Drugs & Medical Devices
Pelvic Mesh
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FDA Public Health Notification: Serious Complications Associated with Mesh Used in Bladder and Pelvic Organ Prolapse Repairs
On October 20, 2008, the U.S. Food and Drug Administration (FDA) issued the following letter to healthcare professionals regarding serious health problems experienced by women after undergoing pelvic organ surgery where transvaginal mesh patches were used to correct bladder problems.
If you experienced complications after receiving Gynecare surgical mesh product (or other mesh product) during gynecological or pelvic organ surgery, please complete the form below for information from our lawyers about your legal rights and options.
Dear Healthcare Practitioner:
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.
Recommendations
Physicians should:
Reporting Adverse Events to FDA
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.
Know your legal options
If you experienced a serious injury after undergoing bladder or gynecological surgery that may be caused by a transvagical surgical mesh product such as Gynecare surgical mesh system, our lawyers may be able to help you to seek compensation for your injury, pain and suffering, and other money to help with bills and other expenses.
Please complete the form below for a free and confidential review of your potential lawsuit. A Weitz & Luxenberg representative will contact you as soon as possible.
see also:
Medical opinions on pelvic mesh dangers
Medical opinions on pelvic mesh dangers2012 FDA Scrutiny
Pelvic Mesh Subject of Additional FDA ScrutinyPelvic Mesh Subject of Additional FDA Scrutiny
FDA News
Transvaginal Mesh Patch Injuries | Weitz & Luxenberg AttorneysFree defective medical device lawsuit is available for women who were injured after receiving a transvaginal mesh patch during pelvic organ surgery.
