1. What is Transvaginal Mesh (TVM)?
Originally designed to correct abdominal hernias, transvaginal mesh (TVM) has been used more recently to treat incontinence and pelvic organ prolapse – conditions that often affect women after a hysterectomy, menopause or childbirth.
Pelvic organ prolapse occurs when a woman’s pelvic muscles weaken, causing the bladder, rectum or uterus to drop into the vagina. Inserted vaginally or abdominally, the mesh (net-like material made either of biological or synthetic materials such as polypropylene, polyester or stainless steel) is placed below the skin to patch the abdominal hole and block pelvic organs or other tissues from being displaced.
Because mesh products were initially synthetic and designed to stay in the body indefinitely, removal of the mesh is extremely difficult. The blood vessels and tissues grow around the mesh, requiring doctors to remove it in pieces, one surgery at a time. In an effort to address the need for short term treatments, manufactures have since developed “absorbable” or “biologic” intended for temporary use.
2. There are serious complications associated with TVM
Before TVM products were implemented, the FDA did not require manufacturers to conduct studies in humans. There were approved based on the ProtoGen Sling, which was recalled in 1999. However, in October 2008, the FDA was prompted to begin studying the medical device, after receiving 1,000 reports of complications and injuries related to TVM surgeries between 2005 and 2007.
After completing the study in 2011, the FDA reveled that nearly 2,900 reports of injuries by TVM surgeries were lodged between 2008 and 2010. The agency subsequently determined that complications with the use of TVM for treatment of prolapse are not rare, and that mesh repairs are no more effective than non-mesh repairs for treating prolapse.
The FDA took its concern a step further in January 2012, stating that it will consider reclassifying TVM as a high-risk device, after studying years of scientific data. If that happens, mesh devices will be subjected to more rigorous testing, including clinical trials with humans.
3. The FDA categorizes mesh products into four categories
- Non-Absorbable Synthetic: Made of plastic or polyester, this type is intended to be a permanent implant. 50% of all mesh products approved by the FDA fall under this category.
- Absorbable Synthetic: Intended for short-term treatment. Material loses strength and degrades over time.
- Biologic : Also used for short-term treatment because products degrade over time. Products are made from cow (bovine) or pig (porcine) tissue that is specially disinfected and prepared for human implantation.
- Composite: Intended for short or long term use. The products are made from a combination of any of the above three ingredients.
Getting legal help
If you or someone you know has been injured by mesh, or considering mesh surgery, consulting an attorney who specializes in medical devices and procedures can help protect your rights and avoid costly mistakes. Use Legal Advocate Link today to find a local attorney with expertise in these types of cases today.