Transvaginal mesh recalls have been limited compared to how much damage this surgical product has caused thousands of women. Transvaginal mesh, and the similar bladder sling, are products used to support organs and tissue in the pelvic region, such as the uterus or bladder. Women who received this mesh have suffered from erosion, organ perforation and resulting pain, infection, bleeding, and in some cases permanent damage.
There have been a few small recalls, and the U.S. Food and Drug Administration (FDA) has so far not issued recalls, but for the most part these devices remain on the market. Despite many reports of incidents, calls from consumer advocacy groups to recall them, and warnings from the FDA about safety concerns, mesh remains on the market and most products have not been recalled. If you suffered because of transvaginal mesh, know your rights and consider taking action to fight for a recall.
Uses for Transvaginal Mesh and Bladder Slings
Both transvaginal mesh and several types of bladder slings are surgical mesh, a tightly woven material used to support tissue and organs. When tissues or muscles surrounding organs become weak because of age or damage, mesh can be used to provide extra support. Two conditions often treated with mesh in women are pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
POP occurs when the tissues supporting the uterus weaken, and transvaginal mesh is placed under it to support it and hold it in place. SUI is also caused by weakening muscle and tissues, but around the bladder and urethra. It causes urinary leakages when the body experiences even a mild physical stress. Mesh is used to support the bladder, bladder neck, or urethra to prevent leakages.
Traditionally, these conditions were treated surgically. Surgical mesh would be cut down to size and inserted through an incision in the abdomen. Companies making mesh started producing transvaginal mesh and bladder slings, made from the same materials as surgical mesh, that were the right size to treat POP and SUI, and which could be inserted vaginally instead of surgically.
Problems with Mesh
Surgical mesh by itself is not inherently problematic, but the mesh that comes in transvaginal mesh kits and some bladder slings have been found to cause more complications than expected. The FDA collects reports of adverse events and for transvaginal mesh recorded thousands of complications between 2005 and 2010. These included infections, inflammation, pain, bleeding, urinary problems, incontinence, and worsening of the conditions treated with the mesh.
The most serious complications, and those that have led to some recalls and a call for wider recalls, are erosion and perforation. The mesh has been found to erode into surrounding tissues in some women. It becomes embedded there where it causes pain, infections, bleeding and other problems and must be removed surgically. In some cases of erosion, the mesh moves all the way through tissue and perforates organs, like the intestines for instance, causing painful symptoms and damage that has to be corrected surgically.
Boston Scientific and ObTape Recall
Boston Scientific was one of the earliest makers of transvaginal mesh and bladder sling products to issue voluntary recalls. The first occurred in 1999 and was a recall of the company’s ProtoGen transvaginal mesh. It was the first such product on the market from any maker and the first to give signs that there would be problems. Just three years after it came out, Boston Scientific pulled it back and issued the recall because of safety issues.
Boston Scientific also encountered problems with a bladder sling product called ObTape. This mesh, used to support the bladder or bladder neck was recalled in 2006, after three years of use. There were several problems with ObTape, including its material. It was made from a material that the FDA had previously recalled. The material was too dense and caused the mesh to erode into surrounding tissue.
In 2012 C.R. Bard, a company that makes medical devices, stopped production of its transvaginal mesh product called Avaulta Plus. A lawsuit against Bard and this product was one of the earliest legal decisions over transvaginal mesh and led to the discontinuation and recall of the product. The case came from a woman who received an Avaulta mesh implant, which eroded and cut into her colon. The damage resulted in eight surgeries and a lot of uncomfortable complications. The jury awarded her more than $5 millin.
Ethicon and Johnson & Johnson
Ethicon is a division of Johnson & Johnson that makes a number of different medical devices and products. It used to make a line of transvaginal mesh products called Gynecare, but most of them were discontinued and recalled in 2012 over the safety concerns associated with them. There are still some Gynecare products on the market, but Ethicon changed the labeling to indicate that they are not to be used vaginally, that they can only be inserted through an abdominal incision.
Individual companies have issued recalls, have faced lawsuits, and have discontinued products because of the evidence that transvaginal mesh causes harm to too many women. The FDA has taken action as well, but has stopped short of issuing any mandatory transvaginal mesh recalls. The agency’s actions began with a 2011 advisory committee convened to discuss the safety of the products.
The ultimate decision of that panel was not to recall transvaginal mesh, but to try to reclassify it as a class III medical device. Previously the product had been a class II medical device, which refers to a moderate risk when using it. By 2016 the change was made official and while not recalled, transvaginal mesh is now a class III device, categorized this way to acknowledge that it comes with high risks for harm.
Public Call for Recalls
Not everyone has been happy with the lack of an overall recall. Many patients, consumer advocates, and medical experts wanted to see the FDA issue a recall of all transvaginal mesh and to ban them as medical devices. One group spearheading the push to get rid of all transvaginal mesh products is the Public Citizen’s Health Research Group, which claims that these products present a serious and significant risk to the public.
One of the complaints from the consumer advocacy group is that none of the companies making the mesh were required to test their products rigorously. They were all approved through the FDA’s 510(k) approval process, which allows testing to be minimal if a device is similar to something already on the market. While surgical mesh wasn’t new, the way in which it was used to treat POP and SUI was, and this group argues that it should have been better tested.
If you suffered because of transvaginal mesh or a bladder sling, you know how painful and disruptive it can be. You can join groups advocating for a total recall of the mesh to help make a change and prevent other women from being harmed. You may also be able to file a lawsuit to seek compensation for the harm mesh caused you. Many others already have and some have gotten compensation. You can talk to a lawyer about your rights and your options for suing and seeking damages over transvaginal mesh.