Transvaginal Mesh and Bladder Slings
On July 13, 2011, the U.S. Food & Drug Administration (“FDA”) issued an updated safety communication warning healthcare providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options. Suthers & Harper is litigating cases on behalf of women who were surgically implanted with transvaginal mesh patches or bladder slings, and have suffered from complications, including:
- Erosion of Vaginal Tissue
- Erosion of the Implanted Mesh
- Vaginal Infections
- Pain, Including Pain During Sex
- Perforations of the Bowel, Bladder or Blood Vessels
- Urinary Problems, Including Leakage of Urine
- Recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)
- Vaginal Scarring and Deformation
Many women experience what is known as Pelvic Organ Prolapse (POP), where a pelvic organ, such as your bladder, drops or prolapses from its normal spot in your lower belly and pushes against the walls of your vagina. This can occur when the muscles that hold your pelvic organs in place become weakened or stretched from childbirth or surgery. It can be uncomfortable and painful. Likewise, many women experience what is known as Stress Urinary Incontinence (SUI), which is an involuntary loss of urine that occurs during physical activity. SUI is often seen in women who have had multiple pregnancies and vaginal childbirths, and who have experienced some form of POP. Surgeries performed in an attempt to correct POP and SUI involve the implantation of transvaginal mesh patches or bladder slings made of synthetic materials, such as polypropylene.
These vaginal mesh patches and bladder slings are typically surgically implanted through the vagina using sharp surgical tools known as trocars. Even an experienced surgeon can accidentally perforate an organ in the pelvis, such as the bladder, bowel or a blood vessel, during the surgical procedure. Complications can also result if the mesh does not bond adequately with the vaginal tissue. In some cases, the mesh can work its way through the vaginal wall or epithelium, causing pain and infection and requiring additional surgery or surgeries to repair the problems.
Some of the transvaginal mesh products implanted surgically to treat POP and SUI and the manufacturers of such products include:
- Bard Avaulta, Pelvilace and Uretex, manufactured by C.R. Bard
- Gynecare Prolift and Gynemesh, manufactured by Ethicon, a division of Johnson & Johnson
- MiniArc and Sparc Sling System, manufactured by American Medical Systems (“AMS”)
- Arise and Obtryx, manufactured by Boston Scientific
The FDA was prompted to issue the updated warning after receiving more than 3,875 injury reports associated with the mesh from 2005 to 2010. The FDA had previously issued a Public Health Notification in October of 2008 due to reported adverse events. Since 2008, the number of reported adverse events increased by more than five-fold compared to the prior three years. The most frequent complications reported included vaginal mesh erosion, pain (including painful sexual intercourse), infection, organ perforation, recurrent prolapse, vaginal scarring and shrinkage, and emotional problems. Many of these complications resulted in additional hospitalizations and/or surgeries to treat the complications or to remove the mesh.
During this same time period, researchers began a controlled clinical trial for the purpose of comparing traditional vaginal prolapse surgery without mesh with vaginal surgery with mesh. In the August 2010 edition of the journal Obstetrics & Gynecology, researchers reported that scientists chose to stop the transvaginal mesh clinical trial early because more than 15% of the women in the trial who were implanted with surgical mesh suffered from vaginal mesh erosion within three months of the date of implantation. The scientists involved in the clinical trial study questioned the value of using synthetic polypropylene mesh for vaginal prolapse repairs.
Since the release of the initial FDA warning about the transvaginal mesh products, a number of transvaginal mesh lawsuits have been filed against the manufacturers of these products in various State and Federal Courts. These cases include lawsuits against C.R. Bard, Ethicon and Johnson & Johnson, American Medical Systems and Boston Scientific. In these lawsuits, the injured women have alleged that these manufacturers (a) failed to properly design the surgical mesh products; and (b) failed to adequately inform doctors and patients of the products’ risks. Transvaginal mesh complications can cause serious and permanent physical damage and deformities. Injured women have experienced physical pain from the surgical mesh complications and the attempts to correct those complications. In some cases, vaginal scarring and deformation leads to a significant decrease in a patient’s quality of life. Women and their husbands may experience emotional and psychological issues related to the mesh complications. Women who have experienced or are experiencing serious complications associated with transvaginal mesh may be able to file a lawsuit against the manufacturer to recover financial compensation for their injuries.
Many women are aware that they were surgically implanted with a mesh product, but do not know the manufacturer or model of the product. They should contact the medical records department at the hospital where the surgery occurred, provide the date (or approximate date) of their surgery, and request the “implant log” or “implant sticker.” This is a document that is placed in the patient’s chart that provides the name of the manufacturer or brand name, along with the model number and lot number for the mesh or sling that was surgically implanted.
An experienced transvaginal mesh attorney at Suthers & Harper understands the sensitive nature of these claims and the serious complications that can result from a surgical mesh product. We have the experience and the resources to handle these cases properly. If you or someone you know has experienced serious complications after being surgically implanted with transvaginal mesh patches or bladder slings, contact us online or call us on our toll free number, 1.800.320.2384, to set up a FREE consultation.