(Defective Devices) TVM

Advances in medicine have led to great strides in the treatment or control of health conditions. More people can now lead quality lives with medical procedures performed to control conditions they are suffering from. For years, women with pelvic organ prolapse or urinary incontinence would shy away from society due to their condition. The introduction of transvaginal mesh (TVM) as a treatment option enables women to deal with their conditions and reassert themselves in society. However, greed amongst the manufacturers has led to the marketing and use of an otherwise defective product whose risks outweigh the benefits.

Currently, many manufacturers and distributors of transvaginal mesh are facing mass tort lawsuits due to the production and distribution of TVM without alerting consumers or doctors about the dangerous side effects of using the device. Some of these manufacturers have used dangerous materials in the manufacture of transvaginal mesh, with the knowledge that these materials are dangerous to the human body, and have released their products without any testing or warning about their effects.

Manufacturers have failed women by failing to conduct the right testing procedures on their devices before releasing them to the market. They have instead downplayed the risks and complications resulting from their use by aggressive marketing campaigns touting the benefits of their products such as transvaginal mesh. Consumer Alert Now is a nationwide watchdog for dangerous drugs and defective devices that will help you seek justice by joining a mass tort.

What Is Transvaginal Mesh (TVM)?

Transvaginal mesh is a mesh-like implant device used in the treatment and control of urinary incontinence and pelvic organ prolapse. TVM provides additional support to the weakened or damaged tissues of the pelvic region. Women pelvic muscles and connective tissues experience much abdominal pressure. Experiences such as pregnancy, labor, and childbirth stretch those muscles and tissues of the pelvic region and can result in weakness. When these muscles are weak, the surrounding organs may prolapse. Where the connective tissues of the bladder are affected, incontinence occurs.

The use of surgical mesh began in the 1950s as a treatment for hernia. A hernia is a condition where tissues in the abdomen or groin protrude through the abdominal wall. Previously, doctors treated pelvic organ prolapse using tissue derived from the body of the woman. However, such tissues provided a short-term solution in most cases. The use of mesh as a treatment for pelvic organ prolapse began in the 1970s where the doctors inserted the mesh via the abdomen.

The doctor would make an incision through the abdominal wall from which he or she would provide support to the affected organs. Abdominal surgeries took longer to heal, leading to the development of transvaginal surgery to insert the mesh in the 1990s. Transvaginal surgery is minimally invasive and has a shorter recovery period. FDA approved the first pelvic mesh for stress urinary incontinence in 1996 and for pelvic organ prolapse in 2002. The approval of TVM happened based on the outcomes of using the mesh for a hernia. However, additional testing was required before approving the mesh for the treatment of prolapse.

The transvaginal mesh comes in the following four different types:

• Non-absorbable synthetic mesh made from synthetic materials - The most commonly used material in this type of mesh is polypropylene.
• Absorbable synthetic mesh made from biodegradable material that eventually gets reabsorbed into the body - Absorbable synthetic mesh blends with the tissue of the surrounding cells and forms new and stronger tissue that supports the pelvic organs. The most common materials for absorbable synthetic mesh include polycaprolactone and polyglactin.
• Biological mesh made from animal tissue - Manufacturers first process and disinfect animal tissue before releasing it for use. Once inserted into the body, it begins degrading and blends with the tissues of the pelvis to form new and stronger tissues. Biological tissue comes from bovine and porcine tissues.
• Composite mesh combines absorbable and non-absorbable mesh - The most common combination features the non-absorbable synthetic mesh coated with biological mesh.

FDA 510 (k) Process

The FDA approves transvaginal mesh through the premarket or 510 (k) process. The process involves approving a product that is equivalent to a product in the market. This approval process does not allow rigorous testing of the approved devices to check them for safety and efficacy before releasing them into the market.

For device manufacturers, the 510 (k) process provides them with a cheaper way of getting products into the market as long as they are “equivalent” to earlier pre-approved models. Such a procedure has become the problem that has resulted in numerous women becoming the test samples for device manufacturers who concealed the safety issues with their products.

In the case of transvaginal mesh, the realization by the FDA that the device was in fact, harmful to the hundreds of thousands of women using it, the device had been in circulation for seven years. In 2011, the FDA ordered research to determine the safety of the mesh and ordered a reclassification. By the time the FDA issued the first high risk warning on TVM in 2016, much damage had occurred.

How TVM Works

If you are suffering from urinary incontinence or pelvic prolapse, your doctor may use the transvaginal mesh for treatment. You will go through surgery to insert the mesh. The doctor inserts the mesh through an incision in the vagina or abdomen through the following three procedures:

• Sacrohysteropexy: In this procedure, the doctor attaches one end of the mesh to the cervix and the other end to the spine, to hold the uterus.
• Sacrocolpopexy: This procedure supports the vagina and keeps it from collapsing. The doctor attached one end of the mesh onto the top of the vagina.
• Infracoccygeal sacropexy: here, the doctor inserts the mesh though the buttocks and through the back of the vagina.

Once inserted, the transvaginal mesh provides support to your pelvic organs. When in the body, tissue growth around the mesh results in the creation of a protective wall that provides long-term support to the weakened pelvic tissues.

Transvaginal mesh treats the following conditions.

• Stress urinary incontinence (SUI)

When pressure on the bladder causes you to release urine involuntarily, you have stress urinary incontinence. Stress urinary incontinence affects pre-menopausal women and those who have had one or more vaginal births. SUI occurs from sudden pressure such as coughing, sneezing, laughing, exercising, standing, bending, or walking. The severity can range from mild to severe. Women suffering from SUI may isolate themselves from feelings of fear or embarrassment should urine leak in public.

SUI occurs when the muscles of the pelvic floor weaken and cannot support the bladder and urethra. Doctors use a transvaginal mesh to provide support to the urethra and bladder. Once the mesh is in place, it embeds into the bordering tissues and forms a supportive wall. In successful surgeries, transvaginal mesh permanently treats incontinence.

• Pelvic organ prolapse (POP)

POP occurs when organs within the pelvic region such as the bladder, uterus, vagina, small bowel, and the rectum descent into or outside the vaginal or anal canals. POP occurs in most women due to pregnancy, labor, childbirth, obesity, chronic coughing, and constipation, cancers in the pelvic region, hysterectomy, and genetics. The likelihood of developing POP in older women increases due to the weakening of connective tissues holding the pelvic organs in their place.

TVM Manufacturers and Brands

1. Johnson & Johnson (Ethicon)

Ethicon is a subsidiary of Johnson & Johnson responsible for the manufacture of surgical medical devices, including products for female pelvic surgery. Their transvaginal mesh brands include:

• Ethicon TVT
• Gynecare TVT
• Gynemesh PS
• Prolene Polypropylene mesh patch

Some of their discontinued products include Gynecare Prolift, Gynecare Prolift + M, Gynecare TVT security system, and Gynecare Prosima Pelvic Floor Repair System

2. R Bard

Bard is a manufacturer, distributor, and marketer of medical products for the treatment of female pelvic health problems. Some of their products include:

• Avaulta Plus™ Biosynthetic Support System
• Pelvicol Tissue
• Avaulta Solo Synthetic Support System
• PelviSoft Biomesh
• Faslata allograft
• Pelvitex Polypropylene Mesh

Bard's products have been the subject of several lawsuits due to their complications such as nerve damage, organ perforation, and infections resulting from the use of its brands. Currently, Avaulta products are no longer in the market.

3. Endo/American Medical Systems

The American Medical Systems sold to other manufacturers after legal battles in 2011. Some of their transvaginal mesh products include Apogee vault suspension system, apogee pelvic floor systems, bio-arc cling system, in-fast ultra-transvaginal sling, perigee system, and SPARC transvaginal products.

After the acquisition, Endo no longer manufactures AMS's products but is currently facing lawsuits for injuries caused by all of AMS’s products.

4. Boston Scientific Corporation

Boston Scientific Corporation's first recalled product was the ProtoGen in 1999 as it caused serious injuries to patients. Despite these issues, the corporation has manufactured other transvaginal mesh products such as advantage sling system, Obtryx curved sling, Prefyx Mid U Mesh Sling System, and Prefyx PPS System. 

The Dangers of TVM

Despite its usefulness in the pelvic health of women in America, transvaginal mesh has brought untold pain among its users. The major problem of TVM arises from marketing by manufacturers and distributors. The misleading notion that the transvaginal kits are usable by general Ob/Gyns and urologists exposes their patients to the risk of complications arising from surgery.

According to Yale Medicine, transvaginal surgery is complicated and requires expertise, which general ob-gyns and urologists lack. Allowing such practitioners to conduct surgeries increases the risks of complications.

Some of the complications of transvaginal mesh include:

• Erosion: mesh erosion is the most common and the most damaging side effect of using transvaginal mesh. TVM erodes the pelvic region of a woman by causing tearing and wearing. Mesh erosion is hard to diagnose, but in some patients, they can feel the mesh or their partners can feel it during sex. Mesh erosion is a major cause of painful sex and painful urination in patients who have received TVM. Correcting such erosion is an expensive process that may require hospitalization, blood transfusions, IV therapy, and drainage of abscesses and hematomas.
• Mesh exposure: when the mesh penetrates the wall of the vagina, it can perforate the lining of the vagina. Such perforation can result in fistula, an equally serious health condition plaguing women worldwide. Mesh exposure results in painful sex for the woman and may irritate the penis of the sexual partner. In addition, such shrinkage will result in chronic pain that may last for the rest of the woman’s life.
• Infection
• Chronic pelvic pain
• Vaginal scarring and disfigurement
• Vaginal shrinkage
• Emotional trauma
• Nerve and muscle damage
• Recurrent pelvic organ prolapse
• Vaginal bleeding
• Mesh shrinkage and movement: once inserted into the vagina, mesh naturally shrinks and embeds into the surrounding tissues. When shrinking happens, women report pain and pulling in their tissues. Such movements can cause difficulties when during movement, sitting, and sex and may cause long-term pain.
• Incontinence: In some cases, insertion of transvaginal mesh may fail to correct incontinence, or some of its complications such as erosion can result in incontinence.
• Painful sex

In addition to these complications, correcting the damage from transvaginal mesh can be expensive and risky. Most of the complications begin to show long after the insertion of the mesh. At such a time, the mesh has already fixed itself firmly on the vaginal walls. Surgical removal then becomes a lengthy and risky process that increases the risk of nerve and tissue damage.

Biocompatibility and Its Effect on the Suitability of TVM

Biocompatibility refers to the interaction of transvaginal mesh with the human body after insertion. After the introduction of new and foreign tissue into the body, it may produce an adverse reaction. When inserted into the body, the transvaginal mesh produces an inflammatory reaction, which is part of its construction design. The inflammatory reaction allows the mesh to set itself into the internal walls. Once the tissue has set, scar tissue forms around the mesh and forms a supportive layer for the pelvic floor.

Scientists use biocompatibility tests to determine the toxicology of medical devices to human cells. Usually, biocompatibility tests on animals prevent human beings from suffering any biological harm from the device.

The biggest problem with the current transvaginal mesh products is their poor biocompatibility. Those made from biodegradable materials blend in with the tissues of the body and offer support to the pelvic floor. However, the synthetic and more permanent mesh are less likely to disintegrate or completely blend with the surrounding tissues. This creates pain and discomfort to its users.

Another issue affecting the biocompatibility is the elasticity of the transvaginal mesh. The vagina is a tissue that expands and contracts regularly; therefore, tissue inserted into the vagina should adapt to the natural functioning of the tissue for seamless functioning. However, the current materials used in the transvaginal mesh are not as elastic as the vagina.

In case inflammation takes longer to subside than expected, then it affects the elasticity of the mesh by making it stiffer. When stiff, the mesh cannot blend in with the surrounding pulling the tissues and causing tearing, perforation, and vaginal erosion.

TVM Lawsuits

The FDA issued the first warning against the use of transvaginal mesh for treating incontinence and pelvic organ prolapse in 2011. In 2016, the FDA classified transvaginal mesh as a Class III device, meaning it is high-risk and could cause serious complications and death. By 2019, the FDA had banned the sale and distribution of transvaginal mesh.

Since then, women who have experienced side effects from TVM implants have sought legal compensation for the damages. The damages resulting from the negligence by manufacturers and the fraudulent marketing of their products, while withholding information about their side effects.

Racketeer Influenced and Corrupt Organizations Act brought a lawsuit against Boston Scientific Corporation for using illegal and counterfeit plastic in the manufacture of transvaginal mesh. The plastic, Marlex polypropylene is an unstable plastic that oxidizes. Boston Scientific apparently ignored all warnings against using the plastic. Even after finding inconsistencies in the illegally acquired plastic, Boston Scientific chose profits over the health of women. Boston did not conduct any tests to determine whether their products were safe or not, choosing instead to market them without warning about their safety risks.

The FDA approved the first transvaginal mesh in 1999, and the company recalled its first product three years later after more than 50% of the women using the device reported serious complications. The recall would be to start the downward spiral for the corporation and mark a decade of legal settlements. In the period between 2014 and 2016, Boston Scientific spent more than $2.9 billion in settling claims and cases related to transvaginal mesh. Within that period, Boston scientific settled about 50% of the approximately 40,000 lawsuits.

Similar to Boston Scientific, Bard also used the same Marlex plastic to manufacture the same product and tried covering up its actions. Bard also knew of the risks of using the plastics but went ahead to manufacture the implants for human use.

Johnson and Johnson is another TVM manufacturer facing lawsuits for transvaginal mesh injuries. The company has paid more than $5.7 million in a lawsuit in response to a California court order. Part of the lawsuits involved accusations against J&J for designed a defective transvaginal mesh and failing to warn the public about the risks associated with using the mesh. J&J failed to obtain the informed consent of both surgeons and patients using their products. A report on the Guardian indicates that, in similar lawsuits in Australia, J&J attempted to prevent French authorities from reporting on the dangers of transvaginal mesh devices before their testing.

America Medical Systems chose to settle claims instead of facing the defendants in court. In 2013, the company paid $54.5 million to settle claims. In 2014, the company paid $830 million to settle about 20,000 claims and has currently spent more than $2.6 billion to settle more than 40,000 claims for transvaginal mesh complications.

How Mass Torts Work

When a product or device causes negative side effects to a large group of people, they can collectively sue the tortfeasor in one lawsuit. A mass tort for defective devices starts with an FDA withdrawal of a product or a device, or a lawyer notices missing details from the product description and investigates it.

In some cases, a mass lawsuit may begin with one victim who sues for compensation from a manufacturer for causing damage to the victim after the use of the product. In the investigation process, a lawyer may find similar victims with similar damages from the product.

When multiple victims are suing the same manufacturer, then the lawyers can request the court to allow a mass tort action. Before the court approves the mass tort, the lawyers have to prove:

• A large number of plaintiffs is involved
• The geographical location of the plaintiffs
• The nature of injuries on the plaintiff and whether they are similar
• The claims are associated with a common product

If the court approves the application, the lawyers may publish a public notice to reach as many people as possible. Other victims may join the mass tort if they have experienced similar or additional side effects from using the product.

If you want to join a mass tort lawsuit, first contact an experienced personal injury attorney who will evaluate your case to determine whether you are eligible for a claim under the mass tort. Once eligible, the attorney may refer you to a lawyer who is involved in the mass tort. The lawyer will provide you with information about the available options and your legal rights.

Join a TVM Mass Tort near Me

The moment you receive a transvaginal mesh, you believe your life has turned around for the better. However, when you start experiencing negative side effects such as chronic pain, pain during sex for both you and your partner, or erosion of your internal tissues, then you may feel disappointed with the treatment. Transvaginal mesh requires surgery during insertion, which could cost you. Dealing with the side effects can require you to have additional surgeries or other medication to control these symptoms.

Consumer Alert Now collaborates with doctors and legal professionals to provide information about defective medical devices such as transvaginal mesh. We inform you about the complications, side effects, and related lawsuits to enable you to make an informed decision about your health. If you are a victim of a defective device, call us today at 800-511-0747 for more information on joining a mass tort.