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Transvaginal Mesh: Injuries and Your Rights

serious complications associated with surgical mesh for transvaginal repair of POP are not rare.

Are you suffering complications as a result surgical mesh? Do you have questions? Concerns? Speak to a medical device attorney today about your case.

1-800-471-3980

Surgical Mesh & Transvaginal Insertion: A brief history of the issues

Surgical mesh has been used to repair damaged tissues for more than half a century. Within the past 30 years, that use has expanded to the transvaginal repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

In October of 2008, the FDA released a Public Health Notification in response to complications associated with surgical mesh devices used to repair POP and SUI. More than 1000 reports of complications were filed between 2005 and 2007 by nine device manufacturers.

In the three years that followed, 2,874 more reports of complications were filed with the FDA, prompting an update to the FDA's safety communication regarding transvaginal placement of surgical mesh. Reported complications involve mesh made by numerous manufacturers, including Boston Scientific, American Medical Systems, Inc. (AMS), C.R. Bard, Inc., and Johnson & Johnson.

In the July 2011 safety update, the FDA stated unequivocally that "complications associated with surgical mesh for transvaginal repair of POP are not rare." They also warned that regulatory changes may be ahead for mesh used in transvaginal POP repair.

As of June 2012, surgical mesh products are still regulated as a Class II device; the considered change is to make the mesh used in these repairs a Class III "which would require manufacturers to submit premarket approval applications, including relevant clinical data for these devices."

GPW's attorneys have experience with both state and federal pelvic mesh cases. If you have been injured by surgical mesh, or are concerned about your rights, you can speak with a transvaginal mesh lawyer free of charge or obligation; email or call toll free, 1-800-471-3980.

Mesh & Urogynecologic Procedures

The diagnosis and treatment of urinary incontinence and female pelvic floor disorders are practiced under a subspeciality of urology and gynecology known as urogynecology. Urogynecological issues are quite common, with some studies indicating more than half of all women will be affected by one of these conditions in their lifetime.

Surgical mesh is intended to act as a reinforcement to soft tissue or bone where where there is weakness. Transvaginal mesh refers to the method in which the surgical mesh is inserted: through the vagina.

Stress urinary incontinence (SUI)
Losing urine during physical activity is known as stress incontinence. The activity may be excersize, walking, or jumping, or can be as simple as coughing, laughing or sneezing.
Surgical mesh has been used to treate SUI be the use of "slings" that are inserted under the urethra to help prevent urine leakage during activity.
Pelvic organ prolapse (POP)
When the muscles holding pelvic organs in place weaken or stretch, allowing organs to bulge into each other, this is known as pelvic organ prolapse. Often caused by childbirth, it is estimated that 30-50% of women will suffer from some degree of POP during their life. Only a few, however, will have symptoms that require treatment.
Mesh has been inserted through the abdomen (transabdominally) to repair certain types of POP since the 1970s. When used transvaginally, mesh has been used to make repairs to the front and back walls of the vagina, and to the top of the vagina.

What is surgical mesh made of?

Most meshes cleared for use in urogynecologic procedures are polypropylene, a non-absorbable synthetic mesh. This is the most commonly used type of surgical mesh, but there are a variety of types of materials, synthetic and biologic, absorbable and non-absorbable. Surgical mesh can be categorized in four general types:

non-absorbable synthetic
including polypropylene (prolene), polyester, HDPE (high-density polyethylene), polytetrafluoroethylene
absorbable synthetic
including PLGA (poly(lactic-co-glycolic acid)), PCL (polycaprolactone)
biologic
including acellular collagen derived from cows and pigs (bovine and porcine sources, respectively)
composite
includes any combination of the above three categories.

Timeline

1950s
Surgical mesh is introduced to treat and repair abdominal hernias.
1970s
Gynecologists begin using the same surgical mesh used to repair hernias in surgeries to make abdominal repairs to pelvic organ prolapse (POP).
1990s
Gynecologists introduce surgical mesh to the treatment of stress urinary incontinence (SUI) and transvaginal repair of POP. In response to this growing trend, manufacturers begin to design and market surgical mesh products specifically for use in POP and SUI surgeries.
1996
FDA cleared the first surgical mesh designed for use in SUI surgeries.
2002
FDA clears the first surgical mesh designed specifically for use in POP surgeries.
October 20, 2008
FDA issues a Public Health Notification (PHN) and Additional Patient Information on serious complications associated with surgical mesh placed transvaginally to treat POP and SUI.
August 2009
Researchers prematurely halt their study comparing the outcomes of traditional prolapse surgery without mesh and vaginal surgery with mesh "due to predetermined stopping criteria for vaginal mesh erosion."[2]
August 2010
The study that was prematurely halted a year earlier is released in Obstetrics & Gynecology. The study's authors conclude: "At 3 months, there is a high vaginal mesh erosion rate (15.6%) with no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs."[2]
"The bottom line," lead author Dr. Cheryl B. Iglesia told The New York Times, "is not only there were more complications, but the mesh didn't prove any better than traditional surgery."[3]
July 13, 2011
The FDA updated their safety communication on surgical mesh for tranvaginal repairs to inform doctors and patients "that serious complications associated with surgical mesh for transvaginal repair are not rare."
August 3, 2011
A recall for Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE was issued by the FDA citing that "[t]he device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement."
January 3, 2012
The FDA ordered 99 postmarket surveillance studies ("522 Studies") of urogynecologic surgical mesh used transvaginally to repair POP and SUI. From the FDA: "These studies will provide the FDA, manufacturers, and health care providers with data that can inform the FDA's understanding of the safety and effectiveness profile of urogynecologic surgical mesh."
View a list of these FDA mandated surgical mesh studies.
January 4, 2012
The FDA updated their information on urogynecologic surgical mesh implants: "Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III."
June 4, 2012
Ethicon, a Johnson & Johnson company, notified the court that they were no longer going to be marketing four of their mesh products in the US:
  • GYNECARE TVT SECUR™ system,
  • GYNECARE PROSIMA™ Pelvic Floor Repair System,
  • GYNECARE PROLIFT™ Pelvic Floor Repair System, and
  • GYNECARE PROLIFT+M™ Pelvic Floor Repair System.
Ethicon's letter to the court further stated that they had "requested that FDA's Office of Surveillance and Biometrics place the existing 522 orders requiring additional studies for these products on hold."
Lana Keeton of Truth in Medicine told the Huffington Post: "These companies know they will never be able to prove safety and efficacy of these devices in the studies mandated by the FDA in January of this year."[5]

Sources
  1. Urogynecologic Surgical Mesh Implants. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm Accessed: June 27, 2012
  2. Iglesia, Cheryl B. MD; Sokol, Andrew I. MD; Sokol, Eric R. MD; Kudish, Bela I. MD; Gutman, Robert E. MD; Peterson, Joanna L. RN; Shott, Susan PhD. "Vaginal Mesh for Prolapse: A Randomized Controlled Trial," Obstetrics & Gynecology: August 2010 - Volume 116 - Issue 2, Part 1 - pp 293-303 doi: 10.1097/AOG.0b013e3181e7d7f8. [Link]
  3. Rabin, Roni Caryn. "Trial of Synthetic Mesh in Pelvic Surgery Ends Early," The New York Times. October 22, 2010. <http://www.nytimes.com/2010/10/26/health/research/26complications.html?_r=2&emc=eta1> Accessed July 6, 2012.
  4. Rockoff, Jonathan D., Wang, Shirley S. "J&J to Stop Selling Surgical Mesh." The Wall Street Journal. Accessed June 5, 2012 <http://online.wsj.com/article/SB10001424052702303506404577448422586204212.html>. Accessed: July 3, 2012.
  5. Perrone, Matthew. "Pelvic Mesh Implant Sales Halted By Johnson And Johnson," The Huffington Post. June 5, 2012. <http://www.huffingtonpost.com/2012/06/05/pelvic-mesh-implant-johnson-and-johnson-sales_n_1571309.html> Accessed July 6, 2012.

Surgical Mesh Complaints

Between January 1, 2008 and December 31, 2010:

  • 2,874 urogynecologic surgical mesh complaints were filed with the FDA. The complaints included:
    • vaginal mesh erosion (also called exposure, extrusion, or protrusion)
    • pain, including dyspareunia (painful intercourse)
    • infection
    • urinary problems
    • bleeding
    • organ perforation
    • recurrent prolapse
    • neuro-muscular problems
    • vaginal scarring/shrinking
    • emotional problems
  • 1,503 were associated with POP repairs.
  • 1,371 were assocuated with SUI repairs.
  • 7 deaths were associated with POP repairs.
  • 3 of the deaths were directly related to the mesh placement procedure (two bowel perforations and one hemorrhage).

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