Transvaginal surgical mesh manufacturers are facing nearly 1,300 lawsuits alleging that their products caused injuries in women. Boston Scientific, C.R. Bard, Johnson & Johnson and American Medical Systems are the four manufacturers cited in transvaginal mesh lawsuits, according to attorneys familiar with the cases.
The number of lawsuits alleging that the surgical mesh was defective has risen since the Food and Drug Administration declared that adverse events and side effects from the devices were not rare, as had previously been stated. The FDA also determined the mesh patches were no more effective at repairing pelvic organ prolapse and stress urinary incontinence than traditional surgery.
Transvaginal mesh was approved by the FDA without significant testing when manufacturers compared it to other devices already on the market, such as mesh used in hernia repair. However, thousands of women who received a defective transvaginal mesh patch have complained of serious side effects, including severe pain and tissue damage when the body rejects the device.