Transvaginal Mesh Discussions Part 1: Medical Conditions Which Precipitate the Use of Transvaginal Mesh

By Independent Staff Writer

Pelvic Organ Prolapse (POP):
Pelvic organ prolapse happens when an organ in the pelvic area drops or prolapses from its normal position and pushes against the walls of the vagina or other organs. Especially in cases where the muscles which hold the pelvic organs in place become weak or stretched from childbirth or surgery, pelvic organ prolapse can occur.  The vagina and uterus are held in place by ligaments, however when the pelvic floor muscles grow weaker the ligaments relax, allowing the vagina to move toward the vaginal opening. 

The bladder and rectum are in close proximity to the vagina, so a prolapse can lead to a loss of bladder or bowel control, difficulty urinating or very frequent urination, a feeling in the vaginal region as though something has dropped, chronic bladder infections, moderate to severe pain during sexual intercourse and chronic pain in the back area. As many as one-third of all women in the United States will undergo some type of treatment for pelvic organ prolapse by the age of sixty, and by the age of eighty at least one out of ten women will have undergone surgery for the prolapse. Pelvic organ prolapse can severely limit a woman’s daily life, yet many women are embarrassed to speak to their doctors about their symptoms.

What Leads to POP?
Age is the primary factor in pelvic organ prolapse; menopause brings about loss of estrogen which in turn leads to loss of muscle tone. Women who have undergone multiple vaginal deliveries or who have a family history of pelvic organ prolapse are more likely to develop the condition as are those who have suffered some sort of pelvic trauma or prior pelvic surgery. Childbirth in particular causes the muscles, fascia and ligaments to separate and weaken as the baby passes through the birth canal and in later years may result in a drop of the pelvic organs from their normal position. Repeated heavy lifting can lead to pelvic organ prolapse as can being significantly overweight.

Transvaginal Mesh Discussions Part 2: Definitions and Descriptions

By Independent Staff Writer

What is Vaginal Mesh?
Although mesh was originally used in hernia repairs as far back as the 1950’s, it was not until the 1970’s that gynecologists began implanting this metallic or polymeric screen to reinforce and support weakened muscle and tissue and treat pelvic organ prolapse. In the 1990’s surgeons used the mesh to treat stress urinary incontinence although there was no “official” mesh product available at the time—surgeons simply cut the mesh to fit the surgical needs of their patients. Finally in 1996 a mesh kit was FDA approved for stress urinary incontinence and in 2002 the FDA approved a similar kit for pelvic organ prolapse surgeries. There are currently four types of mesh, including a non-absorbable polyester mesh (most commonly used), an absorbable synthetic mesh, a mesh made only of animal tissue, and there are meshes which are a combination of the three types above. Women who undergo surgery involving transvaginal mesh will generally have a spinal or general anesthetic. Incisions will be made inside the vagina, then the mesh implant will be placed under the vaginal skin with the expectation that the body’s own tissues will grow into the mesh in a matter of weeks, and the weakened tissues will be successfully reinforced. 

Bladder Sling vs. Transvaginal Mesh Implant
The bladder sling is used in the treatment of severe urinary incontinence. The materials used in the bladder sling surgery include Teflon, Gore-Tex and fibrous tissues taken from the rectum. The surgery can be done through a small incision in the belly button, vaginally, or abdominally. Many surgeons use the sling procedure for all forms of incontinence which affects some 13 million American adults, most of them women. Just like transvaginal mesh, however, the non-woven mesh bladder slings can not only inhibit the flow of oxygen into surrounding organs, it can block crucial nutrients from making their way past the sling material.  This can, in turn, lead to severe pelvic infections and even damage to surrounding organs. Bladder slings can cause many of the same damages that vaginal mesh can, and can negatively impact your future and quality of life. 

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Transvaginal Mesh Discussions Part 3: Problems and Warnings

By Independent Staff Writer

Problems Caused by Transvaginal Mesh Implants
Once the mesh is implanted in the body, it can move around leading to potentially serious injuries in the form of nearby organ punctures or frayed edges of the mesh eating into surrounding tissues. Some women have become septic as a result of the mesh implant, such severe infections, when not treated immediately, can lead to death in some cases. Other common complaints regarding the transvaginal mesh implants include extremely painful intercourse, scarring in the areas surrounding the mesh implant, a recurrence of the original pelvic organ prolapse, and chronic urinary infections and problems.

It is estimated that erosion of the transvaginal mesh implant into surrounding organs and tissues occurs in about 10 percent of all women who have undergone vaginal prolapsed repairs using mesh. In some cases the mesh material can be removed during another surgical procedure, however in some cases tissue may have grown in and around the mesh leading to multiple surgeries or interventions. Many women are not fully informed about alternatives to mesh implants, nor are they informed about the possible risks of transvaginal mesh implants.

Has There Been a Recall of Transvaginal Mesh Implants?
There are currently many, many manufacturers of transvaginal mesh, however the majority of the negative reports regarding the mesh center around the following mesh brand-names along with the manufacturer. Gynecare, Gynemesh and Ethico are Johnson and Johnson products, Avaulta, Pelvicol and Pelvisoft are manufactured by C.R. Bard, The Advantage Sling, Obtryx, Perfyx and Pinnacle are made by Boston Scientific, and Spar, Miniarc, Monarc, Apogee, Perigee and Elevate are made by American Medical Systems. It appears that the use of surgical mesh to treat pelvic organ prolapse or SUI may never have been sufficiently tested; after gynecologists began using mesh in their surgical applications in the 90’s the FDA approved the mesh under a 510(k) clearance “loophole,” meaning the mesh was approved without proper testing and clinical trials.

The pelvic transvaginal mesh types currently bringing so much concern are very similar to the ProtoGen mesh which was recalled over a decade ago. In October of 2008 a Public Health Notification was issued by the FDA cautioning physicians about potential health issues resulting from the implantation of transvaginal mesh. At this point the FDA had received hundreds of reports of negative health issues from use of the transvaginal mesh implant. It was not until July of 2011, however, that the FDA issued an updated safety warning which indicated serious complications could arise from the use of transvaginal mesh implants, and that those complications were “not rare.” 

Transvaginal Mesh Complications and Corrective Procedures: The Long Road to Recovery

By Independent Staff Writer

In the past few years more and more women are coming forward to report complications—some of them quite severe—which resulted from surgeries involving the use of transvaginal mesh implants. Mesh has been implemented in surgeries as far back as the 1950’s, when it was used in hernia repair over the more traditional suture repair, with excellent results. In fact, when the mesh procedure was used there was a significantly lower recurrence of the hernias.

Doctors soon began using the mesh in other applications such as the repair of pelvic organ prolapse and stress incontinence, simply cutting it to the size needed. Unfortunately, due perhaps to the difference in elasticity between the abdominal area  and pelvic area, many women have reported medical issues following their mesh surgery including severe infections, pain in the pelvic region, adhesions, mesh erosion, chronic urinary tract infections, bowel and bladder injuries, painful scarring, painful sexual intercourse, and even death in a few tragic cases.  Correcting these injuries can require one or more surgeries performed by a surgeon with training and experience in mesh injury surgeries.

Mesh Extrusion or Erosion
The most common complication of the transvaginal mesh placement occurs when the mesh breaks through the incision or the vaginal lining, resulting in bleeding, excess vaginal discharge, recurring urinary tract infections, drainage of urine into the vagina and can even cause pain to a male partner during intercourse. The exposed mesh as well as the surrounding injured vaginal tissue must be removed followed by pelvic reconstructive surgery. Some of the most highly skilled surgeons in the country are implementing a new surgical instrument known as the Plasma Blade in favor of the more traditional scalpel or cauterization devices, however it can be difficult to find a surgeon trained in using this innovative instrument.  

If the mesh has eroded into the bladder, it must first be removed, then the damage to the bladder and the vaginal wall must be repaired, usually through the abdomen with a fairly large incision and a relatively long recovery time. Depending on the extent of the erosion some doctors perform the procedure laparoscopically, which is typically an outpatient surgery done through a mini-incision in the belly button. Performing the repairs in this manner is considered an advanced procedure and should only be attempted by a surgeon who is highly experienced in the technique as well as the necessary pelvic reconstruction. Should the mesh have eroded into the bowel or rectum it is considered a very serious complication.

Transvaginal Mesh: Is an FDA Recall on the Horizon?

By Independent Staff Writer

Even though some consumer advocate groups—such as Public Citizen—have called for the FDA to ban the marketing of transvaginal mesh for use in surgeries such as the repair of pelvic organ prolapse and stress urinary incontinence as yet there has been no definitive conclusions reached as to whether the use of mesh should be permanently discontinued. The FDA has made physicians and the public aware of the potential risks involved in using transvaginal mesh including erosion, contraction or shrinkage of the mesh once it has been implanted, however now must decide whether further action is called for in light of the flurry of lawsuits regarding mesh complications.

It is highly unlikely that the manufacturers of the mesh will issue a voluntary recall, although the FDA may choose to elevate the approval process for the mesh from the moderate risk Class II to the higher-risk Class III. If the mesh device class is reclassified, manufacturers will face a much tougher process when gaining FDA approval and will also be required to conduct human trials.  A Class III is the highest risk category for medical devices however the FDA could conceivably bump up the existing class level without recalling existing devices. Finally, the FDA could issue sterner warnings regarding the mesh devices to both physicians and patients while allowing the device to keep the same approval process, meaning that new mesh products which are substantially equivalent to already-approved ones would be granted approval.

FDA Safety Recommendations
Currently the FDA has issued safety recommendations and warnings regarding the use of transvaginal mesh implants including:

• Patients who have pelvic organ prolapse surgery using mesh may be subject to complications which are not experienced by those undergoing more traditional forms of POP surgery without mesh.

• Placement of the transvaginal mesh patch may be life-altering for some women, and the chronic levels of pain can sometimes continue even after the mesh is surgically removed.

• Mesh-associated complications are not rare—approximately ten percent of women who undergo pelvic organ prolapse surgery with mesh experienced some level of erosion within the first year following the surgery.

• Erosion is the most common complication, and of the women who experienced erosion of the mesh into the vaginal wall or other organs, more than half required surgical excision of the mesh with some requiring multiple surgeries.

• Many women have reported mesh contraction which results in chronic vaginal pain or vaginal shortening.

• When mesh is used in stress urinary incontinence surgeries recurrence of the SUI is more common than in traditional repair which doesn’t use mesh.

• When mesh is used to perform a pelvic organ prolapse surgery abdominally, it appears to have lower rates of complications as compared to transvaginal surgery with mesh.

• As far as effectiveness, the FDA states that transvaginal repair with mesh does not appear to provide any added benefits compared to more traditional surgeries without mesh.

The FDA goes on to state, however that so far the adverse events which resulted from transvaginal mesh surgeries were both inconsistently defined and reported, that very few of the existing studies extended longer than two years, and that the studies which exist tend to be poorly designed, poorly conducted and fail to account for variable patient follow-up length. The results from the few studies which exist reflect both primary and repeat prolapse repairs which could skewer the overall results.

Transvaginal Mesh: The Types of Surgeries Which Use this Controversial Device

By Independent Staff Writer

As more information comes to light regarding the potential safety issues of the transvaginal mesh implants, women across the nation have more questions regarding the device. The FDA has yet to make a final determination on how mesh devices will be approved in the future and whether the current manufacturers will be subject to more rigorous scrutiny regarding the mesh device. It appears that there are now thousands of women coming forward with stories of adverse events following their transvaginal mesh surgery leading the FDA to require sterner warnings regarding use of the mesh. Physicians are being warned to strongly consider alternative or more traditional surgical methods in repairing pelvic organ prolapse and stress urinary incontinence and women are urged to be fully informed of potential risks before undergoing transvaginal mesh surgery.

Hernia Repair Using Mesh
The mesh used in many surgeries today was originally used strictly for abdominal hernia surgeries and appeared to work well in this application although there were some complications reported. The patch for a hernia repair is typically larger than one used in a transvaginal application so remains in place more securely. Studies show that a Type I mesh tends to be tolerated better, resulting in the fewest complications when used in hernia, POP and SUI surgeries, and infections using this type of mesh are rare. Type I meshes are monofilament and somewhat porous, which allows the body’s bacteria-fighting cells to have unimpeded access to the mesh implant. Mesh made of Gore-tex has been shown to cause the highest rates of infection and erosion therefore is being used less and less often in the transvaginal application.

Necessity for Pelvic Organ Prolapse Surgery
In a woman’s twenties and thirties her natural connective tissues and ligaments will hold her pelvic organs firmly in place.  As women age and undergo pregnancy and childbirth, those connective tissues begin to stretch out of place, allowing the descent of one or more of the pelvic organs including the uterus, vagina, bladder or rectum. The fascia in a healthy pelvic floor is comprised of a natural elastic mesh layer which keeps the organs where they should be. When this fascia begins to break down and weaken, organ prolapse can occur in varying degrees of seriousness. It is estimated that as many as half of all women who have had at least one full term pregnancy have some level of pelvic organ prolapse.

Risk Factors for Pelvic Organ Prolapse
The known risk factors which increase the odds of pelvic organ prolapse consist of the ever-present genetic link, menopause, being older than sixty, previous pelvic surgery or surgeries, number of full-term pregnancies as well as issues associated with increased stomach pressure such as being overweight. Even though fifty percent of women who have gone through childbirth may have some level of POP, most of them do not have symptoms so severe as to require surgery.

For those women who do have symptoms severe enough to affect their overall quality of life, they may need to have some form of surgical treatment to alleviate the pain and other symptoms. It is necessary to fully evaluate each woman’s individual case before deciding on a course of action. The length and severity of the symptoms will of course be a factor as well as the woman’s desire for treatment the degree of the prolapse and whether or not she is healthy enough to undergo surgery.

Becoming part of a mass action lawsuit over the DePuy hip implant gives you an edge that going solo can't afford.

By Independent Staff Writer

Many different law firms are suing DePuy Orthopaedics over the faulty ASR XL Acetabular System. In a personal, vulnerable situation like this hip implant case, it can be difficult to assess the situation and make the right legal decision for you. In this article, we'd like to break down the difference between mass action, class action, and solo cases so you can make a well-informed choice for yourself.

"One Riot, One Ranger"

When a single person with a single lawyer brings a case against one organization, our firm's Andrew Sullo likes to call it a "one riot, one ranger" case: one person was harmed, and one person needs to set it right.

Let's take a hypothetical. Company X has a trucking business. One of its drivers runs into a pedestrian and causes serious injury. The driver was clearly negligent and the pedestrian was clearly hurt. The damages amount to $1 million. If the lawyer presents a good case, it's likely that the case will be settled for the $1 million, and Company X won't bother spending much on its own legal defense.

Company X could, of course, spend $1 million to avoid paying the $1 million to the plaintiff, but this would take up time, company resources, and would likely land them some bad press. If the money will be spent anyway, it's in Company X's best interest to simply pay the plaintiff with it instead of using up those resources.

"One riot, one ranger" is a very effective way to settle a case with a single client who has a single complaint, because it simply isn't worth the legal fees to Company X to defend the case when it can be settled for its fair value. They would rather settle the case, reluctantly compensate the plaintiff for his injury, and move on.

So if "one riot, one ranger" cases are effective, why isn't that the best way to bring a case against DePuy for their faulty hip implant?

If a single person had received a single faulty hip from DePuy, it would be a great way to bring the case. Unfortunately, we're dealing with 93,000 people who received recalled hip implants, many of whom will now have medical consequences.

And in that situation, the math starts to work against the plaintiffs.

Bluffing Without a Hand

Going back to Company X for a moment, let's say that instead of the truck running into a single pedestrian, the truck ran into a plane full of people. 200 people are seriously injured. Each of those 200 people runs out and gets a lawyer. The cost of the injuries is far beyond our original case scenario - perhaps a few people have injuries totaling $1 million worth of compensation, but others will have lower or higher damages.

Instead of paying a one-time settlement of $1 million, Company X is now looking at paying several hundred million, because there are so many people to settle with.

Suddenly, shelling out a couple million in lawyer's fees to defend against the lawsuits is a much better deal for Company X.

Each individual lawyer (assuming they are working on a contingent fee basis) will have to put up his or her own money to fight the case. Company X can afford to put a lot more money into the case than the lawyers can because they are ultimately saving themselves from the even more expensive consequences of settlement.

One plaintiff might have a $10,000 case, and the plaintiff's lawyer might be willing to put in up to that amount of his own money to see justice served. But Company X can afford to put in millions - even if the case isn't actually worth that amount - just so they won't have to settle with the other 200 individual cases as well.

In a case where there are many people who have been harmed, it's a case of "divide and conquer." The more lawyers who are depending only on their own funds to bring a case against Company X, the more power and leverage Company X has. They know the lawyer can only afford to put in a certain low amount of money, so when the bargaining starts, the lawyer is bluffing with a bad hand. Company X knows it can outbid him. The lawyer knows Company X can outbid him. He's got nothing to bargain with.

Enter the mass action lawsuit.

The U.S. Food and Drug Administration’s Letter to Hip Makers Mean

What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?

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The U.S. FDA ordered 21 manufacturers to collect information from patients.

The U.S. FDA ordered 21 manufacturers to collect information from patients in a recent letter to hip manufacturers. Click here for report. The three-page letter demands blood tests and other studies within thirty days. Here is a summary of the information and questions the FDA is requiring from manufacturers:

• The harmful events observed in patients with Metal-on-Metal (MoM) total hip replacement (THR) systems.
• The levels of serum and chromium in patients prior to THR.
• The patient population's average levels of chromium and serum in the blood for a minimum of eight years after the implant (patient population is the demographics and other particulars of a particular population).
• Do the average levels of chromium and serum in the blood increase during the first eight years (or the length of time on the market)?
• Reasons for revision (alteration of a medical device) and patient population's average levels of chromium and serum in the blood at the time of the revision.
• The number of patients with pain and biological and psychological symptoms associated with the THR.
• The quantity of harmful reaction of body tissues in patients who did not have a revision.
• How differences in revisions vary over time after the initial implant?
• What demographics have higher metal ion concentrations in their blood?
• What demographics have higher risks of needing revisions?
• What causes the THRs to fail?