Image source: Johnson & Johnson |
Could vaginal mesh implants be putting some people at risk?
The Johnson & Johnson pharmaceutical company is facing a in Australia over purported flaws in mesh implants used to treat stress urinary incontinence and pelvic organ prolapse.
More than 700 women are involved in the case.
Many of them claim the implants have caused debilitating pain and other complications.
The plaintiffs’ legal team has argued that Johnson & Johnson failed to rigorously test the devices and didn’t properly communicate the risks to surgeons and patients.
“[They were] overwhelmed by a tidal wave of aggressive promotion, designed to persuade both surgeons and patients of the quick, easy one operation able to resolve the particular difficulties,” senior counsel Tony Bannon told the court in his opening submissions.
Lawsuits related to urogynecologic mesh implants have also been filed against Johnson & Johnson and other manufacturers in the United States and the United Kingdom.
In one case, a woman in the United States was awarded for damages from a Johnson & Johnson mesh product.
Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are common complications of childbirth that affect many women.
SUI occurs when tissues that support the bladder and regulate the flow of urine weaken and allow urine to leak during activities such as laughing that put pressure on the bladder.
POP develops when weakened muscles and ligaments allow pelvic organs to drop from their normal position and press against the vaginal wall.
Severe cases of SUI or POP can be treated with surgery.
In some cases, urogynecologic mesh is used to reinforce weakened tissues and strengthen the surgical repairs.
“If you’re reattaching weak tissue to weak tissue, there’s a high chance that it could fail again,” Dr. Elizabeth Timbrook Brown, MPH, assistant professor of urology at MedStar Georgetown University Hospital in Washington, D.C., told Healthline.
“So that’s why mesh was created, to try to augment that repair to make it last longer,” she continued.
The majority of women who undergo surgical procedures with mesh don’t develop complications.
But some types of mesh implants have been associated with higher rates of adverse side effects than others.
“There are three different types of meshes,” Dr. Cheryl Iglesia, FACOG, section director of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, told Healthline.
“There’s the mesh that’s used for prolapse, which can be divided into transvaginal and transabdominal mesh. And then there’s the mesh that’s used for stress urinary incontinence, which is usually just a small strap of mesh. Most of the complications occur with mesh used transvaginally for prolapse,” she said.
The most common complication associated with the use of transvaginal mesh is mesh erosion.
“The mesh can work its way out to the vaginal skin and in more severe cases erode into the underlying organs, like the bowel or the bladder. When it does that, it can lead to discharge, bleeding, pain, and the need for additional surgery,” Iglesia explained.
In 2011, the Food and Drug Administration (FDA) issued an on the safety and efficacy of transvaginal mesh for POP.
It reported that serious complications from transvaginal mesh are “not rare.”
In comparison, lower rates of complications appear to be associated with transabdominal mesh.
The safety and effectiveness of full-length “multi-incision” mesh slings for SUI have also been well established, the FDA .
However, more research is needed on “mini-slings,” which might be less safe and effective than full-length alternatives.
One of the products named in lawsuits against Johnson & Johnson is a mini-sling, which was sold under the brand name of Gynecare TVT Secur between 2006 and 2012.
Mesh implants can be helpful
According to leading urogynecologic associations, mesh implants still have a role to play in the treatment of SUI and POP.
In fact, the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) and American Urogynecologic Society (AUGS) consider full-length slings to be the “.”
The American Urological Association (AUA) has also issued statements on the use of mesh for and .
While stating that certain people may benefit from repairs with mesh, the AUA emphasizes the importance of proper training for healthcare professionals and informed consent procedures.
People who are considering surgical repairs with or without mesh should speak with their doctors to learn about the potential benefits and risks of different procedures.
For example, the FDA provides a that patients should ask their providers before undergoing transvaginal repair of POP with mesh.
Those who have already undergone surgical repairs with mesh shouldn’t be concerned unless they’ve developed signs or symptoms of complications.
“If a patient has had mesh placed and is having symptoms — such as recurring urinary tract infections, pain during intercourse, pelvic pain in general, or some other notable complication — then certainly they should present to their physician to be evaluated,” Brown said.
“But if a patient has undergone a procedure and is completely asymptomatic, then they should not be concerned,” she added. “There’s nothing that says they should take the mesh out or have some sort of secondary procedure. And actually, the recommendation is currently against that if they have no symptoms.”