Hernia Mesh Recall

hernia mesh recallHernia Mesh Recall – Have You Been Harmed?

Those who have been implanted with surgical mesh should be informed that there has been a Hernia Mesh Recall. There has also been a recall on certain Transvaginal mesh implants used to treat the conditions Pelvic Organ Prolapse, (POP) and Stress Urinary Incontinence (SUI). Surgical mesh is used to repair hernias, and transvaginal mesh is surgically implanted through the vagina to support weakened pelvic muscles in both POP and SUI. These medical ailments can be troublesome, but if corrected with the use of pelvic mesh, problems far worse than the initial conditions can arise. For this reason, there has been a Hernia Mesh Recall. Anyone who feels that their quality of life has been lessened after being implanted with mesh may be eligible to file a Mesh Lawsuit.

Before the Hernia Mesh Recall

As women age, their pelvic muscles and organs sometimes become weak, resulting in the lowering of the rectum, uterus and bladder into the vagina. The implantation of surgical mesh was intended to ease the suffering of these women, but sadly not all implants are safe. Some of the designs and procedural techniques that were used resulted in grave complications such as organ perforation and tissue infection.

Rising Figures for Hernia Mesh Recalls

Over 275,000 women underwent corrective surgery for either POP or SUI last year alone. According to the Food and Drug Administration (FDA), there is a procedure that inserts the pelvic mesh inside the abdomen which results in fewer complications. However, since this procedure is not well known, more women have undergone the more common insertion technique, which led to complications and eventually resulted in the hernia mesh recall.

There are thousands of reports from women all over the United States complaining about the negative effects of the pelvic mesh operation. There are at least 23,000 lawsuits that are pending in the U.S. District Courts and State Courts regarding mesh injury.

From 2008 to 2010 the FDA obtained 1,500 reports of complications from various women who went under the knife for the vaginal prolapse surgery with mesh. The agency is now looking into pelvic mesh operations for incontinence and is trying to pin down the possible side effects that were sustained, even though this type of procedure requires less mesh usage.

Hernia Mesh Recall Warns of Possible Death Risk

Due to the rising reports of pelvic mesh complications, the FDA has released a statement asking for a hernia mesh recall throughout the country. The FDA stated that there is a possibility of death if the infection caused by the pelvic mesh is not treated right away. They also advised women who had been implanted with mesh to seek medical attention immediately if they start to experience the following symptoms: persistent abdominal pain, device failure, high fever, and softness of the area of the implantation site.

A top device scientist of the agency said that although certain devices have been recalled, there will be no government withdrawal of the product because there are still patients that can get positive effects from it. Many people are outraged and are trying to call for a ban on all mesh implants because they cause far more harm than good.

Get Help With A Surgical Mesh Lawsuit

Contact us today if you’ve suffered complications from Hernia or Transvaginal Mesh implants. Pretrial litigation has begun and there may only be a limited time to claim compensation for the conditions you’ve suffered. Do not let the manufacturers get away with producing faulty devices which have caused life altering conditions in consumers. Complete the form on this page today to speak with a legal expert about your options in response to the Hernia Mesh Recall.

 

Transvaginal Mesh Lawsuits

transvaginal mesh lawsuitsTransvaginal Mesh Lawsuits: Get Compensated Today

The need to file Transvaginal Mesh Lawsuits has become widespread throughout the country and the manufacturers are opting to settle. When everyday life becomes a nightmare due to a procedure your doctor said was simple, it is time to seek legal counsel and begin a vaginal mesh lawsuit. 

Transvaginal mesh is a product designed to be implanted to prevent leakage of urine in patients with weak muscles of the pelvic region. Transvaginal mesh was first introduced in the US in the 1990s. The devices became popular because millions of women suffer from weakened pelvic muscles that cause urine leakage and other more severe medical conditions. Transvaginal mesh was thought to be the cure for many women’s ailments; unfortunately, it has turned out to be a more severe problem than the one it was intended to control.

FDA Disregards Formal Review for Transvaginal Mesh Implants

The US FDA (Food and Drug Administration) approved the Transvaginal mesh devices in 2005 using a system of Transvaginal Mesh Lawsuits fast-tracking products known as the 510 (k). This process disregards the formal review process of the safety of a product. This has allowed several controversial devices and products to be introduced onto the US market and Transvaginal mesh implants are a prime example.

Since their initial approval, over a thousand reports have been filed against the manufacturers regarding Transvaginal mesh implants. The FDA also confirmed that companies alerted them of the side effects caused by their devices during the three years after the approval of the device. In October 2008, the FDA was forced to issue an alert regarding these complications.

In July 2013, a public notice was issued by the FDA regarding Transvaginal mesh and the public was advised to look for alternatives to the Transvaginal device. Sadly, this came too late for some people as the damage had already been done.

Fortunately, though, you can get adequately compensated if you choose a reputable company with personal injury lawyers to represent you. If you qualify, our team of experts ensures that you receive the maximum compensation for your troubles. The device should have made women’s lives better, but many have experienced life threatening consequences.

Donna Cisson vs. Bard Avaulta – Transvaginal Mesh Lawsuits

In 2010, Donna Cisson was awarded $2 million in her case against Bard Avaulta. The company in mention was responsible for manufacturing the Transvaginal mesh that she used to manage her weak pelvic muscle condition. This was a personal injury lawsuit filed in West Virginia’s US District Court.

In her case against Bard, she described how the Transvaginal mesh manufactured by the company, caused her severe pain and bleeding. She went for surgery to have the device implanted and started experiencing severe side effects soon after.

The jury found that Bard Inc. indeed failed to warn the public of the side effects associated with implanting Transvaginal mesh and knowing the risk involved in their product, they continued production and distribution anyway. As a consequence, Donna Cisson was awarded a total lump sum of $2 million with punitive damages of $ 1,750,000 and a compensation of $250,000.

This Multidistrict litigation was consolidated in October 2010.

Wanda Queen vs. Bard Avaulta – Transvaginal Mesh Lawsuits

Wanda Queen took her complaint to court after she had to endure additional surgeries because of complications with the Transvaginal device. She was compensated August 21st in the Federal court of West Virginia. The settlement terms are yet to be released.

In her statement in court, she described how the Transvaginal mesh implant began to cause complications and injury, forcing her to go through six more corrective surgeries. She explained how the device seriously decreased her quality of living.

Her settlement amount from the company has remained private to date. This was the second trial against Bard Avaulta and their defective Transvaginal mesh after Donna Cisson.

There are several pending Transvaginal mesh lawsuits against Bard’s implants. Failure of the company to issue warnings regarding potential dangerous side effects prior to the release of their product has put the company in a Multidistrict litigation.

Transvaginal Mesh Lawsuits Against Numerous Manufacturers

Bard Inc. is not the only manufacturer with a case to answer to. Boston Scientific Corp., Johnson & Johnson, American Medical Systems Inc., Mentor Corp., Endo Health Solutions Inc., Cook Medical and Coloplast are also involved in pending Transvaginal mesh lawsuits.

The main problem with these implants is that they tend to shrink over time leading to a variety of health problems in the device recipient. Transvaginal mesh usually requires surgery for implantation.

The Johnson & Johnson Transvaginal Mesh Lawsuits

Johnson & Johnson has a subsidiary company known as Ethicon that manufactures Transvaginal mesh. Ethicon, according to documentation in courts in West Virginia is in a legal battle with affected plaintiffs. Their transvaginal mesh is also responsible for these plaintiffs filing a lawsuit against them. The next conference informing the public on the status of the pretrial proceedings was set for September the 19th, 2013.

Consolidation of the Transvaginal Mesh Lawsuits

Consolidation of the Multidistrict litigation was done before the District Judge Joseph Goodwin for exchanges of pretrial information. This took place in Charleston, SC. Court dockets confirm that October will arrive with two trials against Bard Inc. commencing then.

MDLs or Multidistrict Litigations are proceedings that enable cases involving product liabilities to be heard individually without interfering with civil action taking place in different state districts regarding factual questions on the product. MDLs help in delivering fair rulings depending on the degree of injury on individual plaintiffs. This also eventually reduces pretrial rulings from different judges that might eventually conflict.

If you have used any Bard Inc., product listed below and you are experiencing side effects such as bleeding, pain during urination and sexual intercourse, erosion of organs around the implant and other complications, you have a right to seek legal help. The products are sold under the following brand names:

  • Avaulta™ Plus Biosythetic Support System
  • Avaulta™ Solo Synthetic Support System
  • Faslata® Allograft
  • Pelvisoft® Biomesh
  • Pelvicol® Tissue

Separate lawsuits in different states affect various manufacturers. The plaintiffs exceed the 20,000 mark. Transvaginal mesh lawsuits will also be heard on different set dates for the Middle District of Georgia and Atlanta, and New Jersey Courts.

Do I Qualify to Begin A Lawsuit?

Transvaginal Mesh Lawsuit

Transvaginal Mesh Lawsuit: A Class Action

transvaginal mesh lawsuitTransvaginal mesh lawsuits are continuing to line up in court against the manufacturers of these defective devices. In a continued effort for justice, lawyers across the US are striving to help any woman who has been a victim of a Transvaginal mesh implant.

Transvaginal mesh implants caused numerous complications in patients suffering from stress incontinence and pelvic organ prolapse disorders. These conditions developed due to the weakening of pelvic muscles over time. Women are now filing Transvaginal mesh lawsuits to address issues of the implants inability to manage these disorders.

History of the Transvaginal Mesh Lawsuit

In 2005, the medical manufacturer Bard Avaulta, was approved to produce and market Transvaginal mesh implants. The Food and Drug Administration is the organization responsible for approving new medical devices and drugs before they are released onto the market. There are certain procedures followed by the FDA in order to approve or deny manufacturing and production. New devices should undergo rigorous testing prior to release; however, there is a system of approval that does not require products to be formally reviewed for safety. This system is called the 510 (k) by the FDA. Unfortunately, it has caused many controversies in the US because of faulty products being introduced to the public without thorough testing.

Companies opt to follow the fast track approval system provided by the administration in order to start selling their products to the public as soon as possible after innovation. However, a requirement is that they must alert the public of any potential damages or side effects the product can cause before any sales are done. This step protects the public from manufacturers out to sell faulty products for their own gain.

Since companies usually preform their own preliminary tests, they are usually aware of the potential harm products such as Transvaginal mesh implants can cause to a patient. Thus, they have no excuse if they sell potentially harmful devices without prior notice to the public. If they do so, the public can call for mass action through a lawsuit. This mass action is also called a class action lawsuit. It requires several plaintiffs to come forward and lodge their complaints with the courts so that judges can unanimously agree on a uniform way to deal with the litigation.

However, cases are heard on an individual basis and the compensation the plaintiff receives is dependent upon the injuries sustained. It is therefore important to contact experienced attorneys to represent you in order to get maximum compensation.

Unfortunately, Bard Avaulta, among several other companies such as Johnson & Johnson’s subsidiary, Ethicon, went ahead and distributed the Transvaginal mesh device for sale immediately after the FDA approval.

Later in 2008 and recently in 2011, the FDA issued an alert to the public over the harmful nature of the device. The governing body asked patients to consider other options before deciding on the transvaginal mesh implants. This led to the beginning of transvaginal mesh lawsuits.

What the Transvaginal Mesh Lawsuit Can Do For You

A Transvaginal mesh lawsuit can change your life for the better. You will soon be able to afford and receive quality health care if you qualify to file. Because you were unknowingly put at risk, you deserve access to proper health care to manage side effects of the implants and resources to enable you to find an alternative to the faulty solution offered by the manufacturing companies.

The only way to begin the road to financial recovery is to get an attorney who is experienced in litigating against defective medical device manufacturers adequately represent you. Such an attorney will convince the court why you should receive full compensation for the damage, pain, tears and follow up surgeries you might have gone through after the first implant of this device.

Once the court is convinced that you indeed require compensation, you will be free to seek out any professional health care provider to manage your condition and if possible, reverse the damage caused by your Transvaginal mesh device.

Hopefully with the help of the lawsuit, you will have the means necessary to have the procedures performed that would allow you to return to a healthy, productive life. Complications from the device should cease upon removal and your initial ailments can be treated with alternate therapy.

The Public’s Role in The Transvaginal Mesh Lawsuit

If you feel that your condition may have been worsened by implantation with a Transvaginal mesh device you should seek legal counsel to learn about your options. In order for a class action lawsuit to be classified as one, several plaintiffs should be present as evidence of the faulty nature of the device.

The court grants justice in accordance with the evidence presented. It is therefore important for you, the plaintiff to come forward and see if you qualify to represent the injured and affected people throughout the country. You will also get the chance to have a wrong done to you by these companies corrected in court.

By so doing, you also help to control any future products from being released prematurely without adequate testing or warnings issued to the public. Making the risks of defective products known to the public can improve millions of lives.

How Soon is Your Action Required in The Transvaginal Mesh Lawsuit?

Because the Transvaginal mesh lawsuits are consolidated in Georgia and West Virginia, pretrial discussions are possible. In October, trials against companies that manufacture Transvaginal mesh will be lining up. It is important that you be counted among plaintiffs so that your case can be heard early and you can manage your health as soon as possible without letting the situation get out of hand. Act before it is too late to save your health. The earlier you do so, the better your outcome may be.

The Transvaginal Mesh Lawsuit: Why Choose Us?

We are a company with reputed product injury attorneys who are qualified to get you maximum compensation for damages and losses caused by Transvaginal mesh implants. The goal of our attorneys is to get you a fair amount of compensation. Do not gamble with your health, contact us today and become part of the group of plaintiffs who have been adequately compensated by the responsible companies. Call us today or complete the form on this page to begin the process of filing your Transvaginal mesh lawsuit .

 

Transvaginal Mesh Complications

In Depth Report on Transvaginal Mesh Complications

Transvaginal Mesh ComplicationsTransvaginal mesh complications have become common among those implanted with the defective devices. These complications occur because the surgical mesh that comprises the device is flawed, and consumers were unaware of the potential risk of bodily harm. This mesh is usually a woven fabric used to support the organs in the pelvic region such as the bowel, urethra, bladder, rectum, uterus and the top of the vagina.

Insertion of Transvaginal mesh is done through a surgery which attaches it to the weak muscles that need support. Unfortunately, removal of the mesh after insertion can become almost impossible because this device sometimes fuses with the surrounding tissues or organs. When artificial devices such as surgical mesh grow into the tissues, corrective surgery may no longer be an option. The possibility for surgical reversal is dependent upon how long the condition has been left to progress.

Have You Experienced Mesh Side Effects?

Those that have received the implant should seek medical attention as soon as they notice any symptoms that are out of the ordinary for the best chance of reversing the complications. The initial implant procedure is risky and you need to be fully aware of the risks involved. Although there have been hundreds of reports of serious Transvaginal mesh complications, these devices remain viable as surgery options. If you are considering such a surgery, you will want to familiarize yourself with the conditions you could develop at a later date.

Since removal of the Transvaginal mesh implant can become nearly impossible once it has fused with other organs, surgeons are challenged with implementing new techniques to ease pain and suffering. For the patient, life may become unbearable when pain begins to define common occurrences like sitting down, walking and sexual intercourse. It is unfortunate that many patients who underwent surgery with the implant are experiencing problems today. Had the manufacturers taken the preliminary precautions and preformed the proper testing with these products, the consumers would have been aware of the risks. Many would have opted for alternative treatment.

Symptoms of Transvaginal Mesh Complications

Complications arising from the Transvaginal mesh implant have led to lawsuits in courts all over the country. If you are experiencing the following symptoms, you may be able to receive compensation from the manufacturer for the pain this product has caused.

These symptoms are affecting millions of women who have been implanted with Transvaginal mesh to manage stress urinary incontinence (SUI) and pelvic organ prolapse (POP) associated disorders.

· Pain in and around the pelvic region and groin whenever simple tasks are performed such as walking, sitting or having sexual intercourse.

· Infection around the region of the mesh implant

· Urinary Tract Complications and problems

· Bleeding

· Damage around the mesh implant area

· Damage to other body organs near the region of mesh implant

· Protrusion and/or erosion of the mesh to the soft tissues around the implant area

· Failure of the mesh to correct the initial problem such as SUI or POP

It has been reported that there might be other complications; if you notice anything out of the ordinary it is advisable to seek medical attention at once.

Steps to Take When Experiencing Transvaginal Mesh Complications

If you have been affected, you may be able to seek compensation for Transvaginal mesh complications. How do you know if you qualify? The only way to find out is by contacting our product injury attorneys for an evaluation of your case.

The courts have allowed plaintiffs to register for an evaluation of how deeply affected they are by the mesh implants. We have qualified injury attorneys that will ensure that you are fully compensated for damages arising from the Transvaginal mesh implants. Contact a qualified physician to find out whether you are experiencing symptoms of Transvaginal mesh complications.

Transvaginal Mesh Complications Today

The Food and Drug Administration approved the use of these vaginal implants in 2005. Unfortunately because of the system used to approve the device, important testing and re-testing was never done to guarantee 100% safety of the device. There was a lack of oversight of the FDA approval system. Therefore, it became the responsibility of the manufacturing companies to bring any safety issues to light in order for the patient to decide whether to risk using it or not.

Of course, companies do their own research and have an idea of whether what they sell is fit for human use. According to the law of manufacture, it becomes a fraudulent action when a company sells devices such as the transvaginal mesh, to the public, when the company knows that the devices are faulty. The companies responsible for selling faulty transvaginal mesh to the public have broken the law and should face the consequences of their actions.

The only way to make these companies pay would be to file a lawsuit. This will help them reassess their devices in the future before selling them to the public and issue timely alerts to the public before distributing their products.

Studies That Warn about Transvaginal Mesh Complications

In a recent study reported by the New England Journal of Medicine, the spotlight was cast on the troubling side effects that come with implanting Transvaginal mesh devices into the pelvic muscles. It compared this procedure to a procedure known as colporrharpy whereby connective tissues of the body are stitched together to strengthen that particular muscle.

The study brought to light the fact that women who underwent this procedure increased the chances of bladder perforation seven times over. The study also stated that such women were twice as likely to experience a total loss of bladder control.

New Developments of the Mesh Lawsuit

Transvaginal mesh manufacturers are facing thousands of federal lawsuits. These lawsuits were earlier consolidated into a Multidistrict Litigation by Chief Judge Joseph R. Goodwin of the US District Court of the Southern District of the State of West Virginia.

So far, four separate cases against various Transvaginal mesh manufacturing companies have been settled with the highest settlement being $11 million.

Any victims of Transvaginal mesh complications should be informed that it is not too late to file a claim seeking compensation. However, you need to know that trial dates are now being set. Call today or complete the form on this page to get the process of filing your lawsuit started.

As of August 15, 2013, 25,910 plaintiffs have pending cases regarding transvaginal mesh complications.

 

Transvaginal Surgical Mesh

Transvaginal Surgical Mesh Implants and Associated Lawsuits

Transvaginal surgical mesh is a device inserted in the pelvic region to support weakened muscles. This mesh is a material that is woven from cloth. It was first intended for correcting hernias but it began to be used to manage stress urinary incontinence (SUI) and pelvic organ prolapse (POP) as well. However, Transvaginal surgical mesh implants have caused more harm than good since they were approved in 2005 by the FDA. They were intended to prevent organs near the vagina from protrusion but instead went on to create more severe problems worse than the initial condition.

The FDA is also to blame for allowing such devices onto the market. The manufacturing companies carry the bigger blame though because they continue to break the law by selling people faulty devices without their knowledge. The companies put their economic interest first and neglected the safety and health of consumers. Any devices, products or services delivered to consumers with associated risks should be delivered with prior notice of the hazards. This option is made available in order to allow the consumer to choose whether to go ahead and make a purchase or choose an alternate healthcare option.

Transvaginal Surgical Mesh Types

There are three main kinds of Transvaginal surgical meshes.

· Mini-sling

· Tension-free vaginal tape sling

· Trans-obturator tape sling

The mini sling is a kind of transvaginal surgical mesh that avoids multiple incisions during insertion thus quickening the healing time. This also reduces other risks associated with surgery such as damage to surrounding organs. The doctor usually inserts the mini-sling after making an incision in the vagina and with the use of a metallic insert, aligns the mini-sling in the pelvic area nearest the urethra.

The tension free vaginal tape sling is inserted when two abdominal incisions and one vaginal incision is performed by the surgeon. The surgeon will then insert a mesh made of polypropylene material into the vagina, wrap it under the urethra and around it. The surrounding tissue will then permeate the mesh and hold it in place.

The trans-obturator tape sling is also called a TOT. It is inserted by a surgeon to support the bladder. It is most preferred because of the ease of insertion since the surgeon has more control in accurate placement.

Transvaginal Surgical Mesh Brands

Several companies manufacture Transvaginal surgical mesh products that are being sold under a variety of brand names. Since the FDA warning, several devices have been recalled by companies due to the severe side effects seen in patients after implantation. Here are a few:

· AMS

· Avaulta™

· Bard 

· Boston Scientific

· Gynecare

· Johnson & Johnson

· Sofradim

· Uretex

These are major mesh brands; however, there are other brands that have not been mentioned. Contact our attorneys to see whether you qualify to file a lawsuit if you encounter symptoms such as pain and bleeding or any other problem associated with the use of Transvaginal surgical meshes.

The Problem with Transvaginal Surgical Mesh Implants

The problem with the Transvaginal surgical mesh implant is that it erodes the vaginal walls. Mesh erosion occurs when the mesh, instead of forming a strong bond with the weakened pelvic muscles, tends to adhere to the vaginal walls and as a result causes bleeding, pain and infection.

Surgery does little to help correct the situation in many cases of women with transvaginal surgical mesh complications as the pain persists even after subsequent surgeries. The biggest issue in these kinds of surgeries is trying to detangle the tissue from the mesh since tissue permeates the membrane soon after insertion.

Unfortunately, technology has not come up with better surgical methods for removing devices such as the surgical mesh. Until the time of discovery, patients with POP or SUI are advised to consider treatment methods other than Transvaginal surgical mesh.

Complications of Transvaginal Surgical Mesh Implants

One complication that comes with Transvaginal surgical mesh implants is the damage it does to the surrounding nerves. Unfortunately, nerves can make the already weak pelvic muscles collapse and become completely unable to even hold a small amount of urine in the bladder. This leads to neuromuscular disorders that may cause life changing complications. The nerves play an important role in enabling muscles does their job. If interference encroaches even into the nerves, organ failure may be inevitable.

Vaginal shrinkage is also associated with Transvaginal surgical mesh implants. The scar tissue that forms as a result of the implant surgery may build up and shrink the vagina. The space becomes smaller causing discomfort and pain. Bleeding may occur especially during or after sexual intercourse. Sometimes it may not even be possible to engage in sexual intercourse because of the pain and bleeding that may start on its own. Pain may also occur when a patient is voiding the bladder.

Emotional problems may then follow. It becomes psychologically traumatic when engaging in simple everyday events becomes impossible. For physically intimate partners, whenever sexual intercourse is hindered, the stability of the relationship may be affected and one or both spouses will end up feeling cheated and the other one guilty of something he or she cannot control. Therapy to cope with these problems may be required. If neglected, such situations damage families.

Transvaginal Surgical Mesh Claims

Statutory laws have set a time frame for claims of injury by surgical mesh. It is important to seek legal help in the event of personal injury and damages arising from use of Transvaginal surgical mesh. Why wait when you may be compensated for financial loss and other damages? Take action today and contact our product injury attorneys so your claim may be processed quickly.

Damages awarded for claims involving Transvaginal surgical mesh implants include earnings lost due to illness, lost earning capacities, emotional and physical suffering, past and future treatment expenses and other damages associated with the interference of the mesh with lifestyle.

Do not take problems associated with the transvaginal surgical mesh implant lightly. Since the FDA issued an alert to the public in 2008, there have been seven deaths reported from the use of these devices to control prolapsed pelvic organs. Speak to our qualified attorneys for legal redress.

No fees are required during the registration process. An evaluation is done to see whether a patient qualifies for a lawsuit. Fees are only paid after cases are won and our qualified attorneys manage to get you compensated by the guilty party. Contact us today to find out if you are entitled to file a lawsuit. Our attorneys are experts in securing you a full compensation for damages resulting from the use of the transvaginal surgical mesh implants.

 

Vaginal Mesh Lawsuit

vaginal mesh lawsuitProgress and Developments of the Vaginal Mesh Lawsuit

The vaginal mesh lawsuit saga erupted soon after the FDA issued an alert warning the public against implants of Transvaginal mesh in 2008 followed by an update in 2011. Suddenly, all the complaints that had been covered up came to light and exposed just how risky and far reaching the side effects of Transvaginal mesh implants were. Apparently, the FDA had received over 1000 complaints regarding the risks that come with the implantation of the vaginal mesh.

Previously, cases of complications from procedures involving the transvaginal mesh implants were heard but only the FDA and the involved companies were made aware of the magnitude of the risks involved. Most of the public population had little or no knowledge regarding the matter until the FDA spoke up.

Facts Leading to the Vaginal Mesh Lawsuit

The first company to produce vaginal mesh was Boston Scientific. Their product was designed to treat stress incontinence, a condition in which the bladder muscles are weakened. The weak bladder muscles lead to urine leaking whenever a little pressure is applied to the bladder through coughing, sneezing or even laughing.

Due to over a hundred complaints regarding the vaginal sling sold by Boston Scientific Company and sold under the brand name; ProteGen vaginal sling, the company recalled its product in 1999. A year before this recall, Johnson & Johnson released a similar product into the market branded under the name Gynecare TVT mesh.

Despite this move by the Boston Scientific Company, several other companies chose to put their economies first and ignore the safety of the consumers. They continued to market and sell their vaginal meshes that were designed to serve the same purpose as that one of the ProteGen.

One common factor these two products share is the fact that they were approved quickly by the FDA without satisfactory tests being carried out on their efficacy so as to ensure safety. In short, clinical trials and safety tests were ignored by the FDA and both companies.

How the Law Supports the Vaginal Mesh Lawsuit

According to the law, a plaintiff is free to sue for damages, both punitive and compensatory in the event of harm caused by the use of a product. This is also called personal injury.

In the case of vaginal mesh implants, the companies have gone against the law by placing the economic interests of the manufacturing company above the safety of the product user. They have also failed to establish effective and safe methods of the vaginal mesh implant removal. The mesh becomes difficult to remove even when surgical expertise is employed as it fuses with the tissues of the surrounding area, permeating into one complex mass of tissue.

After ignoring consumer safety, the companies still went on ahead to sell these devices even when the FDA issued alerts on the risky nature of the products and worse still, after the first innovator of the vaginal mesh, Boston Scientific, recalled their device from the market. Ethicon later recalled its device in June 2012.

The biggest mistake the companies responsible for selling vaginal mesh made was the failure to warn the public of potential risks, injury and complications that were very likely to occur with the use of these devices. Products that are released onto the market and those that come with potential risks are usually packed with a warning notice concerning their use or consumption. The public is also warned beforehand of the potential risks that they put themselves in every time they choose to consume or use such products. Unfortunately, in the case of the vaginal mesh implants, this was never done. It was negligence on the companies’ part.

The Court’s Current Stand on the Vaginal Mesh Lawsuit

The US District court of the Southern District of West Virginia has given the public the go ahead to register for vaginal mesh lawsuits across the country. This go ahead allows the public to sue the manufacturers of the vaginal mesh implants for damages incurred as a result of using their devices.

Chief Judge Joseph R. Goodwin consolidated the cases in the Southern District Court of West Virginia hearing that was held in October 2010. The chief judge has been assigned over 31,000 federal cases involving several manufacturers of the vaginal mesh implant.

The first few trials against Bard, the manufacturers of the Avaulta brand, ended with the plaintiffs winning the cases. One plaintiff involved in the personal injury lawsuit claimed that the transvaginal mesh implant had caused her severe bleeding and pain. She was awarded $2 million in damages, both punitive and compensatory. This judgment of the jury caused the lawsuit to become a bellwether case against Bard Inc.

Previously in a separate case, a California jury had awarded $5.5 million to a plaintiff, Christine Scott and her husband in a vaginal lawsuit against Bard, in July 2012. This was after the plaintiff underwent nine corrective revision surgeries for the implant surgery of Bards’ Plus vaginal mesh.

In February this year, a plaintiff by the name of Linda Gross was awarded $11.11 million after she filed a lawsuit claiming that she underwent 18 revision surgeries after the implant. The lawsuit was against Ethicon’s product, Gynecare TVT mesh.

The Vaginal Mesh Lawsuit Calendar for Federal Trials

Registration for the vaginal mesh lawsuit is still ongoing. Trial dates have already been set. However, the chances of application are still open for interested plaintiffs to see whether they qualify for the vaginal mesh lawsuit, However, it will soon be too late to register so you are urged to apply to our qualified attorneys at your earliest convenience.

July 2013 saw the start of the first federal trial against Bard Inc. Two trials are set for hearing in October 2013 in West Virginia and Georgia. Also scheduled for 2013, are the federal trials against American Medical Systems in December.

Hope through Filing for the Vaginal Mesh Lawsuit

If you suspect that you have been harmed by implants of the vaginal mesh, do not hesitate to speak to our qualified attorneys. They will guide you through all the legal measures necessary in ensuring that you are adequately compensated for damages. Damages covered in the vaginal mesh injury include medical bills incurred and set to be incurred in the future, lost capacity for earning, physical pain, lost earnings, compromised quality of life and other associated damages.

Do not let this opportunity for justice pass you by; act today! Contact us for a free case evaluation with a legal expert. The vaginal mesh lawsuit may be your only hope if you qualify for a case.

 

Transvaginal Mesh Implant

The Transvaginal Mesh Implant: A Cure or a Curse?

Transvaginal mesh implants have raised more questions than answers in the quest for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP.) These are conditions associated with weakened pelvic muscles which cause leakage of urine or the protrusion of organs in the abdomen through the vagina or rectum.

Considering the serious nature of the SUI and POP complications, the innovation of Transvaginal mesh, a device intended for treatment, was a breakthrough; or so healthcare practitioners initially thought. Unfortunately, it turned out to be a device that complicated and compounded these conditions further. The device led to such serious issues that painful revision surgeries were necessary for some patients.

Description of the Transvaginal Mesh Implant

Polypropylene is the main material used in Transvaginal mesh implants. It is a kind of plastic that is used to manufacture the non–absorbable synthetic Transvaginal mesh implant. Other types of the device include the composite, biologic and the absorbable synthetic Transvaginal mesh implant.

The mesh is usually net-like in structure. It is referred to as Transvaginal because of the system used to implant it; through the vagina. While the device can be inserted abdominally, when it is inserted through the vagina, it is usually more accurate and efficient.

A surgeon will usually make two incisions, one through the vagina and the other in the abdominal region. Depending on the design of the Transvaginal mesh implant, the incisions may vary between two and three. The procedure is not considered a high risk surgery.

Unfortunately, the Transvaginal mesh implant has caused severe complications in most patients. It leads to erosion of the mesh, pain, bleeding, perforation of organs near the mesh, hindered normal activity such as walking and sexual intercourse and other severe health problems.

Transvaginal Mesh Implant Brands

The first Transvaginal mesh implant to be approved by the US Food and Drug Administration (FDA) was the ProtoGen, a product from Boston Scientific. It was approved in 1996. Shortly after the approval of this Transvaginal mesh, Johnson & Johnson’s subsidiary company, Ethicon had their Transvaginal device approved by the FDA. It sold under the brand name Gynemesh PS. It was the first Transvaginal mesh implant of its kind to be dedicated to solving pelvic organ prolapse (POP) disorders.

Soon after the production, marketing and sale of these products, the ProtoGen was recalled due to a series of complaints about its side effects. Other manufacturers never bothered to find out why a similar product was recalled. Or did they know and chose to ignore the warning instead?

The manufacturers continued to sell their Transvaginal mesh implant brands but now sold them as a kit. The kit came with special tools and instructions for insertion for the surgeon and the transvaginal mesh implant. The first kits were approved for sale in 1997 and were specially designed to manage SUI disorders. They were branded by American Medical Systems and sold under the brand name AMS Apogee. Soon after, kits intended to manage POP disorders were released by the American Medical systems company and sold under the brand name AMS Perigee.

Other brand names of Transvaginal mesh implants from AMS include AMS BioArc, AMS Elevate, Monarc, Mini-Arc, Straight-In mesh and SPARC.

Other companies or corporations that sell Transvaginal mesh implants include Bard that trades under the brand names of Avaulta and Uretex. Ethicon (a subsidiary of Johnson & Johnson) is another manufacturer, selling under the brand name of Gynecare Systems.

Boston Scientific Corporation sells its Transvaginal mesh implants under several brand names. The brand names include: Prefix PPS Systems, Obtryx Curved Single, Advantage Sling System, Obtryx Mesh Single, Uphold Vaginal Support Systems, Lynx Suprapubic Mid-Urethral Sling System and Mid U Mesh Sling System.

Covidien Company, which was originally Tyco Healthcare, sells its Transvaginal mesh implants under the brand name IVS Tunneller. There are other Transvaginal mesh implants sold under various brand names from other manufacturers in the market.

What Specialists in Transvaginal Mesh Implant Procedures Have to Say

A doctor who specializes in the revision surgeries that follow the first implant surgery of the transvaginal devices is usually referred to as a Urogynecologist. These doctors specialize in pelvic floor abnormalities such as SUI and POP.

An article featured in the American Journal of Obstetrics and Gynecology stated that the ProtoGen, prior to its clearance, had never been clinically implanted on a human vagina. This article was authored by Wall L. Lewis, a licensed Urogynecologist.

Shortly after the research, doctors independently carried out their own clinical trials and tests and understood the risks associated with these Transvaginal implants. This was when the FDA paid close attention to the safety of the device. The risks associated with the device were serious and could not be ignored anymore if the public’s health was to be safeguarded.

This led to the FDA issuing warnings to the public on using the device. Consumers were urged to consider other treatment options before deciding on a Transvaginal mesh implant.

The Basis of Transvaginal Mesh Implant Lawsuits

After undue pain suffering, a member of the public decided to sue for Damages. In 2012, Christine Scott and her spouse sued C. R. Bard Inc. for Damages. The jury voted in their favor and they were awarded $5.5 million for her injuries. Shortly after, Linda Gross sued Ethicon for damages and was awarded $ 11 million dollars because of having to undergo 18 revision surgeries.

These lawsuits are the bellwether cases for pending Multidistrict Litigations in West Virginia. They are cases based on a product causing harm to a consumer because of the company’s negligence.

In these cases, both parties claimed that the companies did not put the safety of the consumer before their economic interests and instead went on to sell them faulty Transvaginal mesh implants that they knew would have serious complications. While it is easy to insert the product, it is nearly impossible to remove the transvaginal mesh once it fuses with tissues and organs, thus sentencing consumers to a life of misery and repercussions they never bargained for.

Financial Compensation for Damages Caused by the Transvaginal Mesh Implant

If you have been negative impacted by one of these devices, you may qualify for financial compensation. Do not hesitate to contact our product injury attorneys for legal assistance today! Complete the form on this page today or call to speak with a legal expert today. The registration and evaluation processes that are carried out to find out whether you qualify are completely free of charge. Fees are only when you receive a payment from the manufacturer of the Transvaginal mesh implant.

 

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