Articles Posted in transvaginal mesh

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For anyone involved in a civil lawsuit, the question of whether the case should be removed from state to federal court is an important one.
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Technically, both parties should be able to expect a fair legal proceeding no matter the venue in which the case is heard. However, civil case defendants in large tort actions, such as transvaginal mesh claims, tend to view a federal court venue as a strategic advantage. They will often fight very hard to have a case removed from state court to federal court if there is an opportunity to do so.

When transvaginal mesh claims are filed as a class action or a mass action, it can improve the defendant’s odds of having the case removed to federal court, per the Class Action Fairness Act of 2005. The law expanded the criteria under which such claims must be removed to federal court.
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Transvaginal mesh has been used as a primary treatment in repairing vaginal damage after childbirth and in treating incontinence. While the number of lawsuits involving transvaginal mesh is on the rise, new research indicates that the use of mesh product offers no variation in cure rates. The study suggests that many women who were injured by transvaginal mesh also didn’t see any remedial medical benefit.

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Injuries caused by transvaginal mesh are known to be severe. Our Massachusetts transvaginal mesh attorneys are dedicated to helping the victims of dangerous medical products. We are also committed to staying abreast of topical issues in this area, including research surrounding the benefits and dangers of medical devices. According to the Georgetown University study (published in the September issue of Obstetrics and Gynecology), there were no variation in cure rates between those who did and did not have transvaginal mesh.
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Many women suffering from stress urinary incontinence (SUI) or from pelvic organ prolapse (POP) had a transvaginal mesh device implanted. Transvaginal mesh devices provide an alternative to traditional methods of strengthening the muscles in the pelvic area to address these health problems. The supposed ease of use and other alleged benefits of transvaginal mesh made these products very popular when they were first released onto the marketplace. Although there have been reports of problems with TVM devices, the medical products are still used on many women to this day as a treatment method. danger-sign-1-1199939-m.jpg

Unfortunately, our Boston transvaginal mesh lawyers know that there are serious risks associated with the use of transvaginal mesh in surgical procedures. If you have had a procedure done and your doctor used transvaginal mesh, it is important to understand the signs and symptoms of the most common problems so that you can get medical help promptly if your device starts to cause issues.
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Recently, our Boston transvaginal mesh lawyers reported that a mistrial had been declared in a bellwether transvaginal mesh case. While the need to restart the trial caused a delay in the resolution of this important case, WOWK TV now reports that the claim was resolved in the plaintiff’s favor. gavel-952313-m.jpg

The case involved a Georgia woman who filed a lawsuit against C.R. Bard Inc., the manufacturer of the Avaulta Plus Posterior BioSynthetic Support system. The transvaginal mesh system was implanted in the plaintiff in an effort to treat pelvic organ prolapse, a condition that causes the organs in the pelvic area to intrude on the vaginal wall. Unfortunately, C.R. Bard’s transvaginal mesh product failed to work as promised and caused serious harm to the injured Georgia woman.

As a result of the complications she experienced, the victim alleged that the company was negligent, that there was a design and manufacturing defect, that the company failed to provide adequate warning of the risks, and that both express and implied warranties were violated.

Transvaginal Mesh Case Resolved for Plaintiff
The Georgia woman taking action against C.R. Bard indicated that she had been seriously harmed as a direct result of problems with the mesh product. She alleged that she had suffered pain and permanent injury as well as developed a substantial physical deformity because of the mesh. Because of her injuries, she reportedly required multiple revisions surgeries.

The case brought by the plaintiff was one of more than 20,000 similar cases pending throughout the United States. Like the other cases, it was consolidated in a multi-district litigation, which means that one judge is able to hear multiple cases that are grouped together because plaintiffs were injured by a similar defective or dangerous product. The case was not a class action because each individual plaintiff maintains his or her own claim and seeks compensation for his or her own specific losses. It was, however, a “bellwether” case because its outcome could have an impact on future settlement or litigation.

The outcome of the case was thus important to the thousands of patients who are waiting to have their own day in court to hold manufacturers of transvaginal mesh responsible. Fortunately for those plaintiffs, the first bellwether trial had a positive outcome for the plaintiff. In fact, the jury awarded the plaintiff $250,000 in compensatory damages and another $1.75 million in punitive damages.

While this case does not guarantee that future plaintiffs making a claim will necessarily get the same outcome or similar results, it does bode well for injured victims.

Companies facing millions of dollars in compensatory and punitive damages may be eager to make a settlement offer with injured victims to try to limit the company’s potential exposure to losses in a lawsuit. While injured victims can benefit from this, it is also important for victims to understand what a fair settlement offer is and to ensure that they don’t accept less than they deserve.
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Recently, our transvaginal mesh plaintiff attorneys reported that the first bellwether case in a transvaginal mesh lawsuit had been resolved, with the plaintiff being awarded $250,000 in compensatory damages and $1.75 million in punitive damages. Just a few short days later, WOWK TV reported that a second transvaginal mesh case settled. to-sign-a-contract-3-1221952-m.jpg

The terms of the settlement have not been released and are confidential, according to the reports. However, since this settlement closely follows the case resolved in favor of the plaintiff earlier this August, the cases thus far seem to be showing a trend of going in favor of the plaintiffs. Although past cases cannot guarantee future results, this could be a good sign for the injured victims who were harmed by transvaginal mesh devices.

Second Transvaginal Mesh Case Resolved
The second transvaginal mesh case, like the first, was brought against mesh manufacturer C.R. Bard Inc. The injured victim in the case asserted that she had been implanted with a C.R. Bard mesh product called the Avaulta Solo Anterior Synthetic Support system as a method of treating her pelvic organ prolapse (POP). The procedure took place in 2008.

Unfortunately, the mesh quickly began causing serious problems. The plaintiff indicates that the C.R. Bard product caused her to experience mental and physical pain and suffering; physical deformity and permanent injury. The mesh also reportedly caused an infection, interfered with marital relations between the plaintiff and her husband and necessitated that she undergo six corrective revision surgeries.

The victim sought damages to cover the costs of medical bills and to compensate her for pain and suffering and mental anguish. Additional punitive damages were anticipated, especially after the initial trial resulted in such a large punitive damage award by the jury.

The trial for this second bellwether case was supposed to start on the August 21st, but since a settlement agreement was reached, there is no need for the claim to be heard in the courtroom. The confidential settlement means that other injured plaintiffs who were hurt by transvaginal mesh products will not know what amount of money the injured victim received in this case. However, the fact that the case did settle before trial could potentially indicate that the company is going to be more amenable to settling rather than risking another multi- million dollar jury verdict.

It is important to realize though, that while these early cases have been good news for plaintiffs, there are another two bellwether cases upcoming that could have different results. As the WV Gazette indicates, there is a chance that the next trial will result in an outcome that favors the defendant.

The next trial is scheduled to begin on October 8 and has been described as a case that the defendant’s picked because of the thought that it was a winnable case for the defense. Even if the defense is successful in the next claim, however, future plaintiffs with proof of the harm the vaginal mesh caused them may be able to successfully settle their claims or receive large damage awards from a jury who finds in their favor.
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A new trial is underway in the transvaginal mesh case of Cisson et al v. C.R. Bard, Inc, after the case had ended in a mistrial last month.
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Our Boston transvaginal mesh attorneys recognize that this case is significant because it is the first of some 23,000 cases set to go before the U.S. District Court for the Southern District of West Virginia. The court is handling the cases, which each claim the mesh devices caused complications that were both painful and serious.

In the Cisson case, the plaintiff, a 54-year-old public health nurse, alleges that the surgical device, known as the Avaulta Plus vaginal mesh, made by C.R. Bard Inc., was implanted in her and caused her to suffer internal pain and bleeding. She had to undergo several surgeries in order to have the device removed.

This company alone faces some 3,600 claims. Other companies facing significant transvaginal mesh litigation include Johnson & Johnson, Boston Scientific Corp. and Endo Health Solutions Inc.

Plaintiff attorneys in the Cisson case are arguing that C.R. Bard ignored warnings from the manufacturer of the plastic compound used in the device that it was not intended for permanent implantation in human beings. In the previous trial, defense lawyers had attempted to argue that the plastic compound used in the device and the final product were not one in the same, and therefore C.R. Bard hadn’t violated any safety standards.

Last month, the trial was only two days in when U.S. District Judge Joseph Goodwin halted the proceedings, in the midst of testimony from a Florida gynecological expert who strayed into testimony regarding the marketing of the devices. The information came in response to a question from a plaintiff attorney, who had asked what evidence exists to support the opinion that the Avaulta Plus mesh product is dangerous and defective. The witness testified that the basis for this opinion is rooted partially in the fact that he is called upon to remove so many of them and also that they are no longer available on the market for implantation.

Previously, the judge had ruled that plaintiffs weren’t allowed to mention that the defendants had withdrawn their products from the market last year. The judge said the “bell could not be unrung,” and the jury would be hard-pressed to disregard that information. It was the first time in the judge’s 20 years on the bench that he had declared a mistrial, he said.

In the opening statements of the new trial, plaintiff attorneys have asserted that C.R. Bard:

  • Knew of the risks associated with the transvaginal mesh products and did nothing to warn doctors;
  • Failed to do clinical testing or studies in order to fully know the risks of the product;
  • Did not conduct studies on how to remove the products;
  • Marketed and sold the products knowing that the material used to make it wasn’t designed for implantation in humans;
  • Failed to tell doctors that the product was unfit for human use.

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Transvaginal mesh implants were supposed to provide relief to women suffering from pelvic organ prolapse and stress urinary incontinence.
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These are conditions that often plague women after they have undergone a hysterectomy, menopause or child birth. SUI is a leakage of urine during certain moments of physical activity, while POP is when the pelvic muscles weaken to the point that the bladder, rectum and uterus drop into the vagina.

As awful as these conditions are, our Boston transvaginal mesh injury lawyers have heard patients describe the one-time remedy as even worse.

Transvaginal mesh, also known as bladder slings, have been shown to result in major, long-lasting complications for patients. It’s believed the number of transvaginal surgery patients is somewhere in the neighborhood of 550,000 to 600,000.

A number of doctors with patients who have undergone the transvaginal mesh surgery have reported that their patients have suffered pain so severe that they have contemplated taking their own lives. Sadly, in a few cases, they have done so.

The implants, ineffective for their intended purpose, have also caused a long list of complications on their own. Those complications, urinary problems and infection. In some cases, blood vessels, bowels and the bladder were perforated during the actual insertion. The erosion of the materials, which we now know in many cases were never suitable for human implantation in the first place, has led to severe vaginal scarring and further injuries. This has led to excruciating pain for many patients.

Some of the descriptions given by sufferers:

  • A feeling as if one is sitting on razor blades;
  • An intense burning and tearing sensation anytime one attempts to engage in sexual activities;
  • A sharp scratching feeling as the mesh protrudes through the vaginal walls;
  • An intense pain so severe it feels like a migraine that stretches from the knees to the navel;
  • Dagger-like, stabbing pain anytime one attempts to urinate.

Even powerful pain medications often do little to alleviate these symptoms long-term. Some women report being unable to sit, drive and in some cases even work.

Some mesh patients report being told for years that despite their pain, nothing was wrong. This only served to further deepen their depression.

While there is revision surgery available to have the mesh removed, it’s rare that eroded mesh can be removed completely. In addition to surgery, patients may require IV therapy, blood transfusions and drainage of hematomas or abscesses.

Endo Health, one of the primary makers of the mesh products used on patients, recently settled a small portion of their lawsuits for about $54.5 million, following an $11.1 million verdict in favor of a South Dakota woman. The plaintiff had alleged the product was defective and the company failed to warn, leaving her to cope with permanent scarring and ongoing bouts of extreme pain.

While the jury did not find the product to have been defective, they did find that the defendant failed to offer an adequate warning about the potential dangers of the product and also made fraudulent representations regarding the product to both the doctor and the patient.
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Transvaginal mesh (TVM) products are currently the subject of thousands of lawsuits brought by patients who had the surgical mesh implanted to treat pelvic organ prolapse or stress urinary incontinence.

The thousands of victims suffering from the dangerous side effects of TVM have to live with their story every day and have to cope with the ongoing pain and problems. Many people, however, may be unaware of TVM, of its dangers to patients or of the broader risk illustrated by this defective medical device. 167744_black_5.jpg

Recently, PBS aimed to draw more attention to the issue of transvaginal mesh products in the documentary entitled Need to Know. The documentary aired for the first time on March 22, 2013. Our Boston transvaginal mesh attorneys know that every patient who experienced transvaginal mesh complications deserves some type of compensation but that many people aren’t aware of their rights. Programs such as the Need to Know segment of PBS can help to educate patients and the public about what went wrong with TVM products.

The Problem with Transvaginal Mesh Products

Transvaginal mesh products can cause a number of serious health problems once implanted. Some of the potential complications include:

  • Erosion of the mesh.
  • Pain, especially during sexual intercourse.
  • A relapse of the pelvic organ prolapse.
  • Puncture/perforation of the bowels, intestines, bladder or blood vessels near to where the mesh was in the vaginal wall.
  • Urinary/incontinence problems.
  • Vaginal bleeding, chronic discharge or drainage.
  • Vaginal infection.
  • Scarring of the vagina.
  • Shortening of the vagina

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These side effects occur far too often and leave many patients struggling to get medical treatment to try to resolve the complications. Often, multiple complex and expensive surgeries are required, putting patients through a terrible ordeal.

All of these serious side effects raise the question: how did this product ever get on the market? PBS largely focuses on this issue in its Need to Know Documentary because it is an issue that led not just to dangerous TVM products but also to many other dangerous medical devices as well.

The problem is that the medical device came to market under special 510(K) rules. These rules allow for a device to be fast-tracked as long as there is already a substantially similar product on the market that has never been subject to a formal recall.

TVM was thus pushed through because it was substantially similar to a previous existing product. There was little testing or oversight of the new TVM products nor was their verification that the device they were based on was still considered safe. Instead, the medical device came to the market and caused thousands of patients to get hurt because of the lack of proper testing and oversight.

The PBS segment raised attention to this very important issue and it is one every American should be very concerned about as more dangerous devices like TVM could find their way into doctor’s offices and hospitals nationwide.
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