Many women, especially those who have given birth multiple times, develop stress urinary incontinence or pelvic organ prolapse. Thousands of such women have undergone surgical placement of a TransVaginal Mesh implant to provide organ support and relieve their discomfort.
TransVaginal Mesh implants are often shaped like slings. During surgery, the implant is secured to the pubic bones. The mesh “sling” then supports and stabilizes the pelvic organs, including the bladder, urethra, uterus, vagina, small bowel, and rectum. While these mesh implants were intended to be a long-term solution, many patients have reported that their mesh implants eroded and fell apart after only a short period of time, causing serious complications.
Unfortunately, an unreasonably high number of women who have received TransVaginal Mesh implants have developed serious post-operative complications, including infection and erosion of the mesh into surrounding tissues. In such cases, the mesh has to be removed, which can require multiple surgeries. Serious secondary complications that arise when the mesh erodes include bowel and bladder damage, and recto-vaginal fistula. This leaves many women wondering, “Why did I receive a defective TransVaginal Mesh, and who is responsible?”
One theory as to why TransVaginal Mesh implants have high infection rates is because they are implanted through a woman’s vagina, which is a difficult area to adequately sterilize. The problem of mesh erosion is thought to be connected to the types of materials the mesh implants are made of. This varies across manufacturers. For example, the mesh in the Boston Scientific’s ProteGen Sling is made of woven polyester that has been treated with pressure-injected bovine collagen. An article published in the Journal of Urology in December of 1999, reported a clinical finding that the ProteGen Sling’s mesh is prone to erosion. The ProteGen Sling was recalled by the manufacturer the same month the article was published.
The term “defective” has a very specific meaning within product liability law. Manufacturers and sellers of products have a duty to ensure that all products they introduce into the marketplace are as safe as possible. A product is considered by law to be “defective” if it’s determined to be unreasonably dangerous when used as intended. When the intended use of a product carries unavoidable risks of injury, the manufacturer must adequately warn customers about the risks.
A product may be unreasonably dangerous because of its design, an error in the manufacturing process, or because its dangers were not adequately disclosed. As a result, a number of different factors can make TransVaginal mesh defective.
Each TransVaginal Mesh product is entitled to an individual judgment as to whether it is “defective” within the meaning of product liability law. Still, thousands of product liability lawsuits have been filed against multiple TransVaginal Mesh manufacturers, and millions of dollars have been paid out in legal settlements. In 2003 alone, Boston Scientific settled over 700 ProteGen Sling lawsuits.
One of the distinguishing characteristics of product liability law is that all actors involved in the chain of commerce may be held liable for injury-producing products even if they are faultless. This is called strict liability, and it makes product liability very unique among personal injury laws. For example, under a product liability theory asserted against a TransVaginal Mesh manufacturer, all that has to be shown to establish liability is that the product is defective in its design, manufacture, or marketing, and that the defect caused the plaintiff to sustain injury.
Anyone woman who has sustained a TransVaginal Mesh injury and wants to explore her legal rights should consult with an attorney who is knowledgeable about TransVaginal Mesh injuries. An attorney can discuss the status of current litigation involving particular TransVaginal Mesh products, and can assess the overall strengths and weaknesses of her individual case. However, it is important to obtain legal advice as soon as possible because the law of each state limits the time in which a product liability lawsuit may be filed