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Transvaginal Mesh | Sling Side Effects

Gynecare Prolift and Bard Avaulta System Medical Devices

Transvaginal Mesh

Transvaginal Mesh and Sling Complications

If you’ve had a trans vaginal sling surgery procedure, keep reading.
You may have good reason to speak to a medical device attorney/lawyer.

We are representing victims throughout the United States who are suffering complications stemming from the transvaginal mesh such as the Avaulta vaginal mesh, the Gynecare mesh, the Avaulta vaginal mesh system, and other mesh manufacturers.

The problem with the transvaginal mesh is that it causes erosion through the vaginal epithelium, infection, migration or movement, painful sexual intercourse, vaginal scarring, intense bowel and bladder pain, and the recurrence of incontinence.

If you believe you or someone you love has been affected by transvaginal mesh, please contact one of our specialists at 800-718-4658.

One transvaginal mesh manufacturer, the Mentor O.B. tape vaginal sling, has been taken off the market due to a design defect.

All of our clients who had complications have had additional surgery.

Our experts believe that the mesh is based on a defective design, which causes the complications. One possible theory is the sling prevents the surrounding tissue from receiving nutrients, causing complications. All of our clients have either had migration and/or erosion and intense pelvic pain, vaginal scarring and more.

The Law Offices of Nadrich & Cohen are investigating from coast to coast victims who suffered severe side effects due to the Gynecare Prolift Total Pelvic Floor Repair System, the Bard Avaulta system and other vaginal mesh and bladder sling products. There was a recent October 2008 FDA Public Health notification of the complications associated with the trans-vaginal placement of surgical mesh.  The problem with these devices which are used to treat Female Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) are that due to their make up of polypropylene mesh the mesh causes infections and adverse reactions to the surrounding tissue resulting in severe complications.  
 
What happens is that the mesh erodes into the vagina or can move or shrink causing urinary problems, pelvic pain, and infections.  Obviously, this is extremely painful, including extreme pain during sexual relations, fistulas and reoccurrence of prolapsed organs and neuropathic pain. These are very serious complications.

The complications are as follows:

Unfortunately, most side effect victims have to undergo revision surgeries and/ or blood transfusions, IV therapy, abcess of drainage conditions - all of which can take months or years to recover from.

Latest News

What The Real Problem Is With The Transvaginal Surgical Mesh

We believe the defective nature (side effect problems) of the sling mesh is because the transvaginal surgical mesh devices were fast tracked through the FDA approval process under a special fast track approval system which bypasses many of the extensive necessary required safety testing and regulatory procedures of other medical devices prior to their approval.

A fast track approval system is called a 510(k) exception which grants a medical device maker the ability to bring a new medical device or product to market much faster without first establishing safety records through an extensive pre market safety testing process. The medical device manufacturer’s ability to fast track this process is to merely state in its submittal documentation in support of the new device that the new device is “identical” to the company’s previously approved FDA medical device.

Unfortunately, we believe that’s what happened with the transvaginal mesh medical devices which has flooded the market in the past 10 to 15 years. Sadly, these devices have resulted in an exceptional high rate of serious side effects.

There are currently more than 3,000 reported adverse reports of side effects from these mesh products including infections, breakage, shrinkage, migration and attaching to the surrounding tissues. The mesh erodes into the walls of the vagina causing tremendous pain and difficulty during sexual intercourse. We have many such cases.

The FDA will be conducting a further hearing in September 2011 with outside experts to determine if these transvaginal mesh products should remain approved through the 510(k) fast track approval process due to the large number of documented side effects.

Latest Press Announcement

FDA: Surgical Placement of Mesh to Repair Pelvic Organ Prolapse Poses Risks
(Click to read full press release)

FDA Advisory Warning

The FDA on July 14, 2011 issued an advisory warning due to the numerous reports that the trans vaginal mesh sling implants used for Pelvic Organ Prolapse have been slipping out of place. The FDA review concluded that the vaginal mesh/sling product exposes patients to serious side effects. The FDA further stated that there will be a September, 2011 meeting of outside experts to again review all the data and make recommendations how to proceed.

The FDA indicated that patients and their doctors should consider other forms of treatment.

Over 100,000 women have been treated with surgical mesh for Pelvic Organ Prolapse since 2010 with 75,000 implanted vaginally.

There have been at least 3,800 adverse injury reports in connection with mesh / sling trans vaginal products.

As Trans Vaginal Mesh Sling lawyers we have been representing vaginal mesh/sling side effect victims for years - from coast to coast - in all 50 states.

We have hundreds of cases of women who have suffered serious side effects including mesh erosion and mesh migration into the vaginal walls and surrounding tissue. Unfortunately, these confirmed FDA side effects are apparently not rare problems.

We are encouraging our clients to send adverse event reports to the FDA so the FDA can ultimately take these products off the marketplace.

In their Advisory Alert the FDA stated it is important that patients and health care providers have access to the adverse event information the FDA has compiled.

Erosion is when the device protrudes, contracts or shrinks. Erosion of the mesh through the vagina is the most common and most reported sling/mesh related problem. Unfortunately, the erosion will cause at least one revision surgery to repair and is very difficult on the patient. We have many clients who have had multiple surgeries.

Mesh contraction or shrinkage is an additional side effect of the trans vaginal pelvic organ prolapse procedure cited by the FDA and cited in published scientific medical journals. Reported side effects included vaginal shortening, vaginal tightening and severe vaginal pain.

Of course, erosion, contraction and mesh migration leads to pelvic pain, difficulty in sexual intercourse, or even the inability to have sexual intercourse. Many of our client’s husbands and boyfriends experience great pain and irritation to their penis during intercourse.

We are actively investigating, signing up and representing vaginal mesh side effects victims from coast to coast in all 50 states.

See the FDA July 2011 Advisory opinion by clicking here:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

Trial of Synthetic Mesh in Pelvic Surgery Ends Early

To repair the uncomfortable and potentially dangerous condition called pelvic organ prolapse — a weakening of the muscles and ligaments that support organs like the bladder and uterus — more gynecological and urological surgeons have been turning to a synthetic mesh that shores up the vaginal wall. But now researchers are reporting that women who received the mesh had so many complications that scientists were forced to halt a clinical trial early. The trial randomly assigned 65 women with prolapse to undergo surgical repair either with vaginal mesh or with a more traditional procedure, colpopexy, that uses the patient’s own ligaments to support the sagging muscles. In an article in the journal Obstetrics & Gynecology, the researchers say safety reviewers observed that more than 15 percent of the patients who received the mesh experienced erosion, a potentially serious complication in which the skin splits and the mesh protrudes, often resulting in pain and infections. The trial, which began in 2007, was stopped in August 2009. In 2008, the Food and Drug Administration had issued a warning that the vaginal mesh had been associated with complications, but it said the problems were “rare.” The lead author of the new report, Dr. Cheryl B. Iglesia, director of female pelvic medicine and reconstructive surgery at Washington Hospital Center in the District of Columbia, said it made two important points.“The bottom line is not only there were more complications,” she said, “but the mesh didn’t prove any better than traditional surgery.”

Source: NY Times
Author: Roni Caryn Rabin
Published: October 22, 2010

In Re Bard Litigation

On October 12, 2010, Judge Higbee of the New Jersey State Court, Atlantic County, ruled that all Transvaginal Mesh cases (including our law firm’s) will be subject to centralized management without any Mass Tort designation for all past and present filed complaints and all future complaints for transvaginal mesh cases. This is known as In Re J&J litigation and In Re Bard litigation. The cases will all be separate going forward, but coordinated in one large action against the same defendants.

If you or a loved one had implanted a transvaginal mesh / sling medical device and have suffered complications, including corrective or subsequent surgery, please contact our law firm at 800-718-4658. We presently have over 100 transvaginal mesh victim cases that we are currently investigating, all of which have had subsequent or corrective surgery or are scheduled for corrective surgery.

Since 2005, in excess of 1000 victims have suffered serious complications from the transvaginal mesh device. In October 2008, there was a Public Health warning by the FDA sent to doctors and hospitals concerning the serious consequences of the Transvaginal Mesh placement

» Sling Mesh FDA Announcment

Vaginal Mesh Bladder Sling side effects caused by the Avaulta and Gynecare Vaginal Sling Mesh Systems

There are very serious consequences for women who have been implanted with the Gynecare and Avaulta vaginal sling systems. These serious side effects include significant mesh complications such as infections, vaginal scarring, mesh erosion and mesh migration or movement. If you or a loved one has suffered from these side effects from either  the Avaulta or Gynecare vaginal sling systems contact the lawyers at http://www.personalinjurylawcal.com/vaginal-mesh.php. Contact one of our intake specialists at 1-800-718-4658. We are investigating Vaginal Sling Mesh side effects claims in every state.

The problem is that the systems may cause erosion, extrusion of the mesh sling or migration  (movement of the mesh in the body). We have hundreds of women who we represent across the country who have either had to endure additional surgeries to  remove or replace the mesh or are scheduled for corrective surgery. These problems were addressed by the FDA in a 2008 public warning regarding side effects with the transvaginal mesh bladder slings. There have been at least more than a thousand reports of complications from the Bard Avaulta  and Gynecare sling systems. We are actively investigating cases against the manufactures Bard and Gynecare/Johnson&Johnson. Please contact us to see if you have a claim. We are contingency lawyers which means  there is no charge to you unless we first obtain a recovery against the manufacturer. When you our visit website please complete the free case evaluation form or contact one of our intake specialists at 1-800-718-4658.

If you are injured or suffered side effects from the Gynecare Prolift or Bard Avaulta mesh products, also known as the Bladder Sling, please contact us immediately.  Remember, there are time limitations for you or your loved one to bring claim.  If you do not bring a timely legal claim , your rights to bring a claim could be barred.  Our law firm is highly experienced in representing clients who suffered side effects due to a defective medical product.  We are actively reviewing vaginal mesh and bladder sling side effect cases nationwide. If you or a loved one has been seriously injured due to these mesh or sling products, please contact us immediately or complete the contact form on the right.  We are contingency lawyers and will take your case on a contingency basis.  This means there is never any cost to you unless we first obtain a recovery.

We are currently investigating cases of victims throughout the country who have had to endure horrible side effects from Transvaginal Mesh/ Sling medical devices which are surgically implanted to treat Pelvic Organ Prolapse and/or Stress Urinary Incontinence. These conditions occur mostly after childbirth and during pregnancy.

The manufacturers of the Transvaginal Sling and Mesh products are:

The FDA has reported that the nine surgical mesh manufacturers have provided over 1000 complication reports, from the sling including infection, vaginal scarring, bowel or bladder perforation, erosion through the vaginal wall, as well as the onset of prolapse or incontinence.

We are investigating cases of women who have had complications including corrective surgery. Remember: the Mentor OB vaginal sling/tape was taken off the market because of a design defect. Many believe that the design of the mesh causes the side effects. The belief is that the mesh interferes with the surrounding tissue from receiving its necessary nutrients and oxygen.