Mesh products have been regularly used to repair abdominal hernias since the 1950s.

In the 1970s, gynecologists used surgical mesh products designed for abdominal hernia repair to repair prolapsed organs.

In the 1990s, gynecologists used this surgical mesh for the surgical treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

In 2007, the American College of Obstetricians and Gynecologists warned doctors that vaginal mesh and its implantation should be considered “experimental.”

“The procedures should be considered experimental and patients should consent to surgery with that understanding “said an ACOG Bulletin.

Pictured here is an abdominal hernia being repaired on the USS Bush.

All filed federal product liability lawsuits claiming injuries with transvaginal mesh or bladder slings used for repair of pelvic organ prolapse and female stress urinary incontinence are centralized. In February 2012, multidistrict litigation (MDL) cases against the mesh manufacturers began.

Lawsuits filed against Boston Scientific consolidated cases are In re C.R. Boston Scientific Pelvic Repair System Products Liability Litigation and include the following products:

• The Uphold Vaginal Support System
• The Pinnacle Pelvic Floor Repair Kit
• The Advantage Transvaginal Mid-Urethral Sling System
• The Advantage Fit System
• The Lynx Suprapubic Mid-Urethral Sling System
• The Obtryx Transobturator Mid-Urethral Sling System
• The Prefyx PPS System
• The Solyx SIS System

Boston Scientific modified the mesh used in hernia repair to be products specifically intended to correct pelvic organ prolapse and/or stress urinary incontinence. Today, Boston Scientific sells pelvic mesh “kits” which can include not only the surgical mesh, but also tissue fixation anchors and insertion tools.

Boston Scientific sought and obtained Food and Drug Administration clearance to market the Products under Section 510(k) of the Medical Device Amendment to the Federal Food, Drug, and Cosmetics Act. Section 510(k) provides for marketing of a medical device if the device is deemed “substantially equivalent” to another predicate device. Under Section 501(k), no formal review for safety or efficacy is required, and no formal review for safety or efficacy was ever conducted by Boston Scientific regarding the products.

The MDL complaint against Boston Scientific asserts :

• COUNT I: NEGLIGENCE
• COUNT II: STRICT LIABILITY – DESIGN DEFECT
• COUNT III: STRICT LIABILITY – MANUFACTURING DEFECT
• COUNT IV: STRICT LIABILITY – FAILURE TO WARN
• COUNT V: BREACH OF EXPRESS WARRANTY
• COUNT VI: BREACH OF IMPLIED WARRANTY
• COUNT VII: LOSS OF CONSORTIUM
• COUNT VIII: DISCOVERY RULE, TOLLING AND FRAUDULENT CONCEALMENT
• COUNT IX: PUNITIVE DAMAGES

Boston Scientific lost two successive federal trials November 2014.

On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market.

On November 20, 2014, a Charleston, West Virginia jury awarded $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.

The jury found that the company acted with “gross negligence.

The women in the West Virginia Obtryx sling trial were each awarded between $3.25 million to $4.25 million, plus an additional $1 million each for punitive damages. The Obtryx sling devices are implanted during stress urinary incontinence surgeries and are still on the market.