In spite of the fact that thousands of product liability lawsuits are pending against several medical device manufacturers over defective transvaginal mesh device, the U.S. Food and Drug Administration (FDA) has given its blessing to another type of vaginal mesh to treat pelvic organ prolapse. According to a report in Lawyers & Settlements, the FDA has taken this perturbing action even as it is considering reclassifying pelvic mesh from a moderate-risk to a high-risk device. The approved device is manufactured by startup, Caldera Medical. Transvaginal mesh lawsuits have already been filed against this company claiming its devices are defective. But, its new vaginal mesh was fast-tracked for approval.
Serious Side Effects
The testimony of patients who have received these vaginal mesh implants or slings has been heartbreaking. The mesh devices are supposed to treat conditions such as pelvic organ prolapse and stress urinary incontinence in women by shoring up pelvic muscles. But the defective devices have offered little relief and a lifetime of pain for thousands of women.
Many women, including many of our clients, have reported horrific side effects as a result of the mesh device disintegrating inside their vaginas. Women have reported erosion of the vaginal wall, chronic pain, inability to have sex and even nerve damage. Even multiple surgeries and attempts to remove the mesh device have been unsuccessful for many women.
They have been left with a lifetime of pain and disability as a result of these defective products. Many patients also failed to see the relief they sought for pelvic organ prolapse or stress urinary incontinence. In April 2015, the FDA proposed to raise transvaginal mesh risk from moderate to high.
If You Have Been Affected
If you or a loved one has experienced severe effects as the result of a defective transvaginal mesh implant, it is important that you understand your legal rights and options. You may be eligible to receive compensation for damages such as medical expenses, lost income, loss of livelihood, loss of consortium, pain and suffering and emotional distress. It is crucial that you save all bills and receipts and if possible, maintain a journal detailing your condition. Contact an experienced product liability attorney who has successfully handled vaginal mesh lawsuits.