On April 16, 2019, the Food and Drug Administration (FDA) halted the sale of pelvic mesh over concerns for the safety of the medical device. This comes after years of complaints from consumers that the mesh was causing pain, bleeding, and scarring. The FDA acted after a safety hearing in February where mesh manufacturers Boston Scientific Corp. and Coloplast Corp. couldn’t demonstrate that the devices were safer than surgery without their use.
What is Pelvic Mesh?
Pelvic mesh is a medical device that is used to provide extra support when a doctor is repairing weakened or damaged tissue. The mesh is usually made from synthetic material or animal tissue. Surgical mesh is used to treat pelvic organ prolapse. Pelvic organ prolapse occurs when a woman’s pelvic organs slip out of place because the ligaments and muscles supporting them weaken. The mesh can be implanted to strengthen the pelvic walls and keep the organs in place. Pelvic mesh can also be used for the treatment of stress urinary incontinence which is the unintentional leaking of urine during movement or physical activity. Surgical mesh is used to hold the bladder neck or urethra in place. The mesh is inserted through a woman’s vagina instead of through surgical incisions.
Safety Concerns With Pelvic Mesh
There has been clear evidence for years that pelvic mesh was unsafe. In 2016, the FDA classified mesh to repair pelvic organ prolapse from a moderate-risk device to a high-risk device. Research found that a number of complications can arise due to the use of the mesh including:
- Mesh erosion
- Extreme pain in the pelvic region
- Organ perforation
- Urinary problems
Many women experienced long-term problems as a result of surgical mesh.
Manufacturers of medical devices have a responsibility to adequately test their products and make sure they are safe for consumers. This is especially true for medical devices that can have a major effect on a patient’s health,
Contact an Experienced Product Liability Attorney
If you’ve been injured by surgical mesh, you should have an experienced product liability attorney evaluate your case. At Bonina & Bonina, P.C., we have over 50 years of experience helping New Yorkers injured by defective medical devices. Contact us online or call us at 1-888-MEDLAW1 to schedule your free consultation. Home and hospital visits are available. Se habla español