What You Need to Know About Surgical Mesh Implants
For women who have pelvic organ prolapse, mesh can be placed through the vagina in order to repair the pelvic organ prolapse (POP). FDA released a warning July 13, 2011, saying that patients who have the surgical mesh placement through the vagina to repair pelvic organ prolapse may be exposed to greater risk than other surgical options.
What you need to know:
1. FDA says there is no evidence of greater clinical benefit such as improved quality of life with the surgical placement of mesh.
2. Last year, there were about 100,000 POP repairs completed with the use of surgical mesh. About 75,000 of those were transvaginal procedures.
3. 1503 adverse event reports associated with the surgical placement of mesh used in POP from 2008 to 2010 have been reported to the FDA.
4. The most serious complications reported from the use of surgical placement of mesh include: bleeding; infections; organ perforation from surgical tools used in the mesh placement; urinary problems; mesh becoming exposed or protruding out of the vaginal tissue; and pain during sexual intercourse
5. FDA first issued a safety warning about the surgical placement of mesh because of increasing concerns about adverse events in 2008. Since this first warning, the number of adverse events has continued to increase. A review of scientific literature published between 1996 and 2010 comparing mesh surgeries to non-mesh surgeries was conducted by FDA. After this review, FDA suggested that many patients who undergo transvaginal POP repair with surgical placement of mesh are exposed to additional risks in comparison to patients who have POP repair with stitches alone.
6. An outside panel of experts in gynecology and obstetrics are meeting on September 8th-9th to further discuss the effectiveness and safety of surgical mesh placement used to treat POP and stress urinary incontinence. The panel will also discuss clinical studies that may be necessary and the risks of transvaginal POP repair.
What you need to do:
(If you have not had surgery already): FDA recommends you to ask your surgeon before surgery about all POP treatment options and understand why the surgeon may be recommending treatment of POP with mesh. Ask your surgeon about the treatment options that do no involve mesh. After surgery, continue with follow-up care after surgery and routine check-ups. If you have any complications, notify the surgeon immediately.
(For those who have had surgery): If you have already had POP surgery and do not know whether your surgeon used the surgical placement of mesh, contact your surgeon.
The law firm of Childers, Schlueter and Smith, LLC based in Atlanta, Georgia continues to review and investigate potential transvaginal mesh implant cases on behalf of women all over the United States. Initial case consults are free of charge to all victims affected by defective and dangerous transvaginal mesh implants. Please feel free to contact our firm with any questions regarding the mesh implants.
All initial inquiries are free of charge and are completely confidential. In addition, they will be handled with compassion and total discretion. Our trained transvaginal mesh implant lawyers understand what to do and how to help.
Tags: bleeding, childers, fda investigation, FDA Safety Communication, female genitalia pain, Free mesh implant review, infection, Mentor, mesh impant lawyer, mesh implant, organ perforation, pain, pain during sexual intercourse, Pelvic Organ Prolapse (POP), POP, POP Repair, Schlueter and Smith, stress urinary incontinence (SUI), transvaginal mesh implant lawsuit, Transvaginal mesh implants, Tyco, Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse, vagina surgery, vaginal bleeding, Vaginal Implant Mesh, Vaginal Mesh Complication, Vaginal Mesh Implant, Vaginal Mesh Problems, vaginal pain, vaginal tissue (erosion)
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on Monday, July 18th, 2011 at 2:21 pm and is filed under FDA Alerts Blog, News Blog.
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