Vaginal Mesh Implant Complications

Vaginal mesh devices, also known as bladder slings, have been linked to several complications in the past several years. According to most of such cases, the implants may potentially cause severe complications that could result to serious injuries that may corrective surgeries. These have led thousands of injured women to take legal actions such as filing of transvaginal mesh lawsuits against mesh manufacturers.

The above-mentioned mesh devices have been around since the 1990s, during which such implants were supposedly very much on demand. Medical experts say that they were initially used for the treatment of hernias, and later utilized in vaginal procedures for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Due to high demand, numerous medical companies manufactured their own versions of the device, which are mostly designed to treat POP and SUI only. Among the large companies that entered the vaginal mesh market are American Medical Systems, Inc., Boston Scientific, Inc., Ethicon, Inc., Cook Medical, Inc., C.R. Bard, Inc., and Mentor Corp. Remarkably, reports indicate that most of these companies are now facing lawsuits over complications associated with their mesh implants.

Reports of transvaginal mesh complications have started circulating in the public even before the implants themselves became popular, based on various media sources. Such reported complications include mesh erosion, infection, recurrent POP, and organ perforation. Initially, the U.S. Food and Drug Administration (FDA) stated that the occurrence rate of these complications is low. Later, however, the agency admitted in a warning notice that transvaginal mesh complications are not so rare after all. Some of the patients who were allegedly injured by the mesh implants state that they had to undergo a number of corrective procedures in order just to alleviate their conditions.

Numerous lawsuits involving transvaginal mesh implants were reportedly filed over the years as an increasing number of patients claim to have suffered from mesh injuries. Overall, the number of cases has reached more than 20,000. In fact, six transvaginal mesh multidistrict litigations have already been established by the Judicial Panel on Multidistrict Litigation. They are now proceeding in the U.S. District Court for the Southern District of West Virginia.

References:
fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm
prweb.com/releases/transvaginal-mesh-lawsuit/boston-scientific/prweb11521869.htm

Vaginal Mesh Lawsuits in 2013 Resolved in Favor of Plaintiffs

With the year 2013 coming to a conclusion, one may feel that this year was generally favorable to the plaintiffs as far as the vaginal mesh lawsuits that went into trial are concerned. The decisions handed down by the juries of the different courts that heard these lawsuits were in favor of the plaintiffs, with the defendants instructed to pay damages.

The two vaginal mesh lawsuits resolved by the courts for the year 2013 were the following:

Linda Gross vs. Ethicon

A decision finding Ethicon, a business unit of Johnson & Johnson, liable for the injuries sustained by Linda Gross was handed down by the jury in February this year after a month of hearing testimonies from different experts. This lawsuit which was heard before the court of Judge Carol Higbee of the Superior Court of New Jersey was the first of the thousands of pending vaginal mesh claims under his jurisdiction.

A GYNECARE PROLIFT vaginal mesh was implanted on Linda Gross for her pelvic organ prolapse (POP) and after a few years, she started experiencing severe complications. Even with the 18 surgeries she has undergone, including the very complicated mesh removal procedures, she is still far from recovery. She continues to suffer chronic pain and has to maintain multiple medications to ease the pain and discomfort.

A total of $11.1 million representing compensatory damages of $3.35 million and punitive damages of $7.76 million was awarded to Linda Gross. The jury found, as stated in its verdict, that Ethicon failed to properly warn of the risks associated with the transvaginal mesh device and that it also made fraudulent misrepresentations to the plaintiff.

Donna Cisson vs. C.R. Bard

In the middle of August this year, the vaginal mesh lawsuit of Donna Cisson against C.R. Bard was concluded with a decision finding the defendant liable for the injuries suffered by the plaintiff. Included in the multidistrict litigation (MDL) under the US District Court for the Southern District of West Virginia, this lawsuit was actually the first of four bellwether cases involving C.R. Bard.

A Bard Avaulta Plus Posterior BioSynthetic Support System was implanted on Miss Cisson in 2009 for the treatment of her pelvic organ prolapse. After only a few years, she started experiencing severe complications that resulted to mental and physical pain, permanent disability, and substantial deformity.

The jurors in this case declared that Donna Cisson was able to prove her claims that the mesh implanted in her was defective in design and that the defendant failed to provide adequate warning of the risks involved. The claimant, as a result, was awarded compensatory damages of $250,000 and punitive damages amounting to $1.75 million.

Impact Vaginal Mesh Decisions

For the year 2013, there would have been more vaginal mesh lawsuits going into trial but others did not push through for one reason or another. There were postponements in the scheduled bellwether cases and one claimant had to request the court for the dismissal of her vaginal mesh claim. Two other cases which were supposed to start trial were cancelled after C.R. Bard decided to settle the claims out of court.

The thousands of plaintiffs in the pending vaginal mesh lawsuits may have much to be optimistic about if these developments should be any indication. Legal observers have noted that these positive decisions may persuade the numerous defendants to settle pending claims instead of proceeding with the trials.

References:

• bloomberg.com/news/2013-02-28/j-j-owes-7-76-million-in-punitives-in-vaginal-mesh-case.html
• meshmedicaldevicenewsdesk.com/latest-in-the-litigation-concerning-mesh-and-medical-devices

Vaginal Mesh Complainant Ordered to Pay Cost after Requesting Dismissal of Claim

In his ruling issued on November 5, 2013, Judge Joseph Goodwin of the US District Court of West Virginia ordered a plaintiff in a vaginal mesh lawsuit to reimburse the defendant for the legal costs incurred during the preparation of the trial.

This developed after Linda Rizzo, the plaintiff, requested the court for a dismissal of her vaginal mesh lawsuit filed almost four years ago. After granting the dismissal, C.R. Bard, the defendant, asked the court to order the plaintiff to pay for the attorney’s fees and legal expenses for the acquisition of deposition transcripts and the plaintiff’s medical records.

It was earlier reported that Linda Rizzo was left no other choice but to request for a dismissal after her expert witness did not pass the board certification for the new sub-specialty of Female Pelvic Medicine and Reconstructive Surgery (FPMRS). This sub-specialty was only established this year with the first board examination given last June.

While this failure to pass the examination may not have affected the facts of the lawsuit, it was anticipated that it will hurt the case of Linda Rizzo. It is very unfortunate that this has to end this way for someone who suffered serious injuries.

Read More: Judge Rules Vaginal Mesh Plaintiffs Owe C.R. Bard

Endo Health Allocates $55 Million for Vaginal Mesh Lawsuit Settlement

Specialty pharmaceutical company Endo Health Solutions will allocate $55 million as settlement of vaginal mesh lawsuits filed by an undisclosed number of plaintiffs who have suffered serious injuries arising from their use of its product, Bloomberg reports.

The injury lawyer newswire reports that the company disclosed settlementpreparations in a recent deposition it has filed with Securities and Exchange Commission. It was not revealed which or how many of the vaginal mesh lawsuits will be involved in planned payout. This does not affect the majority of vaginal mesh lawsuits filed in state and federal courts against Endo Health and its subsidiary, American Medical Systems.

The Rottenstein Law Group, which helps clients injured by vaginal mesh devices, has been encouraged by the $55 million Endo Health settlement report. This development, taken with the recent victories of Linda Gross and Christine Scott, may bode well for the thousands of women injured by vaginal mesh devices.

J & J Interference in Medical Article Promoting Prolift Unacceptable, Experts Assert

For a company revered for almost a century for its credo on ethical behavior, the branding by an urogynecology expert as unethical the business decision of Johnson & Johnson officials is like a slap on their faces. This was how Dr. Anne Weber described the actions of the company executives in insisting to market the Gynecare Prolift vaginal mesh despite strong indications that this device may cause injuries to a lot of women already suffering from pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Internal communications presented in the trial revealed that researchers had warned of possible problems with the present materials used for the Gynecare Prolift. In addition, prototype testing of the vaginal mesh yielded a failure rate which was way beyond acceptable levels.

She also raised the issue of the company’s interference in the matter of the medical publication involving the Prolift. She contends that the conduct of the executives in funding the article which supposedly endorsed the product was scientifically unacceptable. To further prove her point, she highlighted the company’s move to delete the phrase “further studies needed to confirm the safety of the Prolift” from the article.

Read More: Ethicon Made Unethical Decisions Re: Prolift Mesh Product, Doc Testifies

$7.76 Million Punitive Damages Award in Prolift Vaginal Mesh Case Indicative of Jury’s Mindset, Rottenstein Law Group’s Principal Says

The New Jersey Superior Court jury’s verdict finding that Johnson & Johnson’s Ethicon unit should pay $7.76 million in punitive damages to a victim of Prolift vaginal mesh injuries indicates that the jury determined that Ethicon is not only responsible, but highly culpable, for claimant Linda Gross’s injuries, says Rochelle Rottenstein, principal of the Rottenstein Law Group, a law firm that represents hundreds of vaginal mesh claimants.

 

Commenting on the $7.76 million in punitive damages awarded to Linda Gross on Feb. 28 in her case against Ethicon Inc., the manufacturer of Prolift vaginal mesh, Rottenstein told the Associated Press that—even if the award is overturned or reduced on appeal—it “should give vaginal mesh manufacturers an idea of the jury’s mindset,” and that should encourage manufacturers to settle with the thousands of women who’ve filed claims against them for vaginal mesh injuries. (Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey)

 

The $7.76 million punitive damages award is on top of a $3.35 million compensatory damages award that the jury found Ethicon liable for earlier this week. Totalling $11.1 million, the damages are based on the jury’s finding that Ethicon failed to provide an adequate warning to Gross’s implanting surgeon, and on the jury’s finding that the Prolift’s instructions for use and marketing materials fraudulently misrepresented the product’s risks.

 

Read full story at PRWeb.com: $7.76 Million Punitive Damages Award in Prolift Vaginal Mesh Case Indicative of Jury’s Mindset, Rottenstein Law Group’s Principal Says

Vaginal Mesh Lawsuit Update: Rottenstein Law Group is troubled by Johnson & Johnson official’s admission of vaginal mesh failure rates of at least 20 percent

During a trial for a vaginal mesh lawsuit in New Jersey Superior Court in Atlantic City, a Johnson & Johnson project leader admitted vaginal mesh failure rates of at least 20 percent.

The Rottenstein Law Group is troubled by a Johnson & Johnson official’s testimony in a vaginal mesh trial that a prototype of a vaginal mesh implant failed in 20 percent of women within six months before the device even went to market in 2005, as reported in a Jan. 11 Bloomberg article.

J&J subsidiary Ethicon is currently in New Jersey Superior Court in Atlantic City defending a case (Gross v. Gynecare Inc., Atl-L-6966-10) brought by Linda Gross, 47, of South Dakota, who alleges that the company failed to adequately warn of the risks associated with the Gynecare vaginal mesh implanted to treat stress urinary incontinence and pelvic organ prolapse. Gross alleges that she received 18 surgeries to repair damage following the 2006 implantation of her Gynecare Prolift. This is the first of 1,800 vaginal mesh lawsuits set to go to trial.

Read full story at PRWeb.com: Vaginal Mesh Lawsuit Update: Rottenstein Law Group is troubled by Johnson & Johnson official’s admission of vaginal mesh failure rates of at least 20 percent

Another Vaginal Mesh Lawsuit Filed Against Ethicon

A new lawsuit has been added to the Ethicon vaginal mesh MDL in West Virginia, according to a recent court announcement. Pending before the court of Judge R. Goodwin are cases against five companies that remain subjects of numerous complaints arising from the alleged injuries suffered by women while using these vaginal mesh devices. This has prompted the parties concerned to request for a multidistrict litigation (MDL) management.

This new lawsuit is from a woman who underwent surgical procedures in 2009 for the repair of her pelvic organ prolapse condition using the Ethicon Prolift + M and the TVT Secur vaginal mesh devices. Shortly after being implanted with these devices, she started experiencing severe side effects and serious complications.

These Ethicon products, which were supposed to treat symptoms of pelvic organ prolapse and stress urinary incontinence, will cease to be sold within four months. According to the announcement of Johnson & Johnson, the parent company of Ethicon, this will give them sufficient time to “notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients.”

New Study Shows Imaging Could Help Physicians Evaluate Women for Transvaginal Mesh Suitability, Rottenstein Law Group Reports

A North Shore Long Island Jewish Health System study suggests a new imaging system could better determine if women are eligible for transvaginal surgical mesh to treat pelvic organ prolapse. This comes after several lawsuits have been filed and after several FDA reports about the problems associated with surgical mesh.

New York, NY (PRWEB) December 20, 2012

A new imaging system could help physicians evaluate a woman’s suitability for pelvic organ prolapse repair using transvaginal surgical mesh, the Rottenstein Law Group reports.

Medical equipment manufacturer Imalux said researchers at the North Shore Long Island Jewish Health System used its Niris 1300e Imaging System to image previously placed surgical mesh in the vaginal tissue and measure the thickness of that tissue. Older technologies such as X-rays, CT scans and MRIs cannot achieve a high enough resolution for transvaginal mesh imaging, the company said citing studies presented at the American Urogynecologic Society Annual Meeting.

Read full story at PRWeb.com: New Study Shows Imaging Could Help Physicians Evaluate Women for Transvaginal Mesh Suitability, Rottenstein Law Group Reports

Vaginal Mesh Use Complications

Medical devices known as vaginal meshes, slings and other supplies considered for its efficient application have been scrutinized by the people in the wake of mounting consumer complaints.

Erosion of the mesh and infections occurring within a year following surgery are not the only complications of vaginal mesh application; other potential risks may also be observed while the procedure is ongoing. One of them is the possibility of a punctured bladder. Since the surgeon’s view is limited during the procedure, the bladder is most likely punctured by the needle during the stitching process. Most of the time, the bladder part on the opposite side of the doctor while he is doing the stitching is most likely cut. Women with previous operations on their reproductive system are prone to this complication as well. Letting the patient void of waste water before the operation and placing a urinary catheter into the bladder help lessen this problem. At the same time, doctors should be careful in safely guiding the needle when the stitching is performed.

Bleeding is another type of negative incidence that may happen while the positioning of the synthetic sling is done. This problem may emerge during the first cuts to the vaginal wall or the suturing of the sling. The doctor will then assess if there is a need for suture ligation, and this will be determined by how severe the bleeding is. For excessive bleeding, however, the vaginal wall should be closed and a vaginal gauze pack should be kept in place for hours until bleeding stops. If needed, blood transfusion may be done.

Prompt identification of these two potentially serious complications during surgery is essential for the patient’s fast recovery and safety. According to the clinical findings on post-surgical complications, unrecognized perforation of the bladder have led some patients to developing erosion of the mesh. Erosion of the mesh may be gravely dangerous, especially if there is a need to remove the mesh from the body, since there is a possibility for the body tissues surrounding it to be removed together with the mesh. Stripping the mesh device from the body would also mean removing some of the tissues attached in to it.

Artificial mesh devices and slings are the most advanced medical technology used in the repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Many people have shared successful experiences with these devices. However, there were also patients who acquired its complications. Even when many medical experts consider these devices as the best remedy for POP and SUI, surgical mesh sling cases are increasingly filed against mesh marketers.

References:

• webmd.com/urinary-incontinence-oab/news/20110713/fda-surgical-mesh-for-pelvic-prolapse-risky-unnecessary
• laborie.com/articles/complications-of-synthetic-mid-urethral-slings