Transvaginal mesh and slings were created to help patients suffering from pelvic organ prolapse and stress urinary incontinence. Originally, surgeries for stress urinary incontinence or pelvic organ prolapse were performed abdominally by placing sutures above the bladder neck to prevent incontinence or sutures under the vaginal skin to prevent prolapse. These surgeries were widely successful in the 1970s and 1980s. However, given concerns regarding the invasive nature of the surgeries and recovery time for abdominal surgeries, manufacturers began to market the use of mesh and slings during vaginal surgery. For a more complete timeline of events, please visit the vaginal mesh timeline page.
- American Medical Systems (AMS);
- C.R. Bard, Ethicon (Johnson & Johnson subsidiary);
- Boston Scientific;
- Coloplast; and
began to market their mesh and sling products for vaginal surgery by hosting cadaver workshops. During these workshops, doctors would practice implanting the mesh and slings in cadavers. Generally, the workshops would take place over one day and gynecologist and urologist attendees would begin to implant the mesh and slings in patients over the next couple of months.
Patients began to experience terribly painful symptoms including pelvic pain, pain during intercourse (dyspareunia), urinary tract infections, vaginal bleeding and urinary retention. These symptoms were associated with mesh complications including mesh erosion, mesh exposure, mesh shrinkage/contraction and mesh migration. In many instances, patients have undergone removal surgeries to attempt to repair these conditions.
FDA Has Issued Safety Communications Regarding Adverse Events Associated with Transvaginal Mesh and Sling
- The Food and Drug Administration (FDA) reported approximately 2, 874 adverse events from January 1, 2008 until December 31, 2010. The most common adverse events for pelvic organ prolapse included erosion (35.1%), pain (31.4%), infection (16.8%), bleeding (8.2%) and dyspareunia (7.2%).
- On October 20, 2008, the FDA issued a Public Health Notification warning of serious complications associated with transvaginal placement of surgical mesh of pelvic organ prolapse and stress urinary incontinence. Specifically, the FDA noted that they had received over 1,000 reports from nine mesh manufacturers of serious complications including erosion through vaginal epithelium, infection and pain. The notification encourages physicians to obtain specialized training for each mesh placement and to be aware of the potential adverse events, especially erosion and infection.
- On July 13, 2011, the FDA issued a Safety Communication to physicians and patients stating that vaginal mesh had been associated with complications including erosion through the vaginal epithelium, infections, pain, urinary problems and bladder perforation. The FDA found that there was very little evidence to support the use of mesh in pelvic organ prolapse and an advisory panel recommended that the FDA reclassify the mesh as a “high-risk” product.
- Disturbingly, it has been reported that approximately 300,000 women have received vaginal mesh implants in the United States in 2010.
The FDA has asked mesh manufacturers including Ethicon (J&J subsidiary), C.R. Bard and AMS to conduct three years of trials on the safety and effectiveness of their products.
Johnson & Johnson and C.R. Bard have Removed Transvaginal Mesh Products from the Market
In June 2012, Johnson & Johnson’s Ethicon division announced that it would stop selling four types of mesh implants, GynecareTVTSecur™ System, GynecareProsima™ Pelvic Floor Repair System, GynecareProlift™ Pelvic Floor Repair System, and GynecareProlift+M™ Pelvic Floor Repair System, used to treat stress urinary incontinence. The company claimed that it was removing the products “in light of changing market dynamics, and is not related to safety or efficacy.” However, the timing is very coincidental in light of the FDA’s demand that the manufacturers test these products and monitor adverse event reports.
Similarly in July 2012, C.R. Bard stopped selling the AvaultaPlus Biosynthetic Support System. This was revealed after a $5.5 million verdict was obtained for a Plaintiff in California against C.R. Bard based on the AvaultaPlus Biosynthetic Support System.
Vaginal Mesh and Sling products remain a large portion of manufacturers’ profits and it has been reported that manufacturers have sold approximately $175 million worth of pelvic organ prolapse mesh and another $295 million for stress urinary incontinence in 2010.
For more information regarding transvaginal mesh lawsuits, please contact an experienced attorney at Pierce | Skrabanek. Our attorneys have handled medical device and pharmaceutical cases and are available for a free consultation. All cases are handled on a contingency basis meaning we don’t get paid until we win.
Transvaginal Mesh FAQs
In June 2012, Johnson & Johnson’s Ethicon division announced that it would stop selling four types of mesh implants, Gynecare TVT Secur™ System, GynecareProsima™ Pelvic Floor Repair System, GynecareProlift™ Pelvic Floor Repair System, and GynecareProlift+M™ Pelvic Floor Repair System, used to treat stress urinary incontinence. Similarly in July 2012, C.R. Bard stopped selling the Avaulta Plus Biosynthetic Support System.
For more information regarding transvaginal mesh lawsuits, please contact Pierce | Skrabanek or call (855) 400-4714 for a free consultation. We handle all cases on a contingency basis meaning that we don’t get paid until we win. Our lawyers have obtained millions of dollars in verdicts and settlements for clients.