh (Polypropylene)
Apogee Vault Suspension System - in both Synthetic Mesh and Biologic (Porcine dermis)
BioArc Sling - Biologic Mesh
IntePro Lite Mesh Synthetic Mesh (Polypropylene)
In-Fast Sling Synthetic Mesh (Polypropylene)
Monarc Subfascial Sling - Synthetic Mesh (Polypropylene)
Miniarc Single-Incision Sling - Synthetic Mesh (Polypropylene)
Boston Scientific Corp.
Solyx Sling - Synthetic Mesh (Polypropylene)
Pinnacle Duet Pelvic Floor Repair System - Synthetic Mesh (Polypropylene)
Uphold Pelvic Floor Repair Kit - Synthetic Mesh (Polypropylene)
Arise Sling - Synthetic Mesh (Polypropylene)
Advantage Fit Sling Synthetic Mesh (Polypropylene)
Lynx Suprapubic Sling - Synthetic Mesh (Polypropylene)
Prefyx PPS - Synthetic Mesh (Polypropylene)
Polyform Mesh - Synthetic Mesh (Polypropylene)
Obtryx Trans-Obturator Sling - Synthetic Mesh (Polypropylene)
Repliform Tissue Regeneration Matrix Mesh Synthetic Mesh (Polypropylene)
C.R. Bard, Inc.
Align Urethral Sling Synthetic Mesh (Polypropylene)
Ajust Single-Incision Sling Synthetic Mesh (Polypropylene)
Avaulta Solo Synthetic Support System - Synthetic Mesh (Polypropylene)
Avaulta Biosynthetic Support System - Biologic Mesh (Porcine acellular collagen matrix)
Avaulta Plus Biosynthetic Support System - Biologic Mesh (Porcine acellular collagen matrix)
Avaulta Biosynthetic Support System - Biologic Mesh (Porcine acellular collagen matrix)
Pelvitex Mesh Synthetic Mesh (Polypropylene)
Pelvisoft Mesh - Biologic Mesh (Acellular Collagen biomesh)
Pelvilace Biourethral Support System - Biologic Mesh (Porcine acellular collagen matrix)
Pelvicol Mesh - Biologic Mesh (Acellular collagen matrix, biocompatible crosslinked porcine dermal collagen)
Uretex SUP Pubourethral Sling - Synthetic Mesh (Polypropylene)
Uretex Pubovaginal Sling - Synthetic Mesh (Polypropylene)
Uretex TO Biosynthetic Support System - Biologic mesh (Acellular collagen matrix)
Uretex TO Transobturator Urethral Support System - Synthetic Mesh (Polypropylene)
Uretex T002 Transobturator Urethral Support System - Synthetic Mesh (Polypropylene)
Uretex T003 Transobturator Urethral Support System - Synthetic Mesh (Polypropylene)
Uretex Dual Knit Mesh - Synthetic Mesh (Polypropylene collagen coated)
Urytex Dual Knit Mesh Synthetic Mesh (Polypropylene)
Interlace Biourethral Support System Biologic Mesh (Acellular collagen matrix, biocompatible crosslinked porcine dermal collagen)
Coloplast Corp.
Restorelle Mesh - Synthetic Mesh (Polypropylene)
Exair Prolapse Repair Systems - synthetic Mesh (Polypropylene)
Novasilk Mesh - Synthetic Mesh (Polypropylene)
Aris Sling - Synthetic Mesh (Polypropylene)
Supris Suprapubic SIing - Synthetic Mesh (Polypropylene)
Altis Single-Incision Sling - Synthetic Mesh (Polypropylene)
Ethicon Inc./Gynecare
Prolift +m Pelvic Floor Repair System - Synthetic Mesh (Polypropylene)
Prolift Total Pelvic Floor Repair System - Synthetic Mesh (Polypropylene)
Prosima Pelvic Floor Repair System - Synthetic Mesh (Polypropylene)
TVT Secur Sling - Synthetic Mesh (Polypropylene)
TVT Exact Sling - Synthetic Mesh (Polypropylene)
TVT Abbrevo Sling - Synthetic Mesh (Polypropylene)
TVT-Retropubic Sling - Synthetic Mesh (Polypropylene)
TVT-O Obturator Sling - Synthetic Mesh (Polypropylene)
TVT Sling - Synthetic Mesh (Polypropylene)
Gynemesh PS - Synthetic Mesh (Polypropylene)
Mersilene Mesh - Synthetic Mesh (Polypropylene)
Prolene Mesh - Synthetic Mesh (Polypropylene)
Mentor Corp.
Ob Tape Sling Synthetic Mesh (Polypropylene)
Tyco Corp.
Covidian Duo - Synthetic Mesh (Polypropylene)
Caldera, Inc.
T-Sling - Synthetic Mesh (Polypropylene)
Desara Sling - Synthetic Mesh (Polypropylene)
