Stress Urinary Incontinence and Vaginal Mesh Lawsuits

SUI symptoms, complications, treatment with transvaginal mesh - and lawsuits

Peeing when you don’t mean to is not a great situation. You’re trying to exercise or laugh at a funny television show, and suddenly you leak a little bit. There are different types of urinary incontinence, but today we are going to discuss “stress urinary incontinence,” a common health issue mainly affecting women.

What is stress urinary incontinence?

Stress urinary incontinence, also known as SUI or effort incontinence, occurs when the bladder’s muscles weaken and the urethra cannot completely close. This results in urine leakage whenever there is intra-abdominal pressure. This pressure can be created by small things such as sneezing, laughing, coughing or exercising.

The condition is fairly common after childbirth, though hormonal changes, aging, smoking or being overweight can also contribute. Men rarely develop SUI, though it can happen after prostate surgery.

What are the symptoms of stress urinary incontinence?

SUI does not cause pain; women describe it as embarrassing, isolating and inconvenient. One can imagine how mortifying it might be to pee around friends during social situations. Symptoms include the unintentional leakage of urine when:

Some women experience incontinence every time they do those activities, and some feel it just part of the time or only when their bladder is full. When this begins interfering in daily activities or causing emotional issues (depression is very common among SUI patients, and three out of four women do not seek treatment for it), patients should consult with a medical professional.

What treatment options are available for stress urinary incontinence?

There are no medications for stress urinary incontinence. Cymbalta, an antidepressant, has been prescribed for SUI in Europe, but the United States has not followed suit. The most prominent side effect is nausea, and SUI symptoms will quickly recur when the medication ceases.

Doctors will likely begin with the following.

Behavioral training

• Timing your water intake: It’s believed that caffeinated beverages like soda and coffee contribute to the severity of SUI symptoms, so your doctor might recommend you stop drinking those and focus on water. You and your doctor can work together to figure out an optimal drinking schedule.
• Pelvic floor exercises: These are more colloquially known as “Kegels,” and they strengthen your pelvic floor muscles and urinary sphincter. This can also be combined with Biofeedback, a retraining in which sensors are placed on the body and muscle activity information is “fed back” to the patient for immediate adjustment.
• Incontinence pads: Like pads for a woman’s menstrual cycle, these are intended to catch any leakage.
• Lifestyle changes: Losing weight, quitting smoking and treating any chronic cough can help SUI symptoms.
• Bladder training: Also called “toileting,” this is literally training your bladder when and when not to release urine. This is more for when a person also suffers from urge incontinence, which is a constant feeling of “I have to go right now.” By expelling urine more frequently, leakage can be reduced.

If none of those works, your physician will move to the next step of treatments.

Devices

• Pessary: This is a silicone implant designed specifically for SUI. It is shaped like a ring, has two bumps that sit on either side of the urethra, and is inserted into the vaginal canal to support weakened organs. These are mainly used for people with pelvic organ prolapse.
• Urethral inserts: This tampon-like device is inserted into the urethra and is meant for temporary bouts of heavy physical activity; patients should not wear them 24 hours a day.

Surgery

• Injectable bulking agents: These are also known as “peri/trans urethral injections.” Synthetic polysaccharides or gels are injected into the upper portion of the urethra, bulking the area and improving the sphincter’s ability to close. Injections of blood and fat have been used with limited success; GAX collagen, or “gluteraldehyde crosslinked collagen,” has proved to be best. This is noninvasive and good to consider before other surgical options, but you will need additional injections over time.
• Retropubic colposuspension: Also known as “bladder neck suspension surgery” or “the Marshall-Marchetti-Krantz (MMK) procedure,” this procedure is done laparoscopically or through a small abdominal incision. Sutures attached to bones or ligaments lift sagging tissues around the neck of the bladder or the upper portion of the urethra.
• Inflatable artificial sphincter: This is for men who develop SUI. It is an implanted balloon with a manual pump in the scrotum that replaces the function of the sphincter.
• Bladder repositioning: Sometimes a surgeon can literally lift the bladder to a more optimal position. It’s secured by a string attaching the bladder to muscle, ligament or bone.
• Bladder sling: This is the most common treatment, and there are many sub-categories to discuss. The basic idea is that transvaginal mesh, or “surgical mesh,” is implanted to create a hammock that supports the urethra. The mesh is normally synthetic, though there is biologic mesh intended to absorb into the body.
  • Transvaginal tape: Tension-free transvaginal tape, or “TVT,” positions a polypropylene mesh tape underneath the urethra and holds it in place. Complications include erosion, organ perforation, pelvic pain and more. This has led to many lawsuits because so many patients developed complications. Read more on lawsuits and complications.
  • Transobturator tape: Also called “TOT” or “Monarc,” this tape provides support under the urethra. ObTape, a popular version of this, has been the subject of many, many transvaginal mesh lawsuits.
  • Readjustable sling: This is like the other devices, but it’s attached to an implantable tensioning device under the skin in the abdominal wall. It can then be repositioned when the patient has been given local anesthesia if SUI symptoms reoccur.
  • Mini sling: This was released in 2006 by Gynecare (Johnson & Johnson) as the TVT-Secur. It was meant to fix thigh pain and bladder outlet obstruction, two common post-surgical issues with other stress urinary incontinence devices on the market. It is inserted with only a small vaginal incision as opposed to other procedures, which require two abdominal incisions as well. This device has been embroiled in litigation (possibly because one of their tests was only for five weeks and tested the device on sheep and 31 human women).
  • Needleless sling: This TOT device requires one incision for insertion and has more surface area than other slings. By doing the procedure this way, it might offer more comfort to the stress urinary incontinence patient.

Why is transvaginal mesh implanted for stress urinary incontinence?

Transvaginal mesh has long been considered a treatment for SUI because medical device companies claimed said it would extend the life of any repair. While the product originally began as a treatment for abdominal hernias, in the 1970s surgeons began using it for pelvic organ prolapse.

Then, in the 1990s, they started using it for stress urinary incontinence. Until 1996, surgeons would cut the piece of mesh for each specific patient. That year, however, the first surgical mesh kits for stress urinary incontinence was approved by the Food and Drug Administration. By inserting mesh screens into their patients, doctors could support weak and sagging muscles. Tissue was encouraged to grow around the implant, anchoring it in place.

The FDA records of adverse events via the MAUDE database (Manufacturer and User Device Experience), through which both doctors and patients can report medical outcomes. After reviewing more than 1,876 complaints in a three-year period, they noted that a significant number of women with SUI who are treated with surgical mesh experienced erosion (also called “exposure,” “extrusion” or “protrusion,” meaning the mesh was sticking out of the vaginal opening, migrating or perforating organs). Women also experienced:

After researching the complaints of those 1,876 women, the FDA concluded that:

• Patients were mostly followed for only one year, which does not help to illustrate how surgical mesh works in the long term.
• The safety and effectiveness of the mini-sling device has not been demonstrated.
• At one year post-surgery, approximately 70-80% of women reportedly experienced successful outcomes. That means 20% developed complications.
• Pain might continue after mesh removal.
• The average rate of surgical mesh erosion at one year post-surgery is approximately 2%.
• Long-term complications of surgical mesh implants for SUI are consistent with adverse events that have been reported to the FDA.
• Complications are “not rare” and are not tied to a single product brand.

There have been so many complaints and reports of adverse effects that in 2017, the FDA reclassified surgical mesh for stress urinary incontinence surgeries as a Class II medical device, which is the category associated with medium risk.

You should weigh the benefits of surgical mesh with your surgeon. The FDA provides a useful list of questions, including “Will my partner feel the mesh during intercourse?” and “If I develop complications, can you remove the mesh?” (Not all surgeons who insert mesh can remove it.) Ask for any other treatments before attempting a mesh surgery.

Life after developing stress urinary incontinence

Many women are fine after being inserted with surgical mesh. It adheres to the right area, encourages tissue growth and doesn’t cause pain. They get on with their lives and forget they even have an implant.

Other times, there are terrible complications. It can take years for issues to develop, though the average seems to be three to four years. Some women live in extreme pain and have trouble ambulating. Others injure their partners during intercourse by actually cutting them with eroding mesh.

As problems with mesh are “not rare,” many women wish they had received more information prior to surgery, especially because very often the implant cannot be entirely removed. Mesh implants encourage tissue growth, so removal can require more than one surgery or be physically impossible. Some can’t sit for more than an hour or have vaginal bleeding. They have also reported other physical issues like chronic low-back pain or thigh pain, difficulty walking, recurrent incontinence and more.

Additionally, synthetic mesh is made of plastic called “propylene,” which can harden when exposed to heat. Bodies have body heat. That transforms the implant from its original cushy state to what feels like your screen window. This is a point of contention between stress urinary incontinence patients and device companies, because the companies claim that the implant is inert, while patients report that it is not (thus becoming biologically incompatible with the body).

This is why so many women are joining together to sue medical device companies. Read more about lawsuits and complications.

How to start or join a transvaginal mesh lawsuit after treatment for stress urinary incontinence

It’s important to think about the following before starting or joining a lawsuit:

Do I need a lawyer?

This isn’t even a question — yes, and fast. Products liability lawsuits (also known as defective products) require mountains of evidence, including depositions, interviews and more. The device company, meanwhile, has millions of dollars it can use to defend itself. An experienced lawyer knows how to play the game.

How can I join a transvaginal mesh lawsuit?

Your lawyer can file a motion to transfer your case into an existing multidistrict litigation case (a federal court tool reserved for many similar plaintiffs with common questions of fact). This would save money on pretrial aspects of the case. The other option is for the Judicial Panel on Multidistrict Litigation (seven federal judges appointed to an oversight committee) to order you to transfer into an MDL.

What does being part of a lawsuit mean?

Put bluntly, you will discuss your vagina with anyone who asks, and in excruciating detail. It will likely take a few years to finish the lawsuit, and before then you will be deposed (put under oath and asked questions by opposing counsel about your health complications). If the case proceeds to trial, you might have to testify in open court. Joining a lawsuit means being patient and understanding that you might have to discuss your private problems with strangers. At the very least you will undergo independent medical examinations, which are doctors’ appointments with a medical professional chosen by the defendant.

Do I have to pay to join a mesh lawsuit?

Nope. Personal injury lawyers work on contingency, taking around a third of the proceeds, plus costs (filing, copying, etc.). That can increase if you go to trial (a normal number is 40% in that instance). Be sure to confirm fees with any lawyers you talk to about your mesh for stress urinary incontinence case.

What might I receive as compensation?

All legal fee agreements generally have a line that says “Past performance does not indicate future rewards.” All an attorney can do is provide a range of similar outcomes for the same type of case. Some cases go to trial and a jury awards damages; others settle prior to a verdict. Those settlements have reached $20 million for a single plaintiff, like the bellwether case against Ethicon (a division of Johnson & Johnson). However, other women have had their cases tossed out. All of this means that nobody can predict anything. You have to weigh that possibility when considering whether to pursue a transvaginal mesh lawsuit for your stress urinary incontinence complications.

Will joining a lawsuit hurt my surgeon?

You have to take care of yourself. Your surgeon should understand that, and if he’s experienced, he will have likely been called as a witness before. It will feel awkward, but it isn’t the surgeon’s fault; it’s the implant’s fault. Unless your doctor or surgeon acted negligently – your lawyer can help guide you on whether medical malpractice may be an additional factor in treatment of your stress urinary incontinence.

How to hire a transvaginal mesh lawyer

Before anything else, if you are experiencing pain at your implant site, talk to your surgeon. Get that sorted out first.

After that is the time to get a lawyer. Many women feel more comfortable with a female attorney, as these cases involve intimate areas. You can also start with a Google search:

“Florida defective products OR products liability attorney SUI mesh.”

This will help to filter results, since Googling “mesh implant attorney” will result in thousands of web pages. You can modify the search using your own state and the product used in your treatment for stress urinary incontinence, if you know it.

Once you read online reviews and pick a handful of prospects, arrange to speak with them in person. This will let you know whether you’re comfortable with this person and if they have the resources to help you.

Also, remember that each state has a statute of limitations (the time window in which you can file your case). Once that time is up, so is the ability to file your case. A few states only offer one year for personal injury cases, so if you have to, get any attorney to file your paperwork and then choose a new lawyer for the more complicated aspects of the case.

Products liability law is challenging. You need an experienced lawyer who can work with pending multidistrict litigation cases. If you have not met with an attorney yet, try the Enjuris directory for someone near you who can help.

More on Transvaginal Mesh Lawsuits

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