Warning: Common Incontinence Treatment Found Risky - Plus Safer Alternatives
Posted May 05 2009 6:02pm
FDA warns about dangers linked to a common surgical procedure used to treat women with stress incontinence. Here’s what you need to know – plus a safer, alternative treatment option -by Colette Bouchez
If you’re one of millions of women considering surgical treatment for urinary stress incontinence listen up: One of the most common surgical solutions is under fire from the FDA – and now the target of multi-state litigation – both citing the risk of serious injuries including the erosion of vaginal tissue, chronic pain, and more
At the heart of the controversy: A type of synthetic mesh used in conjunction with a surgical procedure known as the “vaginal sling”. Here doctors use the mesh to reinforce a woman’s internal organs, lifting them in a way that reduces the risk of involuntary urine release during times of physical stress- such as sneezing, coughing or lifting a heavy object.
According to a recent statement published by the FDA, the agency has received over 1,000 medical complaints related to injuries suffered by women treated with the synthetic mesh, which is manufactured by nine different companies.
Injuries include not only vaginal issue erosion and chronic pain, but also infections, abscesses, bloody discharge, and impaired sexual functionality, with some of the women forced to undergo multiple surgeries to correct the problems created by the “mesh” surgery.
"Sling manufacturers represented this device to the FDA and physicians as effective and fit for use with patients. The FDA's recent alert supports what we have become fully aware of in the course of talking with numerous plaintiffs seriously injured by vaginal slings -- that there has been a great need for both physicians and patients to understand the symptoms and potential injuries from implantation of this type of device," explains Attorney Henry Garrard III of the Athens, Georgia law firm Blasingame, Burch, Garrard & Ashley, who currently represent the largest number of women harmed by vaginal sling injuries.
The Vaginal Sling Controversy: Who Is At Risk Pelvic organ prolapse – the repositioning of key reproductive organs involved in bladder control - affects as many as 50% of women who have given birth one or more times, reports the National Association For Continence, (NAFC). More than half of women over age 55 complain of continence problems serious enough to warrant surgery.
Certainly not all who do have it encounter complications. But according to the FDA what increases risks is the specific type of mesh material used, the size and shape of that mesh, the surgical technique used to place the mesh inside a woman’s body and any additional procedures performed at the time – including a hysterectomy. Estrogen status at the time of surgery might also make a difference.
A Safer Alternative? So far the FDA is just investigating the use of synthetic surgical mesh in this procedure but they have ssued a stern warning to both doctors and consumers about the potential for complications. It remains to be seen whether or not the mesh will be removed from the market.
But even if it is – or you want to try the surgery before any conclusions about safety are reached - there is another, some believe safer alternative to synthetic surgical mesh. It’s a biologically based material known as Sugisis Biodesign and it offers the same symptom relief – without the risk of associated problems.
According to Dr. William Porter, a uro-gynecologist at Presbyterian Hospital in Charlotte, North Carolina, the biologic materials actually work to communicate with the body thereby reducing the need for multiple surgeries and provide lasting relief for women.
Made from purified pig intestines studies also show that in doing so it also signals surrounding tissue to grow across the “sling”, thus giving the body the opportunity to repair itself.
According to the Cook Medical, who manufactures Surgisis Biodesign, over time, the graft also becomes part of the human tissue, thus allowing your own natural defense mechanisms to respond to any threat of infection – which is what appears to reduce the risk of complications.
In one recent study published in a Scandinavian journal of obstetrics and gynecology doctors form Danderyd Hospital, in Stockholm Sweden found that mesh made from porcine fibers was not associated with any adverse inflammatory responses, and appears to be a safe alternative. Similar findings were echoed in a thesis on prolapse repair published by the Karolinska Institute in Sweden.
Based on research led by Leslie Geddes, a Purdue University’s Showalter Distinguished Professor Emeritus of Bioengineering, the new biologic surgical graft material has, in fact, led to the development of an entirely new category of tissue repair and wound management options.
The Vaginal Sling Controversy: What To Do Right Now
If you have had a vaginal sling surgery and you’re feeling fine, relax. You’re probably among the many women who found success with the use of synthetic surgical mesh.
If, on the other hand, you are experiencing symptoms - including pain on intercourse, pelvic pain, recurring infection, or any sign of infection such as a bloody discharge, see your doctor immediately – do not wait. And follow the link below to report your symptoms to the FDA.
If you are considering having a vaginal sling procedure for complications related to pelvic organ prolapse, talk to a uro-gynecologist about whether or not a biological graft may be the right option for you.
To learn more about the new biodesign material, to read the FDA warning on synthetic surgical mesh, or to file a report about your experience with the mesh , try these links: