Transvaginal Mesh Erosion
Transvaginal mesh is used to treat stress urinary incontinence and pelvic organ prolapse in women. The devices, which are manufactured by various pharmaceutical companies, have been linked to serious transvaginal mesh side effects, including mesh erosion.
Vaginal mesh erosion is a common and painful side effect that occurs when the mesh migrates outside the vaginal wall, where it can cause injury to surrounding tissue and organs. Transvaginal mesh erosion is a serious complication that can be difficult to treat. In some cases, revision surgery may be needed to remove the defective mesh and address internal injuries caused by the device.
The product liability lawyers at The Sanders Firm work with women who have been injured by vaginal mesh, helping them determine whether legal compensation is possible for medical bills, lost wages and pain and suffering. If you have suffered a serious injury, such as those stemming from device erosion, due to pelvic mesh surgery, you may be eligible to join the tens of thousands of women across the country that have sued mesh manufacturers for damages. Call our personal injury attorneys today for a free and confidential consultation about your case: 1.888.972.8566.
Uses for transvaginal mesh
Vaginal mesh is a surgical mesh used to provide structural support to abdominal organs that may shift as a result of aging or childbirth. The mesh was first introduced in the 1970s as a treatment option for pelvic organ prolapse, or POP, a condition where the bladder and other organs may start to drop into the vagina, causing discomfort and other symptoms. By the 1990s, vaginal mesh was also used to treat stress urinary incontinence (SUI), a condition where urine is leaked during coughing, laughing or exercise.
Unfortunately, transvaginal mesh complications like erosion have been reported by a number of women who have been treated with these surgical devices. Boston Scientific, manufacturer of the first mesh device ProtoGen, recalled their product after receiving 123 reports of serious complications. However, this company and others continue to market other vaginal mesh products to women and the medical community.
Vaginal mesh erosion
A number of potentially serious transvaginal mesh complications have since been associated with these devices:
- Persistent pain
- Recurring infections
- Formation of abscesses
- Damage to the bowel and bladder
- Vaginal mesh erosion or extrusion
Transvaginal mesh erosion was one of the most commonly reported side effects reported to the FDA between 2008 and 2010. In 2011, the agency issued a safety communication, warning that transvaginal mesh side effects were “not rare.” The agency also noted a lack of sufficient evidence showing treatment with vaginal mesh was more effective than treating SUI or POP using traditional surgical methods.
Vaginal mesh erosion risks
The FDA issued its first safety communication involving pelvic mesh devices in 2008, after receiving more than 1,000 reports of adverse events involving nine manufacturers of the products.
The first warning was issued directly to healthcare providers and included the following recommendations:
- Specialized training for proper mesh placement
- Patient information about the permanence of the procedure
- Patient information about risks of serious complications
- Patient receipt of written label for the mesh product
- Watch for potential complications during surgery, particularly organ perforations
After that initial communication, the FDA received an additional 2,874 reports of adverse events involving vaginal mesh products between 2008 and 2011. That is when the agency issued its second safety communication, focused on consumers as well as the medical community.
In addition to the FDA reports on transvaginal mesh side effects, some studies have also confirmed a link between the devices and a higher incidence of complications after surgery.
Louisiana researchers published study results in November 2012 that found unique complications associated with vaginal mesh over other types of surgical repair for POP and SUI. Those complications included extrusion of the mesh into the vagina and erosion of the mesh into the urinary tract. The researchers also stated in their findings that these complications tended to be more serious and required revision surgery more often than other surgical treatments for these conditions.
In 2013, two studies reported in OBG Management found that native tissue is superior to transvaginal mesh for treatment of POP. Researchers from North Carolina discovered use of vaginal mesh resulted in an increased risk for revision surgery within a five-year period. Mayo Clinic researchers from Minnesota also found that native tissue repair appeared to be more effective for the majority of women undergoing treatment for POP.
Transvaginal mesh erosion symptoms
The earlier transvaginal mesh erosion is detected, the more effectively it can be treated.
Vaginal mesh erosion may include one or more of the following symptoms:
- Vaginal bleeding
- Persistent pain
- Recurring infection, including bladder infections
- Pain during intercourse
- Irritation and discomfort for partner during intercourse
- Recurrence of original condition (POP or SUI)
Treatment for transvaginal mesh side effects
Transvaginal mesh erosion can be difficult to treat, because once the surgical mesh migrates outside the vagina, it can be difficult to locate and remove completely. Initial treatment may involve administration of hormone therapy and antibiotics, but surgical removal of the mesh is often necessary to fully eliminate painful symptoms. Unfortunately, tissue can grow around the mesh, making it difficult for a surgeon to remove the entire device in a single procedure in some cases. Some women have undergone multiple transvaginal mesh revision surgeries and some never find complete relief from their symptoms.
Revision surgery can be a risky procedure as well, leaving patients vulnerable to possible bleeding, pain, discharge and organ perforation. Infection can also occur and scar tissue that develops as a result of the surgery may lead to additional pain. Removal of embedded tissue also raises the risk for other organ damage, which may require additional surgical repair.
Transvaginal mesh litigation
Some women who have been injured by transvaginal mesh complications have sought legal recourse for their injuries. As of April 2014, more than 55,000 vaginal mesh lawsuits had been filed against numerous manufacturers. Cases against seven of those companies have been coordinated into multidistrict litigation (MDL) in U.S. District Court for the Southern District of West Virginia. An MDL is established to streamline a growing number of similar cases against a single defendant to make the legal process more convenient for all parties involved.
The defective product attorneys at The Sanders Firm understand the physical and emotional trauma transvaginal mesh side effects can cause. Surrounded by a team of medical experts and experienced investigators, our lawyers work tirelessly to represent injured clients pursuing compensation for medical bills, lost wages and pain and suffering.
If you have been injured by transvaginal mesh complications, help is available. Contact The Sanders Firm at 1.888.593.3638 for a free consultation and evaluation of your case.
- FDA, FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence, http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm
- FDA, FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
- OBG Management, Native Tissue is Superior to Vaginal Mesh for Prolapse Repair, Two Studies Report, http://www.obgmanagement.com/home/article/native-tissue-is-superior-to-vaginal-mesh-for-prolapse-repair-two-studies-report/b1d2c8d22dfe70df456020f169da6fb6.html
- Bloomberg, J&J, C.R. Bard must Study Safety of Vaginal Mesh, FDA Says, http://www.bloomberg.com/news/2012-01-04/fda-orders-safety-studies-for-vaginal-implants-made-by-j-j-and-c-r-bard.html
- WBUR’s Common Health, FDA Proposes New Restrictions to Address “Health Risks” of Vaginal Mesh, http://commonhealth.wbur.org/2014/04/fda-new-restrictions-vaginal-mesh
- NCBI, Vaginal Mesh – The Controversy, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3506218/
- U.S. District Court, Southern District of West Virginia, Welcome, http://www.wvsd.uscourts.gov/
- WBUR’s Common Health, Surgery under Scrutiny: What went Wrong with Vaginal Mesh, http://commonhealth.wbur.org/2011/11/surgery-under-scrutiny-what-went-wrong-with-vaginal-mesh