Transvaginal mesh, also known as surgical mesh, is used after a hysterectomy is performed to correct or prevent the top of the vagina from collapsing on itself. A hysterectomy is a surgical procedure which removes the uterus from the body. The impetus behind having a hysterectomy can stem from cancer of the uterus, cervix or ovaries; infections; uterine hemorrhaging; or a ruptured uterus after childbirth.
Chances of the collapse increase after undergoing a hysterectomy procedure because the support that was once provided by the uterus is gone. After the procedure, the mesh, which is made from polypropylene, is then attached to the top of the vagina and the connective tissue around the sacral bone which keeps the vagina in place. In the past, mesh used to reinforce vaginal tissues after hysterectomy has been placed into the pelvic cavity through an abdominal incision. However, more surgeons have begun to use transvaginal placement of mesh, inserting the mesh through the vagina with specialized tools which allows for the avoidance of an abdominal incision.
There are five main companies in the United States who market transvaginal mesh:
- C.R. Bard – Avaulto Support System
- Ethicon/Johnson & Johnson – Gyncare Prolift and Gynemesh Prolene
- American Medical Systems – AMS Prolapse Repair System
- Boston Scientific – Pinnacle Pelvic Floor Repair Kit
- Proxy Biomedical, Ltd. – Polyform Synthetic Mesh
In 2010, it was reported that 100,000 prolapse procedures took place with 75,000 using transvaginal mesh.
Surgical mesh has been used for internal repairs since the 1950s, when it was primarily used for hernia procedures. Twenty years later, gynecologists discovered that surgical mesh had a place in the repair of pelvic organ prolapse. During the 1990s surgical mesh was being used for the first time to do transvaginal repairs of pelvic organ prolapse and stress urinary incontinence.
In 1996, the Food and Drug Administration (FDA) approved the transvaginal mesh device which was manufactured by Boston Scientific. However, the mesh was approved without studies being conducted and without ever being implanted in a human vagina. The approval was issued by way of the FDA’s 510(k) method which allows devices to enter the market without a substantial amount of clinical testing as long as the manufacturer can show that it is similar enough to a previous device (also known as a predicate).
When the transvaginal mesh was first approved, complications from the device were thought to be few and far between. In 1999, the first recall related to safety concerns surrounding transvaginal mesh was made. As time has gone by, increased reports on possible complications have been made.
At one time, the insertion of mesh through the vagina was thought to provide benefits over other types of surgeries. However, a growing amount of evidence suggests that transvaginal mesh can cause serious health problems.
Between 2008 and 2010, over 1,500 complaints and seven deaths were reported as being attributed to transvaginal mesh which was fives times as much as reported between 2005 and 2007.
Transvaginal mesh can cause complications like:
- Genital pain
- Recurring prolapse or incontinence
- Nerve damage
- Degrading of the mesh
- Vaginal scarring
- Autoimmune problems
- Vaginal shrinkage
- Neuro-muscular problems
- Urinary retention
- Vaginal discharge
Transvaginal mesh can also cause severe complications like erosion and organ perforation.
Erosion is the process where the mesh wears through the soft internal tissues. It can be very painful and can lead to profusion where the mesh may be visible externally. This can lead to painful sexual intercourse and may make it nearly impossible to have.
Organ perforation is the penetration of the wall of a hollow organ in the body. As mesh erodes through internal tissues, it can puncture organs like the bladder, urethra, bowel or rectum.
In October 2008, the FDA released a Public Health Safety Notification that served to warn the public about complications of transvaginal mesh. Less than three years later, in July 2011, the FDA issued an update stating that the previously reported complications were not rare. In January 2012, the FDA ordered all manufacturers of transvaginal mesh to conduct after market studies.
Later in 2012, over 650 lawsuits were filed based upon claims that the mesh caused a myriad of painful injuries. The cases were then consolidated into one lawsuit by the U.S. Judicial Panel against Johnson & Johnson’s Ethicon Inc., American Medical Systems and Boston Scientific.
Johnson & Johnson has been named a defendant in more transvaginal mesh lawsuits than any other manufacturer and have been forced to pay out millions in settlements and losing verdicts.
C.R. Bard, another transvaginal mesh manufacturer, has over 10,000 cases pending but recently paid out over $200 million to settle 3,000 cases.
American Medical Systems paid over $1.5 billion to settle its cases which included over 30,000 lawsuits. The majority of the settlements came after the FDA issued a notice stating that transvaginal mesh should be reclassified as being a high-risk medical device which would result in it being subjected to greater scrutiny.
Boston Scientific has roughly 20,000 outstanding lawsuits but has settled over 6,000 lawsuits for an estimated $457 million.
If you have suffered adverse health effects as a result of a faulty medical device, it is possible that you may be entitled to compensation. Consulting with an experienced and skilled medical device attorney is the first step to receiving the justice that you deserve. Since 2004, the law firm of Jeremy Rosenthal has focused exclusively on personal injury law and makes it their priority to put your best interest first while supplying you with first class legal representation. Call (303) 825-2223 today to schedule a consultation.