Stress Urinary Incontinence (“SUI”) and Pelvic Organ Prolapse (“POP”) are relatively common but treatable medical conditions. In the last ten years, horrible complications associated with pelvic mesh and sling devices used in patients with SUI or POP have increased dramatically.
There are currently thousands of lawsuits against the manufacturers of these products. After years of consumers’ allegations of severe injuries, alerts from the FDA and reluctance on the part of the manufacturers to acknowledge the failings of these devices, the manufacturers have finally started settling many of the lawsuits filed against them. From 2015 to 2016, some of the biggest manufacturers have paid hundreds of millions of dollars in settlements. But the journey that has led us to this point has been a long and arduous one.
SUI is the loss of bladder control which affects many older women and women following childbirth. POP is a weakening of the muscles and ligaments that support organs like the bladder and uterus and has the potential to be very serious. Traditionally, doctors treated these conditions without mesh in a procedure called an abdominal sacrocpopexy which uses the patient’s own ligaments to support weakened muscles.
An article in the journal Obstetrics & Gynecology described a 15 percent adverse event rate of women in a clinical trial who received the mesh as compared to those who were assigned to receive the colpectomy. Many the side effects concerned “erosion” where the skin splits and the mesh protrudes, resulting in infections, pain, scarring and future surgery to remove the mesh. The study was halted mid-way because too many of the mesh patients were suffering from complications. The study concluded, “At three months, there is a high vaginal mesh erosion rate (15.6 percent) with no overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh of vaginal prolapsed repairs.”
Prior to the study, the FDA had issued a 2008 “safety alert” to physicians that vaginal mesh had been associated with complications but that the problems were “rare.” This was based upon more than one thousand adverse event reports sent to the FDA between 2005 and 2008. And in 2009, the FDA again issued a “safety alert” to warn of complications. Patients should be informed that mesh placement is permanent and advised of the potential for and nature of related complications, including erosion, infection and perforation.
On September 11, 2011, an FDA Advisory Panel recommended that vaginal mesh products be reclassified as Class III devices and that more stringent pre-market testing be required prior to approval. Class III devices must undergo full pre-market approval, which includes safety testing. To date, most mesh products had been approved under a 510(k) review process, which requires only a showing that a device is substantially similar to another device previously approved.
In the last several years, the FDA has approved over 100 vaginal mesh devices without any preclinical testing. Thus, horrible complications associated with these devices have increased dramatically. In just a three-year span, almost 3,000 adverse events were reported to the FDA. These complications include:
- Organ perforation
- Urinary incontinence
- Painful intercourse
- The need for additional surgeries.
There are many manufacturers of these products, in addition to Johnson & Johnson and C. R. Bard, including American Medical Systems, Caldera, Coloplast and Boston Scientific.
- American Medical Systems manufactures the following mesh/sling products: Apogee, Perigee, Mini-Arc Sling, Monarc Subfascial Hammock, Influence In-Fast, In-Fast Ultra, IntePro Y sling, Elevate with IntePro, Intexen, Bio-Arc and Sparc.
- Boston Scientific manufactures the following: Pinnacle, Advantage, obtryx, Lynx, Prefyx, Solyx and Posterior Uphold.
- Bard manufactures the following: Uretex, Pelvisoft, Avaulta, Pelvilace, Pelvicol, Align and Pelvitex.
- Johnson and Johnson manufactures Gynecare, Gynemesh and Prolene Mesh.
- Coloplast manufactures ARIS TOT and NovaSilk.
- Caldera Medical manufactures T-Sling and Desara.
There have been an incredibly high number of lawsuits filed by people who have suffered from the complications associated transvaginal mesh and sling medical devices. While many of these lawsuits are ongoing, several have resulted in settlements. In 2016, Johnson & Johnson agreed to pay more than $120 million to settle 2,000 to 3,000 suits over these surgical inserts, though the company still faces over 40,000 other lawsuits.
As Bloomberg reported in January of 2016, Boston Scientific had settled roughly 3,000 cases to the tune of $119 million in its first settlement in 2015. That same year, Bard paid around $200 million to settle around 3,000 cases. Both companies still have thousands of unresolved lawsuits.
Despite the high number of serious complications caused by these devices, the FDA still has not recalled them. If you or a loved one has suffered serious complications and/or additional surgery because of a transvaginal mesh or sling medical device, please contact Pogust Braslow & Millrood.