On Monday, the Food and Drug Administration announced that it was tightening restrictions for a product used to repair Pelvic Organ Prolapse (POP). The product, a vaginal mesh, has been linked to multiple reports of harmful side effects, such as nerve damage and bleeding.
POP happens when the walls of the uterus or vagina weken, stretch, or tear, usually after childbirth, and can no longer support the internal organs, which protrude into the vagina, creating an uncomfortable feeling.
The surgical mesh will be reclassified as a device from class II, moderate risk, to a device from class III, high-risk. While the FDA is reclassifying this surgical mesh for use with POP, the agency is not applying this new classification to other indications, such as stress urinary incontinence or abdominal repair. These devices have been in use since the middle of the 20th century, when surgeons used them to repair abdominal hernias.
The mesh kits were made available through an expedited review in which the makers only need to prove that the product is substantially similar to ones already being sold. Manufacturers that have products on the market have two and a half years to comply with new the data requirements, including data on the safety and effectiveness.
These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.
This new classification comes after over 100,000 lawsuits have been filed against the companies who make these products, including Boston Scientific Corp, C.R. Bard, Johnson & Johnson, and Endo International PLC. Last year, Boston Scientific Corps settled a few thousand cases for $119 million, while Endo International PLC settled 20,000 lawsuits for $830 million in 2014. Johnson & Johnson stopped selling mesh products in 2012 for reasons unrelated to the lawsuits, a company spokesman said.