What is Transvaginal Mesh?
Transvaginal mesh is a mesh that is constructed from plastic. It is called "transvaginal" because the mesh is inserted into the body through an incision that is made inside the vagina.
The purpose of the mesh was to fix SUI (Stress Urinary Incontinence) and POP (Pelvic Organ Prolapse). The mesh is designed to help support the vaginal walls.
Pelvic Organ Prolapse
Pelvic organ prolapse (POP) is when the muscles around the vaginal canal weaken. This weakening results in some abdominal organs such as the bladder, uterus or bowel to fall into the vagina. Transvaginal mesh is used to hold the organs up. It cradles them in a way to keep them from falling.
The mesh used to hold the organs up comes in a variety of shapes. Also where it is placed depends on the specific needs of the patient.
Stress Urinary Incontinence
Stress urinary incontinence (SUI) is the more common reason that mesh is used. SUI is when the bladder leaks urine usually when you cough sneeze or laugh. In this case, the mesh is used to hold up the urethra.
These types of surgeries usually use mesh called Bladder slings or vaginal tape.
Complications, Side Effects, and Revision Surgery
Transvaginal mesh surgery does present risks. The FDA reported in 2011 that side effects and complications are "not rare" They also indicated that this mesh is not more effective than other methods and it might expose patients to greater risk. (Footnote 1)
Some of the more severe complications include Mesh Erosion, Pain during intercourse and organ perforation. Surgery is required to repair mesh erosion and organ perforation. It is a difficult operation because the body grows into and around the mesh over time making removing it a complicated process.
Lawsuits and Verdicts:
$5.7 Million in California in 2012. The first verdict against a mesh manufacturer was in the State of California.
$3.27 Million in September 2014 in West Virginia Federal Court
$2 Million July 2013 against Bard in West Virginia Federal Court
$18 Million in November 2014 against Boston Scientific for several plaintiffs.
$11 Million verdict in 2013 in New Jersey against Ethicon.
$12.5 Million in late 2015 in a Philadelphia trial against Ethicon
$13.5 Million in Early 2016 in another case that went to trial in Philadelphia.
All of these are cases that went to a jury trial over the last several years. There are several cases set for trial around the country including a handful in Philadelphia. The Federal Court in West Virginia has also recently announced that it would be remanding cases back to some federal courts for trial.
Client Questions and Answers
General Transvaginal Mesh Questions about the Products and Initial Surgery
There are several purposes. It really does depend on why you needed the surgery in the first place. If you were suffering from Stress Urinary Incontinence (SUI), then the mesh is used to hold up or suspend the neck of the bladder. For Prolapse, the mesh may be used to fortify or strengthen the vaginal wall, so the organs do not collapse into the vaginal canal.
The surgery starts with an incision that is made in the vaginal canal. The mesh is inserted through that incision into the abdominal cavity and then positioned. Where exactly it is positioned and connected depends on which type of surgery you have and which type of mesh is used. The mesh is often anchored and attached to the pelvic bone.
The procedure can be an outpatient or inpatient or even in an office setting, typically by a urologist or gynecologist, or urogynecologist.
There are many types. There are at least 6 different manufacturers, and each one has several different product designs.
The length of the surgery varies, depending on what type of surgery is done.
Slings are made from synthetic or biologic mesh; synthetic is usually plastic, and biologic can be human tissue (your own or a donor’s) or animal tissue (cow or pig).
Side Effects and Complications Including Bladder Sling Removal Surgery
Complications can occur after the sling is inserted (for example, incontinence worsens after the surgery, painful intercourse, blood in urine, abdominal pain, chronic urinary tract infections, and inability to fully empty bladder). A doctor may recommend removing the sling as an attempt to alleviate or improve the symptoms. A revision or removal surgery is used to accomplish a few different things.
- Loosen the mesh because it is too tight
- remove the mesh because it has eroded through organs, muscle or other tissue
- revise the mesh with a partial removal or loosening
No, women do not always have the slings removed. But there was a recent study which showed that after 10 years, as many as 1 in 30 women would have the mesh removed.
There are various ways to relieve the symptoms, and it may be a minor adjustment in the placement of the sling that requires only a doctor’s office visit.
It varies on the type of modification or revision that needs to be done.
The process will vary as well, depending on the symptoms. Commonly, the mesh can be inserted too tightly and doesn’t allow for proper urine flow, and is loosened to try to improve the complication.
- Stress urinary incontinence worsens after the surgery,
- painful intercourse,
- blood in urine,
- abdominal pain,
- chronic urinary tract infections, and
- inability to fully empty bladder.
The most severe complication is the plastic material used to make the mesh can fall apart or erode, causing pieces of the mesh to migrate into the bladder or other areas. These are the most common ones, but there can be others as well.
There is always a risk when you have surgery. One common side effect is the mesh eroding, or breaking down and covered by scar tissue or infection, which makes is very complex for the doctor to remove it entirely. It may require multiple surgeries to remove, or portions of the mesh have to remain within the insertion area.
Erosion is a breakdown or disintegration of the plastic material used to create the sling. Small pieces of the mesh can be found in the bladder or other areas and cause infection. Additionally, the mesh can work it's way back through the vaginal wall muscles.
General Questions about Mesh and Implants:
A plastic strip of tape or biologic tissue is placed underneath the neck of the bladder (urethra) to relieve stress urinary incontinence.
A bladder tuck is a description of a type of surgery that helps to suspend the bladder, often by using a suture to attach it to the pelvic bone. It can refer to some TVT tape surgeries as well.
The implant is the plastic strip of mesh that is inserted and used for the bladder suspension.
This kind of sling is the same thing as a bladder tuck, but the sling is attached to the abdominal wall.
How long does a bladder sling last: This varies, depending on the type of sling used (synthetic or biologic tissue) and if there are any complications. One recent study indicated that 1 in 30 women would need their sling replaced in 10 years.
This is just another common word for bladder sling Transvaginal mesh.
The mesh is used to reposition the bladder neck (called the urethra) so that urine retention can be improved.
This mesh is specifically used for stress urinary incontinence and is used to hold up the bladder neck and reduce symptoms of SUI. It is often referred to as a bladder sling.
Mesh patches are commonly used for hernias and placed through an incision made through the abdominal wall. These are different than the products that are used for transvaginal mesh surgery.
Common Legal Questions
There are several companies involved in these lawsuits. Some have settled. Some have not. A Mesh settlement is referring to an amount of money that you might receive if you resolved your case. So if the company offered you some money and you agreed to accept it, then you would have a mesh settlement.
These cases typically take several years to get to trial and resolve. It is almost impossible to tell you how long it will take, because it depends on so many different things, such as where it is filed, which defendant, what decisions the judge makes and how crowded the court calendar is.
Where your case is filed depends on which manufacturer made the mesh that you had implanted, and where you live.
Every person who has a case has only a limited time to file a court case. There are laws that limit the amount of time you have to file. These laws are called Statutes of Limitation. You have to get
Footnote 1 source: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm