Articles Posted in Hernia Mesh Failure

Hernia mesh is a flexible mesh product used to repair abdominal hernias. The mesh device is implanted over the weakened area, creating a barrier that prevents internal organs from pushing through. All types of hernia mesh are associated with medical complications, but Ethicon Physiomesh has a particularly bad record. Failure rates are high, resulting in the need for revision surgeries at best, or life-threatening health complications at worst.

When new medical devices that are similar to existing medical devices enter the market, they often receive FDA approval through a fast-track approval process called 510(k). Basically, this means that the device’s manufacturer must demonstrate only that the new device is a substantial equivalent to a previously approved device. As such, rigorous safety testing and research goes by the wayside in favor of getting the product to market as fast as possible. A Boston defective medical device lawyer can help you determine how to proceed if you’ve been injured by hernia mesh.

Ethicon Physiomesh is manufactured by corporate giant Johnson & Johnson. J&J was named the largest healthcare company on the planet at the 2016 World Economic Forum. With such a large share of the global healthcare market, J&J should be more diligent about safety testing its products. And hernia mesh is far its only dangerous product. With J&J’s baby powder being linked to ovarian cancer in women, Risperdal being linked to breast development in adolescent men, and Xarelto causing excessive bleeding in patients, J&J is at the center of lawsuits totaling in the hundreds-of-millions.

Medical Complications Linked to Physiomesh

All types of hernia mesh carry the risk of complications, but the material used to make Physiomesh is especially dangerous. If you have a hernia mesh implant, talk to your doctor about the risk of the following:

• Mesh erosion
• Organ perforation
• Infection, including gangrene and sepsis
• Bowel adhesions
• Wounds that won’t heal
• Allergic reactions
• Severe pain
• The need for revision surgery
• Death

Ethicon Physiomesh is made with a lightweight plastic called polypropylene. Multiple clinical studies have show that polypropylene decays when implanted in a human body. In addition to the breakdown of the mesh itself, the device can migrate, puncturing or perforating surrounding tissue and organs. This migration can result in internal bleeding and life-threatening infections. A MA injury attorney can help you recover damages if you’ve been injured by a hernia mesh device.

Recent Updates

• On October 3, 2017 the Supreme Court rejected J&J’s request to overturn a $3.27 million verdict.
• In September 2017, J&J was ordered to pay $57.1 million in a mesh injury case in Pennsylvania.
• On Sepember 26, 2017, Alex Neil, a former Health Secretary of Scotland, called the injuries caused by pelvic mesh a “worldwide catastrophe,” and requested an International Summit to address this problem.
• On May 1, 2017 a New Jersey woman received a $20 million verdict against J&J for injuries caused by a vaginal mesh device (similar product).

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The TV commercials and radio advertisements are everywhere – if you have recently undergone hernia repair surgery, you may be entitled to recover for any complications suffered as a result. Not only is it important to understand that this is an option, it is also important to understand why, and what to look for after your surgery. Becoming part of a lawsuit for a defective hernia mesh product can be appealing for several reasons: not only because it provides a remedy for the pain and suffering you have gone through, but also as more studies are conducted to find which mesh products are causing problems, more corporations are being added to lawsuits, including giant corporations like Johnson & Johnson. With the addition of more corporations, comes the increased likelihood of large payouts. After reading this, if you feel that you have been affected by a defective mesh product following your hernia repair surgery, contact your medical provider to see if it was produced by a company like Johnson & Johnson (through their Ethicon unit) that is known to manufacture faulty mesh products.

Depending on the type of surgery, and the amount of damage, the way mesh is used may vary from patient to patient. But in general, the mesh is sutured on the abdominal wall, either on top of or behind the wound site. Once secured in place, it allows for new tissue to grow while simultaneously protecting the growth site. However, recent studies have shown that certain mesh products, especially those made out of polypropylene (like Ethicon’s Physiomesh) are not conducive to working with human tissue. In fact, recent studies have shown that “the scientific evidence shows that the polypropylene material from which the product is made is biologically incompatible with human tissue and promotes a negative immune response in a large subset of the population implanted with the products.”

You may be asking why surgeons continue to use this mesh in their hernia repair procedures. Recent studies, although many of them are apparently funded by mesh manufacturers, have stated that using mesh, “the repair can be done without putting tension on the tissue, which in turn reduces the likelihood of a hernia recurrence … [some studies] suggest that half of all hernia repairs without mesh fail, while only 20 percent of mesh repairs fail.” Despite the potential for skewed studies, the general consensus among medical providers still seems to be that using mesh is the trusted, recommended, and most common way to conduct hernia repair surgeries.

More than 100,000 hernia mesh devices are implanted in patients annually in the United States. Despite growing evidence that these medical products come with a high risk of complications, several of the most dangerous types of hernia mesh products remain on the market today. A Boston defective medical products attorney can help you determine how to proceed if you’ve been injured by a hernia mesh implant.

The FDA is aware of the serious risk associated with hernia mesh implants, but incorrectly claims that most of the dangerous mesh products have been recalled. Here is an excerpt from a 2016 statement put out by the FDA: “Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.” However, only one month after the release of this statement, Ethicon, a subsidiary of Johnson & Johnson, recalled its Physiomesh hernia mesh product after mounting reports of serious injuries.

Why are Hernia Mesh Products So Dangerous?

Earlier this month, a federal judge ordered Caldera Medical to pay a total of $12.3 million to settle over 2,700 injury claims related to the company’s transvaginal mesh products. Tens of thousands of women have suffered injuries as a result of transvaginal mesh products from multiple manufacturers. Many of the women allege that manufacturers provided “false and misleading information” about the effectiveness and safety of the products. Complications range from severe pain to the need for multiple revision surgeries. If you have been harmed by a mesh implant, read on for more information about legal options that may be available to you.

Why Should Transvaginal Mesh Manufacturers Be Held Accountable?

Lawsuits against mesh manufacturers include several allegations, including that they:

• Intentionally mislead physicians, patients, and the FDA as to the safety and effectiveness of their products.
• Failed to perform adequate testing on the use of mesh products for treating disorders of the female pelvic floor.
• Failed to determine safe methods of removal for when complications arise.
• Failed to properly and adequately warn patients and physicians of associated risks.

Complications Associated with Transvaginal Mesh

Within weeks of surgery, mesh can begin eroding through vaginal walls. The result can be extremely painful, and injuries may be permanent. Possible complications include:

• Severe pain
• Erosion of the mesh
• Pain during sexual intercourse
• Abdominal pain
• Urinary incontinence
• The need for revision surgeries

A Boston defective medical products attorney can help you determine how to proceed if you’ve been injured by transvaginal mesh. Due to the nature of the complications, injuries can be emotional as well as physical. A woman from Illinois is suing the manufacturer of her mesh product for nearly $10 million as a result of the complications she experienced. Jill L. Dewey had the medical product implanted in 2005 following her organ prolapse.

In addition to the above cases, thousands of federal lawsuits have been consolidated in multi district litigation (MDL), and thousands more are currently pending at the state level. The manufacturers facing the lion’s share of the lawsuits are Ethicon and American Medical Systems, but Boston Scientific, Coloplast, C.R. Bard, Neomedic, and Cook Medical are also facing their fair share of injury claims.

If you have received a transvaginal mesh implant and are concerned about the associated risks, speak to your healthcare provider. If you have been injured due to a mesh device, or a similar medical product, a MA injury lawyer can help you obtain the compensation you deserve for your injuries.

More Defective Medical Products

In addition to transvaginal mesh products, several other medical devices have caused serious harm to patients in recent years. The devices below have been at the center of tens of thousands of injury claims.

• Metal hip replacements
• Drug-coated stents
• Guidant defibrillators
• IVC blood clot filters
• DaVinci surgical robots

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Surgeries for hernia repairs are extremely common in the United States. In fact, about 500,000 surgical repairs are performed annually. Unfortunately, the hernia mesh devices used in many repairs are linked to multiple serious injuries, including organ perforation and bowel obstruction. If you have been harmed due to a mesh implant, the information below will help you determine whether to seek the counsel of a Boston hernia mesh injury lawyer.

Hernia mesh works by covering or “plugging” the areas of weakened muscle in the abdomen. There are several different types of hernia mesh, including those made from synthetic materials and those made from biologic materials. Synthetic mesh is typically made of polypropylene, composite mesh, or polyester fibers whereas biologic mesh is derived from animal or even human tissue.

Complications Related to Hernia Mesh Products

In the past decade, hernia mesh products have faced increased scrutiny about the harm that they may cause to patients who are fitted with them. Hernia mesh products are intended to support weakened muscle to help a hernia heal, and prevent it from re-erupting. Studies have shown that hernia mesh products do indeed lessen the likelihood of reoccurrence of hernias.

However, studies have also started to reveal that hernia mesh products can cause serious, and in some cases life-threatening, complications to patients that are fitted with them. The most serious of which include nerve damage, fistulas (an abnormal connecting together of organs that are meant to remain separated), bowel blockages and negative autoimmune reactions when the body rejects the mesh.

Ethicon is a subsidiary company underneath the umbrella of pharmaceutical conglomerate Johnson & Johnson. The company has manufactured surgical sutures and wound closure devices since 1887. They are responsible for about 80 percent of the total United States market share of surgical sutures and are present in 52 countries worldwide.

Hernia mesh is a surgical product used to repair hernias. The screen-like material goes under or over the weakness, or it can act as a plug. Unfortunately, surgical mesh has been linked to serious, life-threatening complications. The most common risks associated with hernia mesh implantation are perforation, infection, and adhesion. Many of these devices contain polypropylene, a type of plastic commonly used in medical products. However, according to the Polypropylene Material Data Safety Sheet, permanent implantation is listed under “prohibited uses.” As hernia mesh is intended to be a permanent product, this statement has raised many questions.

FDA Warning

Last year, the Food and Drug Administration (FDA) released on article on the dangers of hernia mesh implants.

Hernia mesh is a medical device used to repair hernias by either covering the hernia or acting as a plug. Hundreds of thousands of hernia surgeries are performed annually; some use hernia mesh and some do not. In most of these surgeries, patients recover quickly and little to no complications arise. However, the Food and Drug Administration (FDA) has received numerous reports of complications involving hernia mesh.

The FDA has reported various complications associated with hernia mesh products, including intestinal adhesions (occurs when parts of the intestine adhere to the mesh), reactions to the mesh, infection, severe and chronic pain, injuries to organs and nerves, and the need for revision surgery. Although most of these complications have been linked to hernia mesh products that have already been taken off the market, some products are still being used today. If you have been injured by hernia mesh or any other type of medical device, contact a Boston defective medical products lawyer today.

What is a Hernia?

A hernia occurs when part of an organ, typically the intestine, pushes through a weakened spot in the groin or abdomen. The most obvious hernia symptom is a visible bulge in the abdomen or groin area. It is often painful. Additional symptoms include bloating and constipation, back pain, and bloody bowel movements. Hernias are often caused by activities that require overexertion, such as lifting, carrying, or pushing heavy objects. Certain factors can increase your risk of developing a hernia, including obesity, smoking, and age. If you think you may be suffering from a hernia, contact your health care provider immediately.

Types of Hernia Mesh Linked to Injuries

There are multiple types of hernia mesh associated with complications, but most lawsuits involve the following four types:

Ethicon Physiomesh: Recalled in 2016, Ethicon Physiomesh was linked to a high rate of failure. The company has demanded the return of all unused inventory, and has no plans of bringing the product back to market.  Atrium C-Qur Mesh: This polypropylene mesh product has been linked to multiple complications. In 2012, the FDA issued a warning to the manufacturer, claiming it had failed to respond to and investigate complaints. If you have been injured by an Atrium C-Qur Mesh product, contact a Boston injury lawyer today.

Kugel Hernia Mesh Patches: Multiple Kugel hernia products have been recalled following reports of injuries. A coil ring within the mesh may break, causing internal injuries and severe pain.

AlloDerm Regenerative Tissue Matrix: A hernia patch manufactured from human cadaver tissue, the AlloDerm Regenerative Tissue Matrix has been linked to multiple complications. Apparently, the patch requires pre-stretching, a crucial step which was not effectively communicated to health care providers. When proper pre-stretching does not occur, the patch can expand after implantation, causing severe pain and injuries. Continue reading