SURGICAL MESH COMPLICATIONS | INJURED BY SURGICAL MESH, TAKE ACTION!
Truth in Medicine and its' Success Stories Our most important success is when we, as patients advocates, prevent someone's life from being destroyed by the implantation of Synthetic Surgical Mesh. A huge step in that direction happened when the FDA issued the following Public Health Notification in October 2008.
U.S. FOOD AND DRUG ADMINISTRATION
October 21, 2008 * * * Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence
This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.
Nature of the Problem
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.
The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
Obtain specialized training for each mesh placement technique, and be aware of its risks.
Be vigilant for potential adverse events from the mesh, especially erosion and infection.
Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available. Additional patient information can be found on the following FDA Consumer website at:
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of surgical mesh, you should follow the reporting procedure established by your facility. We also encourage you to report adverse events related to surgical mesh that do not meet the requirements for mandatory reporting.
If you have questions about this notification, please contact the Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-276-3356, or by e-mail at firstname.lastname@example.org.
You may also leave a voice mail message at 240-276-3357 and we will return your call as soon as possible.