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Transvaginal Placement of Surgical Mesh Injury Lawyers

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The lawyers and attorneys at our firm are currently offering free case evaluations to women who were injured as a result of a procedure known as transvaginal placement of surgical mesh.  This procedure is used to treat Urinary Stress Incontinence (USI) and Pelvic Organ Prolapse (POP) in women.  In October 2008, the Food & Drug Administration (FDA) warned that transvaginal placement of surgical mesh had caused serious and painful complications in hundreds of women.  If you or someone you know experienced a complication as a result of this procedure, we urge you to contact one of the transvaginal placement of surgical mesh injury lawyers as soon as possible to protect your legal rights.

FDA Warning of Complications Related to Transvaginal Placement of Surgical Mesh

According to the 2008  FDA alert, in a three-year period, 9 surgical mesh manufacturers  submitted more than 1000 reports of complications that have included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.  The FDA said that bowel, bladder, and blood vessel perforations had also been reported. In some cases, vaginal scarring and mesh erosion  led to significant discomfort and pain, significantly decreasing the patient's quality of life.  While the number of complications reported to the FDA seems high, our transvaginal placement of surgical mesh injury lawyers believe the true number is much higher, as not all adverse events related to a medical device or procedure are reported to federal regulators.

According to the FDA, treatment of complications related to the transvaginal placement of surgical mesh are often painful and require further surgery (some for mesh removal), intravenous therapy, blood transfusion, or hematoma/abscess drainage. Our transvaginal placement of surgical mesh injury lawyers know the devastating toll these complications take on patients, and we will work hard to make sure that victims of this procedure receive the compensation they deserve.

In its health alert  the  FDA said that  specific characteristics of patients at increased risk for such complications had not been determined. The agency said that contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.

The transvaginal placement of surgical mesh injury lawyers at our firm believe that the poor design of the mesh plays a large role in many complications related to the procedure.  If the mesh used does not allow surrounding tissue to receive nutrients and oxygen, healing will be  impaired, which can lead to the types of injuries described by the FDA.  One particular type of surgical mesh, the Mentor ObTape Vaginal Sling, had such a design defect, and was removed from the market in 2006, because of its high complication rate.

Stress Urinary Incontinence and Pelvic Organ Prolapse

Around 13 million women suffer from Stress Urinary Incontinence (SUI), an embarrassing lost of bladder control.  SUI  is caused by weak muscle tone that can result from child birth, old age and other conditions. This disorder can have a huge impact on a woman's quality of life, and it  is not surprising that women afflicted with this condition would be anxious for an effective treatment.

In Pelvic Organ Prolapse (POP), the vagina and the organs that surround and support it fall from their normal position. Many women develop vaginal prolapse, usually following menopause, childbirth or a hysterectomy. One in 11 women will require surgery for pelvic organ prolapse in their lifetime.

Symptoms of POP include pressure in the vagina or pelvis; a lump or bulge at the opening of the vagina; and urinary, bowel and sexual dysfunction.  This condition is extremely painful, and again, it is not surprising that a victim would be desperate for a treatment that could put an end to her pain.

Transvaginal placement of surgical mesh promised to be that treatment.  This procedure is meant to eliminate the symptoms of both POP and SUI by allowing the mesh to act as a hammock to support the affected organs.  In many cases the procedure works.  But when complications occur, the results are devastating.  In many instances, victims are left in much worse shape than they had been prior to the procedure.

Poor Design of Surgical Mesh

Often, the design of the surgical mesh is to blame for the complications that follow the transvaginal placement of surgical mesh.  That was the case with the Mentor ObTape Vaginal Sling, a type of surgical mesh removed from the market in 2006.  Shortly after it was put on the market in 2003,  women began reporting adverse reactions to the device including impaired healing, vaginal extrusion and urinary tract erosion that manifested itself in extreme vaginal pain, vaginal discharge, and infections. An extremely high 17 to 18 percent of women who had the Mentor ObTape Vaginal Sling implanted experienced such complications. 

In 2006, the Journal of Urology published a study that examined an unusually high number of complications caused by  the Mentor ObTape Vaginal Sling. The study looked at  67 women who had been implanted with the device, and found that more than 13 percent developed vaginal extrusions. Another eight developed a chronic vaginal discharge, and one patient developed an abscess of the left thigh that tracked to the incision site.

It has since been determined that the defective design of the Mentor ObTape Vaginal Sling blocked much needed oxygen and nutrients from reaching surrounding tissue.    Our transvaginal placement of surgical mesh injury lawyers believe that other surgical mesh products have similar design flaws.

Surgeon Error

Even when the surgical mesh used in this procedure is well designed, surgeon error may also result in complications from the transvaginal placement of surgical mesh.  For this reason, the FDA recommended in its 2008 health alert that  clinicians receive specialized training for the transvaginal placement of mesh products.  To avoid serious complications, the FDA also advised physicians to:

• Be vigilant for potential adverse events from the mesh, especially erosion and infection.
• Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
• Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
• Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
• Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

Legal Help for Victims of Transvaginal Placement of Surgical Mesh Injuries

If you or a loved one has experienced the painful complications so often associated with the transvaginal placement of surgical mesh,  you may be entitled to compensation.  For a free evaluation of your case, please contact our experienced  transvaginal placement of surgical mesh injury lawyers by filling out our online form, or by calling 1-800-LAW-INFO (1-800-529-4636).