FDA News Release, "FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse," April 29, 2014.
According to an FDA press release today, the FDA has proposed two orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness of surgical mesh used to treat transvaginal POP. Surgical mesh indicated for surgical treatments of stress urinary incontinence (SUI), abdominal POP repair with mesh, hernia repair, and other non-urogynecologic indications are not part of the proposed order. The public comment period on the proposed order will be open for 90 days. Read More Alerts About Transvaginal Mesh.
 FDA News Release, "FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse," April 29, 2014.
On April 10, 2014, the FDA sent a warning letter to Endo's American Medical Systems Inc. notifying the company that it would need to conduct a follow-up inspection of Endo's Minnesota plant to validate whatever corrective action has been taken since a February inspection. The issues relate to process validation, risk analysis, and procedures for corrective and preventative actions. Endo has faced extensive litigation related to its transvaginal mesh products, which have been linked to serious complications in women. Read more about pending vaginal mesh lawsuits here.
A Texas jury awarded $1.2 million in compensatory damages to plaintiff Linda Batiste in a lawsuit over Johnson & Johnson's TVT-O mesh sling, sold by its subsidiary Ethicon. The TVT-O product is a surgical mesh designed to treat pelvic organ prolapse (POP) and stress urinary incontience (SUI) in women. After a wave of lawsuits over the devices, J&J stopped selling some lines of vaginal mesh implants, but the TVT-O sling is still on the market. The jury found that the TVT-O was defectively designed, but that warnings about the risks were adequate and declined to award punitive damages. Read more about Pelvic Mesh litigation…
 Batiste v. McNabb, No. 12-14350, District Court for the 95th Judicial District, Dallas County Texas (Dallas).
 Feeley, J. "J&J Must Pay Damages in Mesh Incontinence Implant Verdict Loss," BloombergBusinessweek, April 4, 2014.
 Perriello, B. "Jury splits in $1.2M Ethicon pelvic mesh case," April 4, 2014.
The Danish company Coloplast A/S agreed to pay $16 million to settle about 400 suits over its transvaginal mesh products including the Novasilk-Synthetic Flat Mesh System and the Aris-Transobturator lines. The average payment per claimant will be about $40,000. Settlement talks continue with other manufacturers of mesh products including C.R. Bard, Endo Health Solutions Inc., and Johnson & Johnson. An estimated 1 million women have had the surgical mesh inserts during the past 15 years to help treat and pelvic organ prolapse and urinary incontinence.
 In Re: Coloplast Corp Pelvic Support System Products Liability Litigation, 12-md-2387, (U.S. District Court, Southern District of West Virginia)
 Feeley, J. "Coloplast Said to Pay $16 Million to Settle Vaginal-Mesh Suits", Bloomberg Businessweek (March 4, 2014).
Retrieved from http://www.businessweek.com/news/2014-03-04/coloplast-said-to-pay-16-million-to-settle-vaginal-mesh-suits
In a recent filing with the U.S. Securities and Exchange Commission, Endo Health Solutions Inc. reported that it is facing subpoenas by multiple states investigating its pelvic mesh products, including transvaginal mesh products designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Endo is already defending against roughly 22,000 lawsuits in federal multidistrict litigation, state, and Canadian courts that claim its vaginal mesh products are defective and have cause chronic pain, incontinence and permanent deformities. In June Endo agreed to pay $54.4 million to settle an unspecified number of vaginal mesh claims.
 U.S. Securities and Exchange Commission Form 10-K, Commission File No. 001-15989, Endo Health Solutions Inc (February 28, 2014).
Earlier this week, a West Virginia federal court magistrate found that defendant Johnson & Johnson (J&J) negligently lost or destroyed thousands of documents and computer files about the development of its vaginal mesh inserts, Gynecare Prolift and TVT Retropubic, manufactured by its Ethicon unit. Consequently, the magistrate has recommended that J&J should be punished by allowing some juries to hear about the document destruction. J&J faces more than 12,000 lawsuits over vaginal mesh inserts many of which have been consolidated in multidistrict litigation (MDL) proceedings in the Southern District of West Virginia.
 In Re Ethicon Pelvic Repair System Products Liability Litigation, 12-MD-02327, U.S. District Court, S.D. of West Virginia (Charleston).
 Feeley, J. "J&J Found to Have Improperly Destroyed Vaginal-Mesh Files (1)," Feb. 5, 2014.
Legal News: Pelvic Mesh Claims Against Endo, Boston Scientific, and Johnson & Johnson Consolidated in Multidistrict Litigation
Earlier this week the U.S. Judicial Panel on Multidistrict Litigation centralized pelvic mesh litigation involving Endo Pharmaceuticals unit American Medical Systems Holdings Inc., Boston Scientific Corp. and Johnson & Johnson, so that the cases would be presided over by a single judge experienced in medical device claims. The three cases (MDL numbers 2325, 2326, and 2327, respectively) contain about 150 total lawsuits and will be heard in the Southern District of West Virginia by U.S. District Judge Joseph R. Goodwin. In July, the FDA warned against using surgical mesh in vaginal surgeries and urged less risky methods for treating pelvic organ prolapse. Implanting the mesh can alleviate pelvic organ prolapse, but it can also lead to infections, bleeding, pain, and urinary problems.
 In re: American Medical Systems Inc., Pelvic Repair System Products Liability Litigation, case number 2:12-md-02325 (U.S. District Court, Southern District of West Virginia).
 In re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, case number 2:12-md-02326 (U.S. District Court, Southern District of West Virginia).
 In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, case number 2:12-md-02327 (U.S. District Court, Southern District of West Virginia).