Transvaginal Mesh, Bladder Slings & TVT Sling/Tape
 
In October of 2008, the FDA issued a Public Health Notification warning of serious complications associated with use of vaginal mesh slings to repair SUI and POP, drawing upon more than 1,000 incidents of serious complications reported by nine surgical mesh manufacturers. The number of adverse events continued to climb after the warning. Nearly three years later, the FDA finally asked surgeons to consider all other treatment options before subjecting patients to the risks of vaginal mesh products such as the Avaulta Solo Synthetic Support System and the Avaulta Plus BioSynthetic Support System.
 
The FDA’s October 2008 Public Health Notification reported that of the more than 1,000 reports of complications received, the most frequent complaints included erosion through vaginal tissues, infection, pain, urinary problems, and recurrence of incontinence or prolapse. Some patients reported bowel, bladder, and blood vessel perforation during insertion; others endured vaginal scarring and mesh erosion that produced considerable pain and discomfort.

This FDA notification suggested that contributing factors could include the size and shape of the mesh and the mesh material. Some researchers have suggested that complications from Bard’s Avaulta vaginal mesh products stem from the synthetic mesh fabric, and/or the collagen layer added to Avaulta Plus and that these materials are not appropriate for permanent implantation in women.
Dramatic results of a randomized controlled trial of vaginal mesh used in cases of prolapse, conducted by Cheryl B. Iglesia, MD and several colleagues, were reported in the August 2010 Journal of Obstetrics & Gynecology.  For the study, 65 women were recruited between January 2007 and August 2009, when the study was halted due to predetermined study termination criteria for vaginal mesh erosion

The FDA’s July 2011 updated Safety Communication on surgical placement of mesh to repair pelvic organ prolapse emphasized that the risk of serious complication is not rare and that other options may expose women to less risk than transvaginal mesh procedures. In addition, the FDA points out that the exposure to greater risk comes with no evidence of clinical benefit or improved quality of life. In layman’s terms the risks do not outweigh the benefit. It’s bad enough that the product causes severe complications. Now it is clear that even if it didn’t, the product doesn’t work!

From 2008 to 2010, the FDA reports, five times as many adverse event complaints were received involving vaginal mesh slings than were received between 2005 and 2007. It’s no wonder: In 2010, at least 100,000 POP repairs used surgical mesh - despite increasing complaints and painful conditions that required additional surgeries or hospitalization to treat complications or remove the mesh.

Patients suffering from adverse effects of the vaginal mesh sling should contact a defective medical device attorney.  Many consumers regard the previously-undisclosed complications of Avaulta vaginal mesh slings as yet another problem with the FDA’s investigative and approval process. Avaulta vaginal mesh products were approved via a fast-track FDA process labeled 510(k). In the 510(k) process all a manufacturer needs to show is that the new product is “substantially equivalent” to one already legally on the market.If that showing is made, no clinical trials are required for FDA approval of the device. Unfortunately, patients who receive a device cleared by the FDA through the 510(k) process often act as human guinea pigs since the new devices have never been clinically tested for safety on humans.

A reputable scientific group, the Institute of Medicine, is calling for further examination of the 510(k) approval process, and for new legislation and stricter regulations regarding medical devices. The FDA announced that the agency is open to public comments on the report, and is holding public meetings throughout the summer and fall of 2011. A panel of obstetrics and gynecology experts is scheduled to lead a conference in September 2011 to discuss the balance of efficacy and risks related to vaginal mesh slings such as the Avaulta products manufactured by C. R. Bard.

Legal Help
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Surgical mesh, manufactured with polypropylene and intended for transvaginal insertion, is known by many names, including:

  Transvaginal Mesh
  Vaginal Mesh
  Bladder Sling Mesh
  TVT Mesh
  Transvaginal Tape

Traditional surgery to treat POP or SUI does not use plastic mesh. Instead, a woman's own tissue is used to support the organs.
Government Regulation
Vaginal Mesh Complications and Side Effects
The FDA has received many adverse reports regarding transvaginal mesh devices, including the Gynecare TVT sling. TVT systems typically involve mesh tape with vaginal sling surgery, also known as a TVT sling procedure, to correct urinary incontinence.  In the past three years, the FDA has received over 1,500 reports of complications arising from surgical mesh devices used to repair POP, and over 650 patients have filed lawsuits as a result of their injuries. During this time, there were seven reported deaths associated with POP repairs, three of which were related to the mesh placement procedure.

Transvaginal mesh implant complications include the following:

mesh erosion into the vagina, bladder, intestines and uterus
infection,
pelvic pain or neuropathic pain,
urinary problems, including incontinence,
development of urinary retention
bowel, bladder, and blood vessel perforation during insertion,
vaginal scarring,
dyspareunia (pain with sexual relations),
fistulas and recurrence of prolapsed organs

As consumer groups take the Food and Drug Administration to task over its slipshod regulation of medical devices, one hastily-approved medical device proves a serious risk to women plagued by stress urinary incontinence (SUI) or pelvic organ prolapse (POP). New studies show that Avaulta vaginal mesh slings can cause women severe pain, scarring, disfigurement, the need for multiple repeat surgeries and other permanent damage. If you have suffered pain or injury because of a mesh sling, contact a Florida product liability attorney at Hummer Law Offices today.

Vaginal slings are surgically implanted to give relief to women who suffer from embarrassing and uncomfortable conditions that result from hysterectomies, multiple vaginal deliveries, aging, obesity, chronic cough, or smoking. Stress urinary incontinence (SUI) is an involuntary loss of urine during a physical activity such as coughing, sneezing, laughing, or exercising. Pelvic organ prolapse (POP) describes the collapse of pelvic organs such as the bladder, uterus, or rectal wall into the vagina, which can cause vaginal bulging, rectal leakage, or constipation.

Complications
Transvaginal Mesh and Transvaginal Sling are medical devices that are surgically implanted to treat Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence(SUI).

SUI typically occurs in women after childbirth and/or pregnancy: Due to muscle weakness in the pelvic area, urine leaks from the body during activities such as coughing, laughing, exercising, etc. POP, known as Cystourethrocele, typically occurs in older women whose muscle and tissue groups in the uterus, bladder and pelvic region have become stretched and weakened. As well, women have an increased risk of developing POP with menopause and hysterectomy. Vaginal sling surgery is supposed to strengthen the internal organs and prevent them from coming into contact with each other by implanting mesh tape.

Since 2005 more than 1,000 TVT sling complaints from nine different manufacturers have been reported to the FDA, which culminated in a FDA safety alert in 2008 about serious complications associated with the use of mesh products--also known as pelvic or vaginal mesh and bladder slings-- in treatment of SUI and POP. A number of women have undergone surgeries to have the mesh removed. In 2009 the FDA issued another FDA safety alert. According to the FDA, about 1,500 reports were filed between 2008 and 2010.

In January 2012, the FDA ordered the makers of transvaginal surgical mesh products to study the risks associated with the products. The order came following the recommendation of an FDA advisory panel in September 2011. According to the FDA, between 2008 and 2010 the number of adverse events reports to the FDA about transvaginal meshes increased five times. Not all surgical mesh products are affected by the FDA's order; those that are implanted through the abdomen are not included.

In July 2011, the FDA warned that transvaginal placement of surgical mesh to treat pelvic organ prolapse may carry more risks than other surgical options, without any evidence of greater benefit. The agency stressed that this warning “warning does not apply to mesh placed abdominally, or to treatment for stress urinary incontinence”. An advisory committee will be meeting in September 2011 to discuss the safety and efficacy of the mesh products in those indications.

Before TVT slings were approved, POP and SUI were treated without mesh in a procedure called an abdominal sacrocpopexy, which uses the patient's own ligaments to support weakened muscles. Now, polypropylene mesh is woven through pelvic tissue and placed underneath the urethra, creating a support sling. The tape is designed to support the urethra when pressure is exerted. However, TVT lawsuits claim that many of the transvaginal mesh products have not met reasonable safety standards and that the manufacturers failed to warn of significant risks. Some experts believe the mesh to be a defective design (the Mentor O.B Tape vaginal sling was removed from the market due to a design defect) and that complications develop because it prevents surrounding tissue to receive nutrients. As well, the mesh can erode into the vagina, migrate or shrink, which results in urinary problems, pelvic pain, and infections.

Treatment
Treatment of these painful complications can require abscess drainage, intravenous therapy, and blood transfusion. In some cases, multiple surgeries are required to remove the mesh sling, although removal can be difficult if the mesh has disintegrated or grown into surrounding tissue. In such cases the damage is permanent.

Lawsuits by Manufacturer
Currently product liability lawsuits are being filed against a number of transvaginal mesh manufacturers, including Ethicon, a Johnson & Johnson subsidiary, American Medical Systems(AMS), Bard and Boston Scientific. The vaginal mesh lawsuits claim that the vaginal slings were negligently designed, causing pain and other complications.

Plaintiffs who have filed transvaginal mesh lawsuits claim that the mesh and/or slings used to treat their pelvic organ prolapse or stress urinary incontinence were negligently designed, thereby causing serious side effects such as mesh erosion, organ damage, chronic pain and other vaginal mesh complications.

Johnson & Jonhnson
Johnson & Johnson’s Ethicon Women’s Health & Urology division is responsible for manufacturing many transvaginal mesh devices. This division of Johnson & Johnson offers treatment solutions for a variety of female pelvic and reproductive organ health conditions.  Brand names of Johnson & Johnson/Ethicon’s transvaginal mesh patches include:

  Ethicon TVT
  Gynecare TVT
  Gynemesh PS
  Prolene Polypropylene Mesh Patch
  Secur

Johnson & Johnson subsidiary Ethicon and C.R. Bard vaginal mesh lawsuits have been consolidated in New Jersey state court.

Ethicon Gynecare transvaginal mesh lawsuits are set to go to trial in August 2014. Ethicon’s Prolift mesh went to trial in New Jersey and ended with the jury awarding the plaintiff $11 million in damages (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10; In re: Pelvic Mesh Litigation/Bard, No. L-6339-10).

Bard
Bard, based in Georgia, manufactures, distributes, and markets numerous medical devices.  Brand names of Bard’s transvaginal mesh patches include:

  Avaulta Plus™ BioSynthetic Support System
  Avaulta Solo™ Synthetic Support System
  Faslata® Allograft
  Pelvicol® Tissue
  PelviSoft® Biomesh
  Pelvitex™ Polypropylene Mesh

American Medical Systems (AMS)
American Medical Systems, based in Minnesota, produces SPARC, which is a type of transvaginal mesh patch designed to treat stress incontinence.

AMS mesh cases were scheduled to begin last December. AMS settled a number of cases for $54.5 million, and the company is expected to attempt a global settlement in many more of the 6,000 cases pending in federal court

Boston Scientific
Boston Scientific, based in Massachusetts, has been making medical devices for over 25 years. The company is also responsible for making potentially defective and dangerous transvaginal mesh systems effects, some of which are potentially fatal.  Boston Scientific’s transvaginal mesh patch brands include:

  Advantage™ Sling System
  Obtryx® Curved Single
  Obtryx® Mesh Sling
  Prefyx Mid U™ Mesh Sling System
  Prefyx PPS™ System

To date, the above manufacturers continue to make these potentially harmful TVT slings, despite warnings by the FDA and medical experts, and more than 1,000 known cases of women who have been seriously harmed by these medical devices.

The first Boston Scientific bellwether trial is slated for March 10, 2014. The second is set for trial on July 14, 2014.


As of January, 2014 more than 40,000 transvaginal mesh lawsuits have been filed against a number of TVM manufacturers, including C.R. Bard, Ethicon (a Johnson & Johnson subsidiary), American Medical Systems (AMS), and Boston Scientific. While some claims have been settled, approximately 3,000 TVM lawsuits a month are currently being filed, mainly against the aforementioned manufacturers.

While surgery may be necessary to alleviate the problems associated with SUI and POP. Implanted vaginal mesh slings are less invasive than surgery and sometimes can be inserted laparoscopically. They serve as a hammock to lift sagging organs and support them in their normal position in the pelvic cavity.

The Avaulta Solo Synthetic Support System is a permanent sterile mesh implant for long-term reinforcement of weakened pelvic muscles and tissues. It is made of non-absorbable monofilament polypropylene mesh. Avaulta Plus BioSynthetic Support System adds a porous, acellular (not made of cells) ultra-thin sheet of cross-linked collagen to the polypropylene mesh. The collagen layer serves as a protective barrier between mucosal tissue and the mesh, with holes for in-growth of host tissue and capillary vessels.

Not long after the Food and Drug Administration (FDA) approved vaginal mesh slings, patients began to report complications. Two products - ProteGen bladder sling and Mentor ObTape - have been removed from the market. But Avaulta’s vaginal mesh sling remains on the market, despite numerous complications reported and dangerous drug lawsuits filed by users of the device:

Chronic inflammation and infection
Extrusion of the devices
Mesh shrinkage or disintegration
Formation of abscesses
Vaginal discharge, erosion, and scarring
Perforation of bladder, bowel, or blood vessels
Pain during sexual intercourse
Injury to nearby organs
Recurring SUI and POP
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