A $3.35 Million partial verdict was handed down in first vaginal mesh trial.  This is good news for women who have suffered from a vaginal mesh implant. The Vaginal Mesh helpline hears horror stories every day and we applaud our first victory as the pathway to help other women whose lives have been ruined by the Prolene mesh. Vaginal mesh lawyers have been watching and agee this is good news for future trials.

The jury declared that  Johnson & Johnson should pay a South Dakota woman $3.35 million for failing to adequately warn her doctor of the potential dangers of a vaginal mesh implant made by the company’s Ethicon Inc subsidiary, and for misrepresenting the product in brochures.  It is the first verdict among some 1,800 vaginal mesh cases pending in New Jersey against Ethicon and J&J, and can potentially  set the way for  thousands of lawsuits and trial outcomes against  manufacturers of vaginal mesh implants.

February 25, 2013

ATLANTIC CITY, N.J. — A New Jersey state court jury has handed down a partial verdict of $3.35 million against Johnson & Johnson (NYSE: JNJ) and its subsidiary, Ethicon Inc., at the end of the first pelvic mesh case to go to trial, Harris Martin Publishing is reporting.

In a Feb. 25 verdict, the jury found by a 7-2 vote that the manufacturers failed to adequately warn plaintiff Linda Gross’s implanting surgeon of the risks associated with the pelvic mesh and, additionally, that the device was the proximate cause of injury. By a 7-2 vote, the jury  was on our side.

We have been listening to 1000′s of women over months calling from all states and of all ages. Their marriages have been destroyed and they are suffering. The youngest was 33 and the oldest 86. We have heard from women, mothers, daughters, grandchildren , and friends for friends that are so debilitated they cannot come out of bed to call on their own. They need help from doctors and cannot afford surgeries to “Get the damn thing out”.

We demand justice on behalf of these women and are happy to see it is starting to happen. Can money change this? Atleast is will pay for medical care and send a message that manufacturers that use women to gain profits must end.

The first transvaginal mesh trial against C.R. Bard and its Avaulta Transvaginal Mesh product was set for February 5, 2013. The push is on to get Bard’s device and other vaginal mesh products off the market before they can do further harm. The Vaginal Mesh Helpline I watching and waiting with hopes of justice for the many women suffering from:

• Erosion of the mesh through the vaginal  wall
• Relentless  pain
• Exposure or extrusion of mesh
• Lower back pain and razor blade pain
• Painful sexual intercourse
• Perforation or puncture of the bladder, intestines and bowels, as well as blood vessels around the vaginal wall
• Recurrent Pelvic Organ Prolapse (POP)
• Recurrent Stress Urinary Incontinence (SUI)
• Urinary problems
• Vaginal bleeding
• Constant  discharge and infections
• Ruined lives and marriages
• Vaginal scarring and shortening

The First Stage of the Avaulta Mesh Lawsuit Trials

Dr Uwe Klinge, a world-renowned expert on the biocompatibility of surgical mesh, explained to a jury during a talk he delivered in 2005 to J&J. Dr Klinge told the manufacturer’s Ethicon unit that surgical mesh could only be safe for patients when used in the pelvis if it was very lightweight and had pores that were at least 1 millimeter in all directions. But Ethicon chose to ignore his advice. They marketed the Prolift vaginal mesh kit made with mesh that was larger and heavier than Dr. Klinge said it needed to be for patients’ safety.

We hope for a positive outcome for thousands of women harmed by failed mesh products. it is not too late for you if you have a Bard vaginal mesh. The outcome of this trial is just the beginning. File your mesh lawsuit today.

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Vaginal Mesh Helpline is keeping women informed with a mesh update on the all the new  vaginal mesh lawsuits. All vaginal mesh lawyers suggest filing your mesh lawsuit  right away. We do not want any women to be left out.

A 47-year-old former nurse, Gross testified that Ethicon’s Prolift vaginal mesh implant has rendered her unable to work, have sex with her husband, or sit comfortably for more than 20 minutes. (Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey.) Gross also said that, as a result of the Prolift mesh, she takes up to 20 medications a day and has undergone more than 400 medical encounters, including physical therapy sessions, doctor visits, and many surgeries.

The Charleston woman claims that she suffered serious complications after AMS surgery, when she was implanted with the Elevate transvaginal mesh back in January 2011. The lawsuit alleges that she suffered substantial physical pain and suffering, emotional distress, and economic loss due to medical expenses. These damages, according to the suit, were the direct result of the AMS transvaginal mesh manufacturer’s negligent and wrongful actions. Further, the defendants, AMS, allegedly knew about the risks involved with its transvaginal mesh product but failed to warn the plaintiff.

A Georgia women’s  doctor suggested the mesh when she mentioned that she had bladder leakage when she laughed or coughed. Shortly after the surgery, it felt like razors were slicing her organs and a sharp edge of the mesh cut her boyfriend during sex, she said. Even though she eventually had it removed, the 55-year-old west Georgia woman still has pain she believes is caused by the mesh.

According to court documents, on January 7th, 2013 a Minnesota woman filed a lawsuit in Minnesota District Court (case no. 0:2013cv00060) alleging she suffered serious complications from her Transvaginal Mesh. Transvaginal surgical mesh is used to treat pelvic organ prolapse (POP) and Stress Urinary Incontinence (SUI). Defendant is Boston Scientific and in the lawsuit, plaintiff claims that after surgical implantation with defendant’s Lynx sling she suffered complications.

Vaginal mesh Bell Weather Case Updates

The  first bellwether trials in the Transvaginal Mesh MDLs have been scheduled to start in December 2013. Defendants in the first three bellwether trials are American Medical Systems (AMS), Boston Scientific and Ethicon. (American Medical Systems is referred to as MDL 2325).

FDA Adverse Incident Reports On the Vaginal Mesh

The FDA received more than 1,000 complaints associated with trans vaginal mesh between 2005 and 2007. That number almost tripled between 2008 and 2010.

The Vaginal Mesh stories of suffering go on and on with more women filing lawsuits every day. The Vaginal Mesh Helpline has a mission, We must locate all women suffering from these Prolene mesh implants after 2001 and get them to a mesh lawyer to file their transvaginal mesh lawsuit today.

Be aware that all these devices have fancy names but they are all mesh. If you have a Prolene product implanted in you for prolapse or urinary incontinence call the Vaginal Mesh Helpline today. It is most likely one of these mesh devices that women are  filing vaginal mesh lawsuits for nationwide. Be aware you must move quickly. Statute of limitations for states are running close. If you have a current mesh lawyer call today and get and update. Find out who has your vaginal mesh file. Many lawyers may have referred your case out. Find out if your lawsuit was filed. Since the mesh is now a consolidated MDL it is extremely easy for lawyers to file the lawsuits. The Bellwether trials will begin soon…Do not be left out. Stay on top of things. if you need help or have questions call the Vaginal Mesh Helpline today. If you have received a rejection letter from a law firm do not give up hope. call us about your vaginal mesh lawsuit today. We will make every attempt to locate a vaginal mesh lawyer for you to take your case. But, these must be mesh implanted after 2001, closer to 2002.

The Vaginal Mesh Helpline will keep you updated on all the most recent news. Our vaginal mesh network of lawyers is filing mesh lawsuits on behalf of women with a failed Prolene mesh. The mesh was used for urinary incontinence in 100's of women.

Published on Saturday 15 September 2012 21:02

Botox injections may help women with urinary incontinence, The Daily Telegraph has today reported. The newspaper said that injecting the muscle-freezing toxin into the wall of the bladder can have a long-lasting impact on overactive bladder syndrome, a major cause of incontinence.

The newspaper’s story is based on a UK medical trial that investigated whether the paralysing properties of botox were effective at reducing the symptoms such as frequently using the toilet, feeling an urgent need to urinate, and leakage in patients with overactive bladder syndrome.

The trial featured 240 women who had not responded to medical treatments for overactive balder syndrome. The researchers found that women who received the botox injection experienced these symptoms significantly less frequently than women who received a dummy injection of saltwater. However, women given botox were more likely to get urinary tract infections.

The results of the study indicate that botox may be effective in treating a common and upsetting health condition. However, if it does get adopted into use in this way there are several other treatment options (including lifestyle measures, bladder training exercises and medication that would be considered first. Botox may be considered as an option only if these treatments fail, and the benefits would have to be considered in relation to its potential harms.

Where did the story come from?

The study was carried out by researchers from the University of Leicester and was funded by the Moulton Charitable Trust and the women’s health charity Wellbeing of Women.

The study was published in the peer-reviewed medical journal European Urology.

The Telegraph covered this study appropriately, covering the study size and design, as well as the treatment benefits and harms.

What kind of research was this?

While it is hard to gauge the true scale of the problem, research suggests that around 13% of women in the UK may have some form of urinary incontinence. Although many conditions and factors can cause urinary incontinence, one major cause is overactive bladder syndrome. The condition is marked by uncontrolled contraction of the bladder that results in an urgent need to pass urine. While this can lead women to need the toilet frequently, some also experience a form of leakage called urge incontinence.

An overactive bladder can be a cause of urge incontinence, which is when urine leaks at the same time or just after you feel an intense urge to pass urine. Urge incontinence differs from stress incontinence, where the pelvic floor muscles are too weak to prevent urination. This causes urine to leak when your bladder is placed under pressure from actions such as coughing or laughing.

This was a placebo-controlled randomised controlled trial that examined the effectiveness and safety of using botulinum toxin (botox) as a treatment for overactive bladder syndrome. A randomised controlled trial is the best way to measure the effectiveness of a treatment, as the randomisation process helps to ensure that any patient characteristics that may influence the outcome have an equal chance of appearing in either treatment group. This allows researchers to be confident that any observed effect is due to the treatment under study.

What did the research involve?

The researchers enrolled 240 women with bladder muscle overactivity, or overactive bladder syndrome, that had not responded to previous treatment. The women were randomly allocated injections of either Botulinum toxin A (botox) or placebo (saltwater) into the wall of the bladder. Women with another common type of incontinence, stress incontinence, were not included in the study.

The participants kept a diary over three days, recording the number of times they:

    emptied their bladder
    felt an urgent need to empty their bladder
    experienced an unintentional passing of urine (or leakage)

The women also completed a questionnaire that assessed their quality of life, as overactive bladder syndrome often has a significant negative impact on patient quality of life.

The researchers conducted follow-up sessions with the women on average at six weeks, three months and six months after treatment. They assessed differences in the frequency of the above three symptoms between the two treatment groups. They also compared quality of life scores, treatment complications and time until troubling symptoms returned between the two groups.

The researchers used appropriate statistical methods to assess differences in frequency of symptoms between the two groups.

What were the basic results?

There were 122 women allocated to the botox treatment group and 118 women allocated to the placebo group.

The researchers compared the outcomes in the botox and placebo groups at the six-month follow-up. They found that in any 24-hour period women in the botox group:

    emptied their bladders less often: 8.33 times versus 9.67 times, a difference of 1.34 (95% confidence interval [CI] 1.00 to 2.33, p=0.0001)
    experienced fewer leakage episodes: 1.67 versus 6.00, a difference of 4.33 episodes (95% CI 3.33 to 5.67, p<0.0001)
    experienced fewer episodes of urgency to urinate: 3.83 versus 6.33, a difference of 2.50 episodes (95% CI 1.33 to 3.33, p<0.0001)

Almost a one-third of women in the botox group (31.3%) developed bladder control (or continence) following their treatment, compared to 12.0% in the placebo group (Odds Ratio [OR] 3.12, 95% CI 1.49 to 6.52, p=0.002).

However, urinary tract infection was reported at least once during six months by a one-third of women in the botox treatment group, compared to 10% in the placebo group (OR 3.68, 95% CI 1.72 to 8.25, p=0.0003).

Those given botox also reported greater difficulty emptying their bladders, which required self-catheterisation to remove their urine: 16% of the botox group compared to 4% of the placebo group (OR 4.87, 95% CI 1.52 to 20.33, p=0.003).

How did the researchers interpret the results?

The researchers concluded that injections of botulinum toxin A into the bladder wall is an effective and safe treatment for overactive bladder syndrome in women who have not responded to previous treatment.

Conclusion

Urinary incontinence can be a distressing and problematic condition, and although we cannot be sure of the number of people affected, research suggests it is surprisingly common.

While there is a range of potential treatments and ways to manage urinary incontinence (including medication, bladder training, lifestyle changes and surgery) not all people respond to them, and they can have problems. This randomised controlled trial provided good evidence that botox injections may be a useful treatment option for women with incontinence due to overactive bladder syndrome that has proven difficult to treat with other methods.

The researchers say that the relief of symptoms reported by the participants was considerably better than those who used oral anticholinergic drugs. These drugs act on the nerve supply to the bladder and are the standard medical treatment used for this condition. They add that other randomised controlled trials have reported similar effects.

The researchers say that since they designed their trial, other studies have published results that support using a lower recommended dose of botox for this type of treatment. Therefore, it is unclear if the same results would be found at this reduced dose. They also say that their study recruited participants with severe cases of overactive bladder syndrome, and that it is unclear if the treatment would be as effective in less severe cases.

It is important to note that the study participants did not have stress incontinence, which is a common cause of urinary incontinence. Therefore, the results of this study cannot be generalised to all women with symptoms of overactive bladder or incontinence, but can only be applied to those with diagnosed overactive bladder syndrome (or detrusor overactivity).

Botox is not routinely used by the NHS in this way, but if it were then it would probably be considered as an option only among women who have required specialist referral for their condition. This would be given after they had tried other treatment options first, which may include lifestyle measures and bladder training exercises in addition to oral medications. If these treatments fail, the benefits of botox would have to be considered in relation to its potential harms.

The Vaginal Mesh  Helpline speaks to and hears from women daily regarding their mesh stories. These are all usually the same pain, complications, symptoms and suffering. More importantly there is usually doctor. Usuallyb there are many doctor visits. Doctor after doctor visits are happening to all types of medical specialties. What  resonates across most of these phone calls is doctors sending women for tests that show a lack of knowledge of the mesh.  The mesh has very basic symptoms that can effect the pelvic area, bladder, bowel, uterus, abdomen, lower back, legs and the entire body from the waist thru the legs and lower back. These are all classic mesh symptoms. The symptoms are being caused by mesh erosion and infection. Sometimes it is from perforation or an organ. But, The most important thing is getting a doctor that understands the mesh and is not afraid to admit you have a faulty vaginal mesh problem. You have had these symptoms for months, sometimes years and a T.V ad has just shead the light. "OMG" It is not in your head. You are a victim of a failed vaginal mesh.

 Step One:  Find a doctor with experience in mesh removal.

The most experienced are usually urogynecologists. In any event they must have experience in mesh removal for you to be sure they understand the problem

Step Two: Hire a lawyer before your statute of limitations runs out

Choose a law firm with experience handling surgical mesh lawsuits. Most firms should provide a free consultation where an attorney will discuss how the case would proceed should you decide to pursue legal action. The firm should have experience in mass torts and take youyr case on and individual contingency basis. They should be keeping your case and not referring it out. The usual and customary fee is 40%.

Step Three: Attempt to get your medical records

These are most likely obtained at the hosptial where the surgery was done. Do not be alarmed if your doctor is not thrilled at turning your records over. Your lawyer can help

Vaginal mesh lawsuit lawyers of Florida including: Belle Glade, Boca Raton, Bonita Springs, Boynton Beach, Bradenton, Cape Coral,  Clearwater, Coral Gables, Coral Springs,  Daytona Beach, Deerfield Beach, DeLand, Delray Beach ,Fort Lauderdale, Fort Myers, Fort Pierce, Fort Walton Beach, Gainesville, Haines City, Hallandale Beach, Hialeah, Hollywood, Homestead, Immokalee, Jacksonville,  Key West, Kissimmee, Lakeland,  Largo, Melbourne, Merritt Island, Miami, Miami Beach,  Naples,  New Smyrna Beach, Ocala, Orlando, Ormond Beach, Palm Bay, Panama City, Pensacola,  Plant City, Pompano Beach, Port Charlotte, Port Saint Lucie, St Cloud, St. Petersburg, Sarasota, Spring Hill, Starke, Tallahassee, Tampa, Tarpon Springs, Titusville, Venice, Vero Beach, West Palm Beach, Pensacola, Winter Haven, and Winter Park are filing lawsuits on behalf of Florida women suffering from the various Prolene synthetic mesh devices.

Hundreds of  Florida women have been implanted with various vaginal mesh devices. These include mesh for uterine prolapse, bladder prolapse, bowel prolapse and urinary incontinence. We have special concerns for our seniors.  Calls coming in from children and grandchildren concerned for their loved ones who are suffering and withdrawing.  They are alone and cannot actively help themselves. We have heard from children with mom's in their eighties with a mesh and we wonder what doctor would put such a product in a woman of this age.

The mesh can be life threatening for our Florida senior women. Infection and bladder or bowel perforation can lead to very severe medical complications. Infection in a senior population can result in the body becoming septic which can be fatal. Our senior woman with these mesh devices are suffering and must have justice. Naby of them have given up and cannot get the correct medical care. We are here to help.

If you have a grndmother, mother, or wife with a mesh who is suffering you must reach out an help. Call the Vaginal Mesh Helpline and we will help you locate a doctor. many seniors come from an era where sueing is unheard of. It is up to you to reach out on theor behalf and encourage them. All wome of all ages must come forward to stand up against these manufacturers.

We are here to help. Call the Vaginal  Mesh Helpline for help with complications from these vaginal mesh and baldder sling implants.

C.R. Bard's products include:

•       Pelvitex
•       Pelvisoft
•       Pelvilace or Pelvicol
•       Utrtex
•       Uretex TO
•       Uretex TOO2
•       Uretex TOO3

Gynecare/Ethicon/Johnson & Johnson products include:

•    Prosima
•    TVT Exact
•    TVT Abbrevo
•    TVT Retropubic System
•    TVT
•    TVT Obturator
•    TVT Secur
•    Gynemesh PS
•    Prolift
•    Prolift+M

AMS's products include:

        AMS MiniArc Precise Single-Incision Sling
        AMS MiniArc Single Incision Sling
        AMS Monarc Subfascial Hammock
        AMS In-Fast Ultra Transvaginal Sling
        AMS BioArc
        AMS Sparc Self-Fixating Sling System
        AMS Elevate
        AMS Perigree
        AMS Apogee

Boston Scientific products include:

        Boston Scientific Arise
        Boston Scientific Pinnacle
        Boston Scientific Advantage Fit
        Boston Scientific Lynx
        Boston Scientific Obtryx
        Boston Scientific Prefyx PPS
        Boston Scientific Solyx

Tyco Covidian (which manufacturers the Tyco Covidian Duo and Mentor ObTape)

The mesh lawyers are filing lawsuits for Florida. Florida Statue of limitations is still within a timely period to file. However, do not wait as

Tennessee, Kentucky and Louisiana women are past the statue to file already. This is not sometyhing tp put off till later.

The Vaginal Mesh Helpline and vaginal mesh lawyers warn that is is imperative to file your vaginal mesh lawsuit right away. There is a statute of limitations in every state and you do not want to miss out. You must see a physician immediately to secure your legal rights in the vaginal mesh lawsuits. But, there is no need to wait. If you miss your state's filing deadline you can miss out. The mesh has caused you pain and suffering. Do not miss out like this poor Georgia woman.

A federal judge has just dismissed a lawsuit filed by a Georgia woman after it was determined her lawsuit against a vaginal mesh manufacturer was filed outside of the two-year statute of limitations in that state. The woman filed her lawsuit in July 2011. She had the Boston Scientific Pinnacle Pelvic Floor System implanted along with a Prefyx Pre-Pubic Sling in 2008 after a hysterectomy for pelvic reconstruction surgery.

By March 2009, she experienced transvaginal mesh complications, including having the mesh erode into her vagina. She experienced stress urinary incontinence and chronic pain. Her case was to be heard individually, not part of the larger classes that are consolidating. She alleged Boston Scientific was negligent in making a defective mesh product.

Unfortunately, her lawsuit was dismissed by Judge Thomas W. Thrash in the federal court for the Northern District of Georgia. Her deadline to file was March 2011, two years after she first experienced a problem. The judge decided there were not extenuating circumstances that would justify extending the deadline for this woman. The decision in this case does not affect the other cases being consolidated in Multidistrict Litigation (somewhat similar to a class action), but this woman has exhausted her options.

The Vaginal Mesh Helpline is very concerned  about this poor woman. In some instances the cases can be moved to the state of the manufacturer but, that is always a long shot. The  Prolene vaginal  mesh causes very severe complications including:

• Erosion into the vagina, bowel of bladder
• Relentless infections
• Razor blade like pain 
• An inability to walk, work and take part in the activities you once loved to do.
• Inability to have intimate relations
• Lower back pain
• Bowel discomfort
• neurological impingement
• Increased urinary or bowel incontinence or
• Inabilty to void easily and need for self catherization
• Patch bleeding

The Vaginal Mesh Has Caused Life Changing Events :

• Women have lost their jobs
• Women have lost their marriages, fiances and male companions.
• Women have suffered severe psycholgical stress and in some cases thoughts of suicide.
• You no longer trust the Doctor you have relied on and in many cases Doctors in general.
• Many women tell us they no longer trust anyone.
• Mass solicitation by lawyers, email blasts and text messages have made you feel like a target.
• Many Grandmas have lost the ability to enjoy their  grandchildren like they once did.
• Many senior women in their 80's feel like their life is over. Many younger women are feeling like this as well.
• Now there is an Inability to partake of things you once enjoyed and considered a part of your daily life.

Many husbands are sueing along with the spouse for loss of consortorium. Marriages have been effected and whole families are suffering. You must take a stand and protect not only your rights, but also all women. Doctors are still implanting the vaginal mesh today after all the warnings and posted side effects. We must send a message the manufacturers who put profits over people and see women as a profict center.

When Does the Time Limit Start To Run?

In some defective product cases, determining when the time limit starts to run is fairly straightforward. For example, if your finger is sliced off by a defective electric carving knife, and in your state the statute of limitations for product liability claims is two years, you must bring your lawsuit within two years from the day you lost your finger.

But some types of injuries are more difficult to detect, and may not be discovered until months or even years after the injury actually occurs. For example, if your lungs are injured by inhaling fumes from a defective chemical product you used, you may not discover your injury until you develop lung inflammation many months or even years later. In such cases, the issue of when exactly the statute of limitations (or time limit) began to run may be crucially important to whether you can still file a defective product claim or if you've missed the deadline.In some states, the statute of limitations begins to run when the injury actually occurs. This can have harsh consequences if the injured person doesn't discover the injury until after the statute of limitations has already expired.
When the Injury is Discovered

In many states, the statute of limitations begins to run only when the injured person discovers (or should have discovered) the injury. For example, let's say you were injured by inhaling fumes from a defective chemical product and you discovered your injury years later when your doctor diagnosed you with lung damage. In a state with an injury-discovery rule, the time limit on your defective product claim would begin to run on the date of your lung damage diagnosis (that is, when you discovered your injury), not when you inhaled the noxious fumes (in other words, when the injury actually occurred).

In these states the statute of limitation can begin to run when the injured person should have discovered the injury. The "should have discovered" part of this rule means that the deadline may start to run even though you do not actually know you have been injured. For example, in the lung injury hypothetical mentioned above, let's say you develop a terrible cough but delay going to a doctor for several months. A court might decide that the statute of limitations started to run when you developed the cough, as opposed to when you finally went to the doctor, because you should have discovered your injury when you first developed the mesh erosion

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The Vaginal Mesh Helpline continues to report on the news that effects women with vaginal mesh complications. The new FDA tracking system comes a little late for the over 300,000 women implanted with vaginal mesh devices and suffering. However, there is hope. This sends a message that our voices have been heard. By filing vaginal mesh lawsuits and standing up for justice you protect yourself and all women from becoming targets of manufacturers who put profits over people.

FDA’s Propose Tracking System Could Reduce Vaginal Mesh Complications
Tracy Ray

The FDA has proposed a new regulation that would require all new medical devices to carry a unique device identifier (UDI). The UDI would be a code of letters and numbers. Such a code would make it much easier to track devices, which in turn would make it much easier to report complications with a particular model or to find out about such problems.

According to the FDA, “A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety.”

For example, if such a tracking system were in place, a doctor who had a patient with stress urinary incontinence (SUI) or pelvic organ prolapse (POP) and wanted to implant a vaginal mesh device could look up the different models by the UDI and immediately see what transvaginal mesh complications, if any, had been reported with each specific model. Likewise, in the event of a recall, a UDI would make the process much more efficient: the company or the FDA would simply announce that the model carrying a particular UDI number was being recalled.

The FDA’s proposal was a response to legislation passed by Congress in 2007 that directed the FDA to develop regulations establishing a unique device identification system for medical devices.
Many women have suffered transvaginal mesh complications

Such a system might enable future patients to avoid problems resulting from transvaginal mesh. Many women have suffered such complications, including pain, infections, mesh erosion, protrusion, vaginal scarring, dyspareunia, and perforation of the bowels, bladder, or blood vessels. Many of these devices were approved under the FDA’s controversial 510(k) approval process, which allows products to be approved without first undergoing clinical trials to prove they are safe.

If the physicians treating these women had been able to easily look up the type of vaginal mesh device they were considering implanting, and immediately see reports of problems associated with the device, they would have been able to weight the risks and make an informed decision about whether to implant that particular device.
Vaginal mesh MDL consolidated lawsuits

Many women who have suffered complications have filed vaginal mesh lawsuits in order to get compensation for their pain, suffering, and reduced quality of life. Most of these lawsuits charge that the manufacturers of these devices did not test them for safety before putting the on the market and failed to warn the public of the devices’ risks. A number of federal lawsuits have been consolidated in a vaginal mesh MDL in West Virginia.

For help call the Vaginal Mesh Helpline and Vaginal Mesh Support Group today, Let us help you find and vaginal mesh lawyer and doctor.

The Vaginal Mesh Helpline is continuing to report on new news to give hope to women with vaginal mesh complications. Vaginal mesh lawsuits are being filed thru-out the country for women. You must retain an appropriate lawyer for a mesh implant lawsuit as quickly as possible. You must also get medical attention. Check our state pages. New Doctors are being added on a regular basis.

Vaginal Mesh Lawsuits Continue

A national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a woman who allegedly experienced painful and disfiguring symptoms after being implanted with the Monarc Subfascial Hammock and Apogee System with Intepro. The lawsuit alleges that the transvaginal mesh products caused injuries, and holds the Defendants, American Medical Systems, Inc., responsible for failing to warn about the dangers associated with the device. The suit was filed on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-03173). There, it is among the many cases filed into the multidistrict litigation known as the In Re: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2325).

According to the Complaint, the Plaintiff was implanted with the Monarc Subfascial Hammock and Apogee System with Intepro in July 2005. The mesh was used to treat her pelvic organ prolapse and stress urinary incontinence, the two uses for which the devices were approved, marketed and sold. The lawsuit alleges that the devices caused the Plaintiff to suffer significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and the loss of her bodily organ system.

The lawsuit also alleges that the Defendants failed to warn about the risks associated with transvaginal mesh. According to the complaint, the mesh is not inert and reacts with the body. This, the suit states, can lead to a host of adverse health consequences including:

        Vaginal erosion (also known as exposure, extrusion or protrusion)
        Infection
        Organ perforation
        Chronic pain and/or abscess

The vaginal mesh  lawsuit holds the Defendants responsible for exposing women to these risks, especially since they were allegedly aware of such complications.

The U.S. Food and Drug Administration (FDA) has ordered American Medical Systems and 32 other manufacturers to study the impact of transvaginal mesh on organ damage and other health issues. Last July, the agency said that the mesh has no clear advantage over non-mesh methods for treating pelvic organ prolapse even though it may present additional risks. The FDA went on to say that most cases of POP can be successfully treated without transvaginal mesh.

You must stand up for justice and protect other women. As a group we can send a message. For help and support call The Vaginal Mesh Helpline today.
 

The  Mesh Helpline still hears from women who are having complications and just realized it is from the mesh. Most of these women have seen a lawyer ad on T.V which alerts them to realize they are not alone and that their doctors are giving them the run around. Other women are disenchanted with the T.V ad lawyer they hired or a local lawyer who has sent the case to another lawyer someplace else. There are some basic vaginal mesh guidelines:

Vaginal mesh complications include pain, leakage or incontinence or the bladder or bowel, parch bleeding, infection, pain during sexual intercourse, lower back pain, pain on one side of the body, abdominal pain and difficulty standing for long periods

You are not alone. Close to 400,000 women have vaginal mesh or bladder sling implants

A vaginal mesh comes in many varieties, made by many different manufufacturers. They can be called a sling, a transvaginal mesh, a TVT sling, a bladder sling, a surgical mesh, a vaginal patch and it is still a mesh and part of the Vaginal mesh lawsuts currently underway.

For the men: Sexual intercourse is indeed painful for your wife. She is not lying or making it up. But, with the right doctor there is hope of resuming a normal life. Many men are sueing with their spouse. A California husband just got an award  for $500,000 for loss of intimacy in the relationship.

The mesh can be removed and your body repaired with sutures or another means. A urogynecologist is usually a mesh specialist although a GYN surgeon or urologist can remove the mesh. You must ask the doctors office if the doctor has ever removed a mesh and you must get a straight answer.

Physical therapy will not help the mesh and may be dangerous by pushing it into an organ. This is not a good idea. Estrogen creme will not necessarily help either. You must look into mesh removal.

The vaginal mesh lawsuits are currently underway. It is important to retain a lawyer, and the right lawyer, asap. Statutes of limitations are running out in some states. You will have to go to a doctor to get a statement that you have a mesh problem. If you rely on old medical records it may become harder to prove your case. The best situation is to have a statement in the record that mesh removal or alteration is needed and that you have a mesh issue.

Additional Important Information

Surgical mesh was designed in the 1950s to correct abdominal hernias. The woven material is placed below the skin to patch the abdominal hole and block intestines and other tissues from protruding through the abdominal wall.

Surgical mesh can be made of biological materials or synthetic materials like polypropylene, polytetrafluoroethylene, polyester fibers or stainless steel. The size, shape, thickness and flexibility vary based on the surgeon’s needs. Often, the mesh comes in a prepackaged kit with the necessary tools, to make the procedure easier.

The Food and Drug Administration (FDA) reports that hundreds of thousands of hernia repair surgeries are performed each year — with and without surgical mesh — and patients typically recover quickly. However, the FDA has received reports of adverse reactions to the mesh, adhesions (where the loops of the intestines attach to each other or the mesh), and injury to organs, nerves or blood vessels.

Overall, the treatment of hernias with surgical mesh is considered successful, so doctors wanted to use it in other parts of the body that required additional support. In the 1970s, they began inserting surgical mesh abdominally to treat pelvic organ prolapse (POP). In 1996, the FDA approved the first mesh product for treatment of stress urinary incontinence (SUI). The first mesh product for treatment of prolapse was approved in 2002.

Instead of inserting the mesh through abdominal incisions, however, surgeons have recently embraced the idea of implanting the mesh transvaginally (through the vagina). This choice has been disastrous for thousands of women, who have suffered severe complications such as organ perforation and erosion of the mesh. Even revision surgeries cannot always remove the mesh or correct the internal trauma.
Transvaginal Mesh and Pelvic Organ Prolapse

To treat pelvic organ prolapse, surgical mesh can be implanted at the time of a hysterectomy or as a separate surgery. When surgical mesh is inserted through the vagina, it is referred to as transvaginal mesh.

Pelvic organ prolapse is a condition in which the bladder, top of the vagina, uterus, rectum or bowel has descended from its normal position. The condition is thought to be the result of weakened pelvic muscles, usually from pregnancy and childbirth. Of the 300,000 surgical procedures done to correct prolapse in 2010, 100,000 used mesh and 75,000 of those were completed transvaginally.

When transvaginal mesh is used to repair prolapse, the surgeon uses the woven material to create a hammock-like structure under the drooping organ or organs. Once in place, the mesh is anchored to muscles or ligaments by sutures or other devices. Over time, the patient’s tissues grow and fill in the pores of the mesh to keep it stable. The hammock, in turn, maintains the correct position of the affected organ.
To treat prolapse, transvaginal mesh is most commonly placed in these locations:

    The anterior vaginal wall to correct a bladder prolapse.
    The posterior vaginal wall to correct a rectal prolapse.
    The top of the vagina to correct a uterine prolapse.

The most common and serious of the complications for patients is the erosion, or extrusion, of the mesh into nearby organs. This can lead to bleeding, pain during sexual intercourse and urinary problems. Revision surgeries may not fix the problem. And if the patient’s tissues have already grown through the mesh, removal may be impossible.
Transvaginal Mesh and Stress Urinary Incontinence

Surgical mesh can also be used to create a bladder sling that is positioned under the urethra and bladder neck and anchored on the sides. The bladder sling is designed to treat stress urinary incontinence (SUI), which occurs when the bladder is stressed by an everyday activity, such as sneezing or laughing, and subsequently leaks urine. The sling keeps the urethra and bladder neck closed during normal activities, stopping the leakage. In 2010, nearly 260,000 surgeries were performed to correct SUI. Of those, 80 percent were performed using surgical mesh implanted transvaginally.

When a bladder sling is inserted through the vagina, it is known as transvaginal mesh. Typically, small abdominal incisions are also used.
Among the most popular bladder slings:

    Tension-free vaginal tape (TVT): A polypropylene mesh tape is used under the urethra and is held in place by the patient’s body.
    Transobturator tape (TOT): Less invasive than TVT, because there is no need to use a large needle when inserting it.
    Mini-sling: Eliminates the need for abdominal incisions. A metallic inserter and a vaginal incision are used to place the mesh tape.

As with prolapse surgery, there have been widespread reports of serious complications after bladder sling surgery using transvaginal mesh. Many patients have prolonged difficulty urinating or they incur new symptoms of incontinence, specifically urgency. In addition, they run the risk of the slings eroding into nearby structures, organ perforation, infection at the surgery site and internal bleeding.
Transvaginal Mesh and the FDA

Between 2005 and 2007, the FDA received 1,000 reports of complications and injuries related to transvaginal mesh surgeries, including death. The FDA decided to begin studying the medical device in October 2008. The FDA reported that between 2008 and 2010, there were nearly 2,900 reports of injuries caused by transvaginal mesh.

By July 2011, the federal agency concluded in a public safety update that complications with the use of transvaginal mesh for treatment of prolapse are not rare and that mesh repairs are no more effective than non-mesh repairs for treating prolapse.

The FDA took its concern a step further in January 2012, stating that after studying years of scientific data and recommendations from the September 2011 Obstetrics-Gynecology Devices Panel meeting, it was considering reclassifying transvaginal mesh as a high-risk device. If that happens, mesh devices will be subjected to more rigorous testing, including clinical trials with humans.

In that same update, the FDA requested safety data from all surgical mesh manufacturers and ordered post-market studies from seven manufacturers of single-incision mini-slings for SUI and 33 manufacturers of surgical mesh for prolapse.

If you need help with your vaginal mesh call the Vaginal Mesh Helpline today.