In a three year span the FDA received more than 1,000 reports that transvaginal mesh used to treat stress urinary incontinence and pelvic organ prolapse was causing serious complications. These complaints were not specific to one brand of mesh, but from a total of nine different manufacturers. This suggested to the FDA that the problem wasn’t just the type of mesh used, but a much broader and more serious danger to women’s bodies. Most complaints stemmed from trans-vaginal implantation. In response to this flood of complaints, the FDA released a product warning.
Women reported a variety of symptoms including:
- Pelvic pain
- Discharge
- Vaginal bleeding
- Difficulty urinating or having a bowel movement
- Pain with sitting or moving
- Severe pain during sexual intercourse
On further examination, doctors found the mesh eroded through the vaginal tissues, into the bladder, urethra and rectum. Once the mesh began to erode, infection set in. For some women, the mesh rubbed on important pelvic nerves responsible for sensation and function throughout the pelvic basin. Irritation from the mesh caused inflammation, bleeding and scar tissue. Pelvic organ prolapse returned in a percentage of these women, indicating a failure of the mesh to fulfill its original purpose.
Research is ongoing to determine if some women are more likely to experience complications, if some types of mesh more dangerous than others, and if surgical technique played a role in the development of complications.
According to the FDA warning, treatments for these complications include:
- Additional surgical procedures
- Mesh removal
- Drainage of blood clots and infected abscesses
Unfortunately, we now find that that women are needing multiple surgeries to treat their mesh related complications. Permanent scarring and nerve damage mean that even with mesh removal, there continue to be complications that affect quality of life.
Report Your Complications to the FDA
Tracking these complications and reporting them is important. The FDA asks all women who are experiencing side effects from mesh contact them at 1-800-FDA-1088.
The true number of women adversely impacted needs to be understood so the FDA can adequately warn women considering this surgery.
Greg Vigna MD/JD Trusted TVM Lawyer
We are dedicated to helping women suffering the consequences of mesh implantation. You have no financial obligations to file a lawsuit against the manufacturer of your mesh. Our time is only compensated if you win your case.
Contact Dr. Vigna at 800-761-9206 or fill out our free case evaluation form. If you prefer to talk with our on-staff female Nurse Practitioner, let us know in your message and she will contact you directly. All other messages will be answered by Dr. Vigna personally.
You are not alone in your recovery.
image courtesy CDC/ Warren Jones
