Transvaginal Mesh

Transvaginal Mesh Timeline

1996:  Boston Scientific gets clearance for the first transvaginal mesh device, called ProteGen.  Even this first TVM device is cleared by the FDA through the 510(k) route, based on the predicate of a hernia sling.  The only safety study done for ProteGen was a three month rat study.

 

1998:  Johnson & Johnson gets clearance for Gynecare TVT by using Boston Scientific’s ProteGen as a predicate.  The following year, ProteGen is recalled, without any effect on J&J’s products.

 

1999:  Boston Scientific requests the FDA to recall ProteGen because of higher than expected erosion and because it isn’t functioning as intended.  Bad news for women, as a number of TVM products were cleared by the FDA based on this ProteGen model, but the FDA does nothing to check problems with these devices.

 

2008:  The FDA becomes concerned about reported complications with regard to TVM.  They suggest that surgeons obtain specialized training.  Though over 1,000 reports of complications have been reported to the FDA, it still states that complications are rare.

 

2011:  After a review of the scientific literature on TVM , the FDA updates its 2008 warning, stating that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”  The FDA also states that TVM repair is not more effective than traditional procedures to treat POP, and at the same time could pose a greater risk to women.

 

2011:  The FDA Advisory Obstetrics-Gynecology Devices Panel suggests that TVM implants be reclassified from moderate risk to high risk, which would mean that manufacturers would have to conduct studies based on human testing.

 

2012:  The FDA orders manufacturers to conduct three year studies to assess the impact of TVM on stress urinary incontinence.

 

2012:  Lawsuits are filed against Johnson & Johnson, American Medical Systems, and Boston Scientific, and are centralized in the Southern District of West Virginia.

 

2012:  C.R. Bard is found negligent in its handling of TVM, in that it didn’t properly test the products before putting them on the market.

 

2012:  Johnson & Johnson’s Ethicon unit stops selling four lines of vaginal mesh devices.