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Articles Posted in Hernia Mesh Failure

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

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