Today, our medical malpractice lawyers discuss a recent FDA report concerning the safety of transvaginal surgical mesh.
Surgical mesh is a metallic or polymeric screen that can be implanted inside a person’s body to reinforce soft tissue or bone where weakness exists. Surgical mesh has been used for several decades to repair abdominal hernias and, more recently, gynecologists began using surgical mesh products for transvaginal repair of pelvic organ prolapse (POP) and for surgical treatment of stress urinary incontinence (SUI).
Since that time, thousands of women have suffered serious injuries or death as a result of transvaginal mesh placement. Indeed, according to the FDA, there have been nearly 4,000 reported cases of injury, death and malfunction related to urogynecologic surgical mesh products, 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.
The FDA recently issued a warning in a report titled, “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.”
The FDA essentially found that the health risks associated transvaginal placement of surgical mesh to treat POP far outweigh any benefit from the procedure.
The FDA identified several serious safety concerns associated with transvaginally placed surgical mesh for repair of pelvic organ prolapse (POP), including:
- Approximately 10 percent of women who undergo transvaginal POP repair with mesh experience vaginal mesh erosion (also called exposure, extrusion or protrusion) within 12 months of surgery, often requiring two or three additional surgeries and continued sequelae (e.g., pain) even after mesh removal;.
- Mesh contraction, causing vaginal shortening, tightening, and/or vaginal pain;
- New onset SUI following repair with surgical mesh;
- Pain during intercourse;
- Organ perforation;
- Urinary problems
No Benefit from Transvaginal Repair of POP with Surgical Mesh
According to the FDA, transvaginal apical or posterior repair with surgical mesh does not a provide any benefit compared to traditional surgery without mesh. In other words, traditional POP repair carries far less risk to women, and provide every bit as much benefit, as compared to using transvaginally placed mesh in POP repair.
The medical malpractice attorneys at Passen & Powell have a vast amount of experience representing patients and their families in medical negligence actions, and consult with the top medical professionals in their respective fields of specialty to assist with proving each case. To speak with an attorney about a case relating to an injury from transvaginal mesh, call us at 312-527-4500 or email firstname.lastname@example.org.