Vaginal Mesh Implants – Complications

The majority of women are given vaginal mesh implants to treat prolapse or incontinence.

A growing number of women have had serious complications as a result of their vaginal mesh implants, and if you have been affected by vaginal mesh implants complications in Ireland, you can discuss your situation in strict confidence with a member of our medical negligence and defective products team.

Currently in the United Kingdom, more than 800 women are bringing an Action against the NHS and the manufacturers of their vaginal mesh implants, after suffering severe complications.

In France, some families of children born with birth defects to women who took Sanofi while pregnant are suing the company, claiming that it failed to warn them adequately of the risks.

These complications include:

• Bleeding
• Pain
• Nerve damage
• Vaginal scarring
• Infection
• Vaginal shrinkage (via scar tissue)
• Painful sexual intercourse
• Neuro-muscular problems
• Mesh erosion
• Organ perforation

In early 2015, new guidance concerning the use of sodium valproate was released by the Medicines and Healthcare Products Regulatory Agency (MHRA). It urged medical professionals to give women better information about the risks of taking the drug.

This was as the result of a European review of sodium valproate in 2014. The review found that up to 40 per cent of children born to women who took valproate during pregnancy experienced adverse effects. These children demonstrated problems including neurodevelopmental disorders as they grew.

The European Medicines Agency released information in November 2014 titled CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls wherein it clearly stated that taking valproate while pregnant could be detrimental to the foetus.

“In countries where valproate medicines are also authorised for the prevention of migraine, valproate must not be used for this purpose in pregnant women, and doctors should exclude pregnancy before starting preventive treatment for migraine. Doctors must not prescribe valproate for migraine prevention for women who are not on effective contraception. These recommendations follow a review of recent studies showing developmental problems in up to 30 to 40% of pre-school children exposed to valproate in the womb, including delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability.1,2,3,4,5 Previous data have shown that children exposed to valproate in the womb are also at increased risk of autistic spectrum disorder (around 3 times higher than in the general population) and childhood autism (5 times higher than in the general population). There are also limited data suggesting that children exposed to valproate in the womb may be more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD).”

European Medicines Agency

Claims made following the Transvaginal mesh procedure

Thousands of claims have been lodged against Ethicon Inc. one of the manufacturers of this device and it’s parent company Johnson & Johnson. These claims have alleged that the device was defective and negligently designed in that the mesh was made of polypropylene which is not safe for use in the human body.

The U.S. Food and Drug Administration (FDA) in the late 1990s and early 2000s approved transvaginal mesh implants as a treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Early on, these products were embraced by doctors as a simpler, easier way to create a long-term solution for women suffering from these embarrassing and often debilitating conditions. With nearly 500,000 of these surgeries performed each year, many medical device companies saw a potentially lucrative market to enter. Since the first vaginal mesh product was approved by the FDA, dozens of vaginal mesh products have entered the market.

Paving the way for so many companies to produce multiple brands of mesh was an FDA decision to make transvaginal mesh a Class II product. This classification put a lighter burden on manufacturers to gain approval for their new products. Under Class II guidelines, and the FDA 510k program, manufacturers are only required to show that the device they are producing is substantially similar to a product that has already been approved and is on the market. This made it very easy for manufacturers to quickly and easily bring new vaginal mesh products to market.

Although there are a large number of companies manufacturing vaginal mesh, there are five companies considered dominant in the market: Johnson & Johnson, Bard Medical, American Medical Solutions, Boston Scientific and Coloplast. These companies produce multiple brands through multiple subsidiaries, making billions of dollars in profit every year.

Johnson & Johnson/Ethicon Transvaginal Mesh Products

Of all the mesh manufacturers, J&J’s Ethicon has been the slowest to offer settlements. The company also faces the highest number of federal lawsuits in the US. In January 2015, the company settled four lawsuits for an undisclosed amount.

A federal jury in West Virginia awarded $3.27 million to Jo Husky in September 2014. Huskey claimed her Ethicon Gynecare TVT mesh caused permanent injuries and the company failed to warn her.

In 2013, a New Jersey jury returned an $11 million verdict against Ethicon for injuries caused by its Gynecare Prolift. Another woman also won $1.2 million in Texas state court against J&J.

Drugmaker Johnson & Johnson was eager to jump into the emerging mesh market and created a new mesh product line through its subsidiary, Ethicon Inc. Ethicon was charged with developing “easy-to-use” surgical mesh kits. These kits provided doctors with pre-cut mesh and the tools needed for the implant procedure.

Surgeons embraced the convenient new kits. They quickly became the preferred treatment for prolapse and incontinence. Ethicon’s Gynecare brands were believed to be superior to traditional surgery, but doctors had many more complications than they expected. The surgical mesh was difficult to implant, and complaints of severe post-surgery complications were common.

In June 2012, amid mounting legal pressure and growing concern from the FDA, Ethicon announced that it would no longer manufacture and distribute vaginal mesh products. However, both Ethicon and J&J have refused to call the decision a recall.

Because of the injuries caused by these products, over 25,400 lawsuits have been filed against Ethicon and J&J in the United States alone.

Gynecare Prolift Kit

J&J started selling the Gynecare Prolift Kit for prolapse treatment in 2005 without marketing approval from the FDA. The FDA scolded J&J for breaking the rules, but approved the Prolift anyway in 2008.

Gynecare TVT Secur

The Gynecare TVT Secure was the first mini bladder sling used in the United States. Instead of using needles, the U-shaped TVT Secur has built-in blades for attaching the mesh. However, the TVT Secur is more likely to loosen after surgery.

Gynecare Prosima Pelvic Floor Repair System

J&J tried to perfect the mini bladder sling with the Gynecare Prosima Kit. It uses slits cut with scissors to implant the mesh, instead of needles. A tiny balloon is then placed on top of the anchored mesh and inflated to support organs after surgery. The balloon is removed 24 hours after the operation. Because of the way it is attached, this mesh is useful only if incontinence is caused by organs dropping to the back of the vagina; it is likely to fail if organs prolapse toward the front.

Gynecare Prolift + M Kit

In another effort to avoid patient complaints of vaginal scarring and perforationJ&J created the Gynecare Prolift +M to treat prolapse. It was the first surgical mesh in the United States to use plastic fibers that could be partially absorbed by the body. This mesh isn’t as dense as the Prolift, and it has larger holes that are supposed to help patients heal after surgery. The mesh also resists folding and wrinkling. Despite J&J’s efforts, the Prolift + M eroded and shrank, just like many of its other mesh brands.

Bard Medical Transvaginal Mesh Products

Like Johnson & Johnson, Bard Medical’s brands were approved under the 510(k) process. Bard even outsourced the clinical testing for its Alyte Y-Mesh device, relying on data from a 2010 European survey of 17 surgeons to get the brand approved by the FDA. Bard makes transvaginal mesh kits for both prolapse and incontinence.

Almost 11,000 patients who received Bard transvaginal mesh have already filed lawsuits against the company for injuries related to the products. These women suffered from erosion, organ perforation, nerve damage, migrated mesh and infection caused by Bard’s brands.

Bard Transvaginal Mesh Products

Endo Pharmaceuticals/ American Medical Systems’ Transvaginal Mesh Products

American Medical Systems made mesh for both stress urinary incontinence and pelvic organ prolapse throughout the 2000s. In 2011, the company was purchased by Endo Pharmaceuticals. Some patients are suing both Endo and American Medical Systems to recover medical costs from injuries sustained from their transvaginal mesh products. Removal and revision surgeries for American Medical Systems transvaginal mesh brands happen frequently. Endo argued it could be sued for the actions of its subsidiary. However, by 2015, it had already paid close to $900 million to settle AMS lawsuits.

Boston Scientific Transvaginal Mesh Products

Boston Scientific is facing over 16,400 lawsuits over its mesh and incontinence products. Like the other manufacturers, Boston Scientific’s brands injured many patients when the faulty mesh eroded and punctured organs. The company has stated it still believes transvaginal mesh is an important treatment for incontinence and pelvic organ prolapse. Boston Scientific’s revenue was $7.6 billion in 2011, and transvaginal mesh sales made up less than 5 percent of the company’s revenue.

Coloplast Transvaginal Mesh Products

Coloplast markets mesh products for repair of prolapse and incontinence. As of June 2015, the company is still facing almost 2,000 lawsuits, which have been consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of West Virginia. The patients say Coloplast’s mesh products caused serious injury. In 2014, the Danish company offered $16 million to settle about 400 suits.

The FDA ordered dozens of manufacturers to conduct studies on their mesh products, including Johnson & Johnson/Ethicon, Bard Medical, Endo Pharmaceuticals/ American Medical Systems, Boston Scientific and Coloplast. While each company makes its own version of transvaginal mesh many of the products are similar in both their design and the material used to construct the mesh. Most transvaginal mesh brands are prone to erosion and organ perforation. Because the complaints the FDA received on mesh complications are not tied to any specific transvaginal mesh manufacturer, all companies that produce transvaginal mesh brands are potentially liable for compensating patients for injuries caused by their products.

Other Transvaginal Mesh Manufacturers and Products

Source: drugwatch.com