Surgical mesh used to treat certain gynecological conditions is referred to as pelvic or transvaginal mesh. These products are considered medical devices, and while they have been approved by the U.S. Food and Drug Administration (FDA), they have proven to be risky for many women. Companies are facing lawsuits and are paying victims of harm caused by transvaginal mesh, and now a watchdog group in the UK is calling for all types of transvaginal and pelvic mesh to be banned.
What is Transvaginal Mesh?
Transvaginal mesh is a thin, lightweight mesh that has long been used in surgical procedures, such as hernia repair. It is inserted in the body to make a repair to damaged tissue. Mesh that is used to support pelvic organs is called pelvic or transvaginal mesh. It can be inserted through a surgical opening, or less invasively through the vagina. It is most commonly used to treat pelvic organ prolapse and stress urinary incontinence.
The use of transvaginal mesh was initially seen to be a simple, non-invasive way to treat these conditions, but many women have had serious complications after mesh was inserted. These include infections, incontinence, pain, scar tissue, bleeding, and erosion, or the movement of the mesh through healthy tissue, which can lead to damage to organs.
The FDA uses a special process, known as 510(k), to approve some medical devices without requiring the manufactures to test devices rigorously. The 510(k) process relies on the fact that many new medical devices are similar to already approved devices. The FDA allows manufacturers of these devices to get approval only by proving this similarity. This is how transvaginal mesh was approved, but critics say it should have been tested, and because it wasn’t many women have suffered.
UK May Ban Transvaginal Mesh
In the UK, the National Institute for Health and Care Excellence has spoken out about the risks mesh poses to women and has called for an outright ban of the medical device. The group says that there is insufficient evidence to prove that transvaginal mesh is effective as treatment over the long-term, and that there is adequate evidence that it can cause serious complications.
More women in the UK are treated with transvaginal mesh than in the U.S., which may be why the issue has come to the forefront in that country. While the National Health Service does not have to take the recommended ban, experts believe it will. Transvaginal mesh has already been banned in New Zealand and Australia.
Johnson & Johnson Ordered to Pay Mesh Victim
Meanwhile in the U.S. thousands of women are suing the manufacturers of transvaginal mesh. Most recently a New Jersey court ordered Johnson & Johnson to pay damages in the case of a woman who now suffers chronic pain after having the company’s Ethicon mesh implanted. The court awarded the woman $5 million for her pain and loss of consortium and ordered the company to pay an additional $10 million in punitive damages.
The case comes after investigations discovered that Johnson & Johnson knew about the risks of transvaginal mesh and failed to warn physicians. In this case the woman’s lawyers argued that there was evidence that researchers at the company had discovered serious risks of the mesh, but told doctors the risks were minimal.
Whether or not transvaginal or pelvic mesh will be banned in the UK or in the U.S. remains to be seen. The FDA currently has no plans to implement a ban. What is certain to occur, though, is that more women will be compensated through trials against companies like Johnson & Johnson.