What is Transvaginal Mesh?
Once thought to be beneficial for women suffering from an uncomfortable pelvic organ prolapse (POP) or from stress-urinary incontinence (SUI), transvaginal mesh (TVM) has become some women's nightmare. Instead of fixing prolapses, the mesh is known to cut into internal organs and cause deadly infections. Worse yet, studies show that TVM doesn't really fix prolapse problems in the first place.
TVM is actually surgical mesh that is placed through the vagina to hold up fallen, or prolapsed, internal organs. Originally created to repair abdominal hernias, surgical mesh has been used in the United States since the 1950s. In the 1970s, gynecologists thought that the mesh could benefit their patients who suffered from fallen internal organs due to hysterectomies, childbirth and other internal traumas that caused pelvic muscles to loosen and organs to slip. They used the mesh with traditional surgical methods, inserting it through a four- to six-inch abdominal incision and sewing it to nearby ligament and tissue and affixing it to bone to hoist up fallen organs.
Transvaginal Mesh Uses
In 1996, the U.S. Food and Drug Administration (FDA) approved Boston Scientific's transvaginal mesh placement to treat stress urinary incontinence. It was the first such device that was inserted vaginally and affixed to internal tissue. The hammock-like device was supposed to support slipped organs and strengthen weakened muscles. Within a year, the company saw its ProteGen device fail in numerous patients; by 1999, the company recalled 20,000 of its devices, saying it was causing pain, discomfort and possible severe medical issues. But because of shoddy FDA rules, within a few years other medical-device companies starting making their own versions of the ProteGen. All of the newer devices were modeled after the recalled ProteGen device.
All of the transvaginal mesh products on the market today are used to repair urinary incontinence and prolapses, which result from weak pelvic floor muscles. While SUI can cause large amounts of urine to be involuntarily released from sneezing, coughing or lifting heavy things, POP causes internal organs to slip though the vagina. Prolapses are known to be very painful and possibly life-threatening if severe.
Types of Transvaginal Mesh
Today, there are several types of TVM on the market. While the TVM patch is likely the most popular type of TVM device used, there are also mini-slings, tension-free transvaginal tape and trans-obturator tape. No matter the name or shape of the device, federal regulators agree that they can be very dangerous. The FDA said there is no research showing that any of the designs repair prolapses or incontinence. Instead, federal medical-device regulators said that TVM complications are serious and could cause severe medical problems, including infection and death. TVM insertion requires a skilled surgeon's placement; however, most medical device companies do not provide the necessary training for surgeons. If not done correctly and precisely, the surgery can result in the internal organ being perforated, internal damage and life-threatening infections. Also, the bladder, rectum and uterus are known to slip even further out of place if the device is not correctly inserted.