MTBard Avaulta Vaginal Mesh

As consumer groups take the Food and Drug Administration to task over its slipshod regulation of medical devices, one hastily-approved medical device proves a serious risk to women plagued by stress urinary incontinence (SUI) or pelvic organ prolapse (POP). New studies show that Avaulta vaginal mesh slings can cause women severe pain, scarring, disfigurement, the need for multiple repeat surgeries and other permanent damage.

Vaginal slings are surgically implanted to give relief to women who suffer from embarrassing and uncomfortable conditions that result from hysterectomies, multiple vaginal deliveries, aging, obesity, chronic cough, or smoking. Stress urinary incontinence (SUI) is an involuntary loss of urine during a physical activity such as coughing, sneezing, laughing, or exercising. Pelvic organ prolapse (POP) describes the collapse of pelvic organs such as the bladder, uterus, or rectal wall into the vagina, which can cause vaginal bulging, rectal leakage, or constipation.

While surgery may be necessary to alleviate the problems associated with SUI and PO. Implanted vaginal mesh slings are less invasive than surgery and sometimes can be inserted laparoscopically. They serve as a hammock to lift sagging organs and support them in their normal position in the pelvic cavity.

The Avaulta Solo Synthetic Support System is a permanent sterile mesh implant for long-term reinforcement of weakened pelvic muscles and tissues. It is made of non-absorbable monofilament polypropylene mesh. Avaulta Plus BioSynthetic Support System adds a porous, acellular (not made of cells) ultra-thin sheet of cross-linked collagen to the polypropylene mesh. The collagen layer serves as a protective barrier between mucosal tissue and the mesh, with holes for in-growth of host tissue and capillary vessels.

Not long after the Food and Drug Administration (FDA) approved vaginal mesh slings, patients began to report complications. Two products – ProteGen bladder sling and Mentor ObTape – have been removed from the market. But Avaulta’s vaginal mesh sling remains on the market, despite numerous complications reported by users of the device:

• Chronic inflammation and infection
• Extrusion of the devices
• Mesh shrinkage or disintegration
• Formation of abscesses
• Vaginal discharge, erosion, and scarring
• Perforation of bladder, bowel, or blood vessels
• Pain during sexual intercourse
• Injury to nearby organs
• Recurring SUI and POP

Treatment of these painful complications can require abscess drainage, intravenous therapy, and blood transfusion. In some cases, multiple surgeries are required to remove the mesh sling, although removal can be difficult if the mesh has disintegrated or grown into surrounding tissue. In such cases the damage is permanent.

Government Regulation

In October of 2008, the FDA issued a Public Health Notification warning of serious complications associated with use of vaginal mesh slings to repair SUI and POP, drawing upon more than 1,000 incidents of serious complications reported by nine surgical mesh manufacturers. The number of adverse events continued to climb after the warning. Nearly three years later, the FDA finally asked surgeons to consider all other treatment options before subjecting patients to the risks of vaginal mesh products such as the Avaulta Solo Synthetic Support System and the Avaulta Plus BioSynthetic Support System.

• The FDA’s October 2008 Public Health Notification reported that of the more than 1,000 reports of complications received, the most frequent complaints included erosion through vaginal tissues, infection, pain, urinary problems, and recurrence of incontinence or prolapse. Some patients reported bowel, bladder, and blood vessel perforation during insertion; others endured vaginal scarring and mesh erosion that produced considerable pain and discomfort.
  
  This FDA notification suggested that contributing factors could include the size and shape of the mesh and the mesh material. Some researchers have suggested that complications from Bard’s Avaulta vaginal mesh products stem from the synthetic mesh fabric, and/or the collagen layer added to Avaulta Plus and that these materials are not appropriate for permanent implantation in women.

• Dramatic results of a randomized controlled trial of vaginal mesh used in cases of prolapse, conducted by Cheryl B. Iglesia, MD and several colleagues, were reported in the August 2010 Journal of Obstetrics & Gynecology.  For the study, 65 women were recruited between January 2007 and August 2009, when the study was halted due to predetermined study termination criteria for vaginal mesh erosion. The researchers concluded that:
  
  At 3 months, there is a high vaginal mesh erosion rate
  (15.6%) with no difference in overall objective and
  subjective cure rates. This study questions the value of
  additive synthetic polypropylene mesh for vaginal
  prolapse repairs.

• Less than a year later, a Canadian journal published a technical update on Transvaginal Mesh Procedures for Pelvic Organ Prolapse, sounding another alarm about the efficacy and risks of Avaulta vaginal mesh slings. The article suggested that use should be considered experimental and restricted to investigative trials. Healthcare professionals were offered the following advice:
  
  Patients should undergo thorough preoperative counseling regarding (a) the potential serious adverse sequelae of
  transvaginal mesh repairs, including mesh exposure, pain,
  and dyspareunia; and (b) the limited data available
  comparing transvaginal mesh systems with traditional
  vaginal prolapse repairs...

• The FDA’s July 2011 updated Safety Communication on surgical placement of mesh to repair pelvic organ prolapse emphasized that the risk of serious complication is not rare and that other options may expose women to less risk than transvaginal mesh procedures. In addition, the FDA points out that the exposure to greater risk comes with no evidence of clinical benefit or improved quality of life. In layman’s terms the risks do not outweigh the benefit. It’s bad enough that the product causes severe complications. Now it is clear that even if it didn’t, the product doesn’t work!
  
  From 2008 to 2010, the FDA reports, five times as many adverse event complaints received involving vaginal mesh slings than were received between 2005 and 2007. It’s no wonder: In 2010, at least 100,000 POP repairs used surgical mesh – despite increasing complaints and painful conditions that required additional surgeries or hospitalization to treat complications or remove the mesh.

The FDA now recommends that health care providers:

• Recognize that, in most cases, POP can be treated successfully without mesh products such as Avaulta vaginal mesh slings.
• Bear in mind that surgical mesh is a permanent implant that puts the patient at risk for complications and further surgeries.
• Make sure patients understand the risks and benefits of POP repair with vaginal mesh slings.

Information is a powerful tool. Patients with medical problems should arm themselves with information before deciding on any treatment option. Women who are experiencing the pain and discomfort of SUI or POP should ask their doctor about treatment options, including options that do not involve mesh. Patients who don’t know if they have had insertion of vaginal mesh slings should ask their doctors and have regular checkups, especially if they experience vaginal bleeding or pelvic pain.

Many consumers regard the previously-undisclosed complications of Avaulta vaginal mesh slings as yet another problem with the FDA’s investigative and approval process. Avaulta vaginal mesh products were approved via a fast-track FDA process labeled 510(k). In the 510(k) process all a manufacturer needs to show is that the new product is “substantially equivalent” to one already legally on the market.If that showing is made, no clinical trials are required for FDA approval of the device. Unfortunately, patients who receive a device cleared by the FDA through the 510K process often act as human guinea pigs since the new devices have never been tested on humans before clinically tested for safety. 

A reputable scientific group, the Institute of Medicine, is calling for further examination of the 510(k) approval process, and for new legislation and stricter regulations regarding medical devices. The FDA announced that the agency is open to public comments on the report, and is holding public meetings throughout the summer and fall of 2011. A panel of obstetrics and gynecology experts is scheduled to lead a conference in September 2011 to discuss the balance of efficacy and risks related to vaginal mesh slings such as the Avaulta products manufactured by C. R. Bard.

The now known serious risks of Bard Avaulta vaginal mesh slings confirms that  the FDA is not a reliable watchdog of our health and safety. When medical devices have never been tested on humans, and known complications have not been disclosed, it is up to patients and consumers to gather information and make informed decisions about their own health