Synthetic Vaginal Mesh: Questions and Answers
Recently, the FDA issued its second warning since 2008 about the placement of synthetic vaginal mesh for the treatment of pelvic organ prolapse (POP). Please know that the section of Urogynecology at BIDMC does not routinely place synthetic mesh via the vaginal route for the treatment of pelvic organ prolapse. However, the FDA warning has stirred up some cause for concern so we’d like to take the time to answer some common questions our patients may have.
If you still have questions after reading the below Q&A, please feel free to call us at 617-667-4070.
Question:
I heard the FDA has placed a warning against synthetic vaginal mesh. I’m not sure if that was used in my pelvic organ prolapse procedure. What should I do?
Answer:
In most cases, synthetic vaginal mesh does not cause any complications. Mesh complications can include mesh erosion, pain, infection, bleeding, painful sexual intercourse, organ perforation, and urinary problems. For patients who have had vaginal mesh surgery for pelvic organ prolapse and are satisfied with their surgery and are not having complications or symptoms, there is no need to take any action other than routine check-ups and follow-up care. Patients with complications or symptoms after surgery should notify their health care provider. If you’re still concerned and not sure if your doctor used a mesh or do not know what kind of mesh was used in your repair, feel free to call the health care provider who performed your procedure to get more information.
Question:
I have had surgery for pelvic organ prolapse. Was synthetic vaginal mesh used in my procedure?
Answer:
Urogynecologists at BIDMC do not routinely place synthetic mesh via the vaginal route for the treatment of pelvic organ prolapse.
1 If your surgery to repair pelvic organ prolapse was performed via the vaginal route, and graft was used, most likely biologic grafts would have been used. The biologic grafts used are made up of Porcine Dermis (pig skin) or fetal bovine pericardium (heart lining of a baby cow), and have not been associated with high complication rates. These grafts are not implicated in the recent FDA warning.
2 If you had robotic surgery that involved the use of mesh, you most likely had synthetic mesh placed, however when placed robotically, it has not been associated with high complication rates, and is not implicated in the recent FDA warning.
Question:
I have had a procedure for pelvic organ prolapse at another hospital and I know for sure that synthetic vaginal mesh was placed. Can this be reversed? Should I have a procedure to correct it?
Answer:
For patients who have had vaginal mesh surgery for pelvic organ prolapse and are satisfied with their surgery and are not having complications or symptoms, there is no need to take any action other than routine check-ups and follow-up care. Patients with complications or symptoms after surgery should notify their health care provider. Only in certain cases is removal of the mesh necessary. There are other conservative treatments that can help alleviate symptoms depending on what your symptoms are.
Question:
I was recently diagnosed with pelvic organ prolapse and my doctor mentioned synthetic vaginal mesh as a treatment option. What should I do?
Answer:
There are many treatment options for pelvic organ prolapse. BIDMC Urogynecologists thoroughly inform our patients about the benefits and risks of ALL potential treatment options. They include non-surgical options, non-mesh surgery (i.e. native tissue or biologic graft vaginal repairs), abdominal or laparoscopic mesh procedures and transvaginal mesh placement. No one approach has proven to be superior in all cases. Our surgeons have undergone training specific to each procedure and have experience with pelvic reconstructive surgery and a thorough understanding of the relevant pelvic anatomy. We will discuss with you all your options and recommend the procedure that best meets your needs.
Question:
I had a sling placed for urinary incontinence. Isn’t that a mesh? Should I be concerned?
Answer:
The suburethral sling can be made of synthetic material (polypropylene) however is not implicated in the recent FDA warning. The FDA warning is specifically referring to large pieces of synthetic mesh used for transvaginal pelvic organ prolapse repair.
