In the world of medical procedures, there's no such thing as "risk-free." Even the most routine, innocuous procedures can lead to serious complications or, sometimes, death. The challenge for health professionals and patients is to use all of the available evidence and information to balance the potential benefits of a treatment with the likelihood of risk.
Not enough women with pelvic organ prolapse or stress urinary incontinence are being given that opportunity, according to several urologists. As a result, some have to live with painful, lifelong consequences that could have been avoided if they had had all of the facts.
Pelvic organ prolapse (POP) occurs when pelvic organs, such as the bladder or rectum, bulge into or through the vagina. It can be caused in a number of ways, including childbirth, changes during menopause or from being overweight, and can lead to serious discomfort and other problems, such as difficulty urinating and painful intercourse. Women with stress urinary incontinence (SUI) leak urine when they cough, sneeze, laugh or at other times when pressure is placed on the bladder; it, too, is often caused by childbirth.
In the late 1990s, a type of surgical mesh that could be implanted through the vagina to lift and support the bladder became a standard treatment for both conditions. Mesh, usually made of plastic, was less invasive than alternative surgeries and allowed women to be treated and return home the same day.
Within a few years, the U.S. Food and Drug Administration and Health Canada began receiving alarming reports of side effects linked to mesh surgery. Some women reported extreme, debilitating pain, infection, bleeding and painful intercourse. In many women, the mesh eroded through vaginal tissues and perforated other organs. Because the mesh is considered a permanent implant that grows into a woman's tissues "like Velcro," it is very difficult to remove and many women have to live with excruciating pain for life, says Dr. Howard Fenster, a clinical professor in the department of urologic services at the University of British Columbia.
There's not a very broad awareness that these problems exist because few women are eager to go public with their personal accounts of incontinence or extreme pelvic pain following surgery. But in reality, this is an issue that affects many women.
According to data from the Canadian Institute for Health Information, more than 25,000 women underwent treatment for SUI in 2010 and 93 per cent of those involved surgical mesh. Another 5,000 women had surgery for POP and about 30 per cent involved mesh.
Health Canada says that, from 1999 to April, 2014, there were nearly 250 reports of incidents tied to vaginal mesh. The actual number of incidents is likely higher because adverse-event reporting is not mandatory for doctors or patients. Although manufacturers are supposed to tell Health Canada about adverse events, the companies will only hear about problems reported to them by doctors and patients.
In 2008, the U.S. FDA issued a warning about the risk of complications tied to mesh surgery for POP and SUI. Health Canada issued its own warning to doctors two years later and urged them to read the labels on surgical mesh products and talk to patients about possible risks. In the United States and, to a lesser extent, in Canada, women launched lawsuits against the mesh manufacturers. In September, a Texas jury ordered one manufacturer, Boston Scientific, to pay $73-million (U.S.) to a woman who suffered nerve damage and constant pain following mesh surgery to treat urinary leakage four years ago.
Since the initial 2008 advisory, the FDA has issued subsequent warnings and said that serious complications tied to pelvic organ prolapse mesh surgery are more common than previously believed. In Canada, several urologists report that because of those risks, some products have been removed from the market and mesh is used less often for POP surgery.
Mesh is still commonly used for stress urinary incontinence and many specialists say the risks of using it are lower for that procedure. But others say they continue to have reservations. They suggest mesh is still being used too widely for POP surgery and that there are growing concerns the risks of using mesh to treat incontinence may be higher than previously thought.
Dr. Chasta Bascu, a urologist based in Victoria, says there is "increasing controversy" tied to surgical mesh used for incontinence.
What's even more alarming is that with no mandatory reporting requirements or national database to track side effects, the true scope of problems tied to surgical mesh is not known.
After several years of silence on the issue, Health Canada issued a public statement in May – a few days after being questioned by The Globe and Mail about the safety of mesh products – stating it is reviewing the safety warnings on mesh products. (That review is continuing.)
In the meantime, how many women facing a decision on mesh surgery are fully informed of the potential problems and the fact there is ongoing controversy over risk?
Specialists such as Fenster and Bascu agree that surgical mesh can help many women, but fear that too many aren't getting the full story before making their decision. Fenster said he recently treated a woman who was left unable to urinate following implantation of surgical mesh. She was angry at her doctor for failing to tell her about the risks.
Finding a balanced opinion on this topic is difficult. Most of the websites recount horror stories linked to mesh surgery, while others gloss over safety concerns. And with its vague updates, Health Canada is failing to provide Canadians with definitive information.
What women need is to be able to have a frank conversation with health-care professionals who are equipped with timely research and decisive conclusions from Health Canada. Otherwise, we're denying women the ability to properly measure benefits versus risks on an extremely sensitive and potentially painful subject.