Transvaginal and Hernia Mesh May Lead to Serious Injuries Transvaginal mesh is used in the treatment of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). Both SUI and POP are conditions typically seen in women who are middle-aged and who have given birth. Pregnancy impacts muscles and other abdominal tissues that are meant to hold the body’s organs in place. These muscles and tissues weaken as women age, typically due to the prior stress associated with pregnancy and carrying babies full-term. Weakening may cause the female body’s internal organs to begin to sag, pressing against the uterus.
Stress urinary incontinence is the involuntary release of urine during normal, everyday activities such as sneezing or laughing. Pelvic organ prolapse occurs when the organs of the pelvis prolapse, or drop, from their intended location and bulge into the vagina.
Traditional treatments involve creating a sling to treat POP and SUI, using a woman’s own tissue during invasive surgery. The use of surgical mesh laparoscopically has more recently been used in POP, SUI, and abdominal repair. Transvaginal mesh has led to complications similar to those seen with abdominal surgical mesh.
The Sunday Star-Times of Auckland in Australia reported earlier this month about the death of a Kiwi, Australia grandmother who died three years ago in Southern Cross Hospital at Invercargill, Australia after she underwent surgery to remove abdominal mesh originally used for a hernia repair. The Star-Times noted that the woman was soon doubled-over in pain following the implant surgery and lost feeling in both legs. She was prescribed opioid painkillers; however, her pain did not improve. An internal scan revealed that a large sheath of the abdominal mesh was jabbing into the woman’s internal organs. Victims of transvaginal mesh side effects describe similar adverse events as the edges of transvaginal mesh become intertwined with internal tissues and organs, or push up against the vaginal wall and-in some cases-protrude through the vaginal wall. This causes significant pain and potential infection for the transvaginal mesh recipient and makes sex nearly impossible.
The woman returned to the hospital to have the mesh removed and survived the surgery, dying in the middle of the night due to cardiac arrest and polypharmacy (the effects of taking multiple medications concurrently). Her family believes the surgical mesh led to their mother’s death and is calling for an inquiry.
Urogynecologist and professor emeritus, Don Wilson, pointed out in the report that he petitioned for a registry of mesh implants in 2014, which is the same year the woman died. He also called for a mandate for surgeons using abdominal and transvaginal mesh products to be trained and credentialed. “I wrote my submission asking for a register three years ago,” he told the Star-Times. “It’s frustrating that there’s not been more action taken.”
In Australia, there are calls for a Senate Inquiry on transvaginal mesh side effects. Joanne Boon, who serves as an administrator for an online support group notes there were 39 members when she joined two years ago and, as of June 2017, there are a total of 850 members, according to the Star-Times. Boon herself was treated for her POP with a transvaginal mesh sling in 2012. She had the mesh removed in 2015; however, the complications tied to her transvaginal mesh removal were too difficult to be handled in Australia. She sold her home to fund her trip to the United States with her 10-year-old daughter where she underwent a six-hour operation to have the transvaginal mesh removed.
The transvaginal mesh lawyers at Parker Waichman LLP are well versed in transvaginal mesh litigation. The firm, which has decades of experience in medical device litigation, continues to offer free legal consultations to individuals with questions about filing a transvaginal mesh lawsuit.
Transvaginal Mesh Background
Pelvic mesh is designed to reinforce the strength of the pelvic walls and counteract sagging organs and has become increasingly controversial in recent years over safety concerns given the thousands of transvaginal mesh lawsuits filed against various mesh makers, including Boston Scientific and Johnson & Johnson. Pelvic mesh injury reports have added to safety concerns and women have similarly alleged that transvaginal mesh implants caused them serious, often permanent injuries.
Parker Waichman LLP represents numerous individuals in the transvaginal mesh litigation. If you or someone you know suffered complications related to pelvic mesh implants, please contact our firm today for more information about your legal rights.
Numerous lawsuits point out that transvaginal mesh implants were not clinically tested for safety or efficacy before they were sold and implanted in thousands of women. This is because the devices were approved through the 510(k) clearance route, which enables manufacturers to forego the need for such testing if they are able to prove that the new device is “substantially equivalent” to an older, approved product. Device makers previously obtained transvaginal mesh approval through this fast-track review process that clears devices without clinical testing. The 510(k) process is in contrast to the agency’s pre-market approval (PMA) process, a route that mandates clinical data. Transvaginal mesh has since been reclassified from “moderate-risk” to “high-risk,” meaning the products may no longer be approved through the 510(k); they must be cleared through the stricter PMA route.
Women allege that transvaginal mesh caused injuries, including mesh erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. In 2008, the FDA indicated that the most common transvaginal mesh complications include mesh erosion, infection, pain, urinary problems, recurrence of prolapse, and incontinence. Also, according to the FDA, women have reported bowel, bladder, and blood vessel perforation.
The FDA initially indicated that transvaginal mesh complications were serious, but rare. The FDA updated this communication in 2011, clarifying that transvaginal mesh complications are, in fact, “not rare” and pointed out that there was inadequate evidence to support the use of transvaginal mesh over non-mesh methods for treating POP and that mesh inserts may pose additional risks.
Filing a Transvaginal Mesh Lawsuit
If you or someone you know suffered injuries related to the use of transvaginal mesh implants, you may have valuable legal rights. Our transvaginal mesh lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).