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Hernia mesh lawsuit complications, failure & recall

Hernia mesh complications: Who’s affected?

Hernia mesh defects are causing extra surgeries and issues for patients

investigation text

  • Have you suffered from hernia mesh complications?
  • You may be able to take legal action for the pain and suffering you have experienced caused by faulty hernia mesh.
  • Fill out the form on this page to see if you qualify for a free hernia mesh lawsuit claim review.

Hernia mesh lawsuits allege that the mesh devices are defective and that hernia mesh makers failed to warn patients about potential adverse side effects. Some of the medical device makers that have faced lawsuits include Atrium, Bard Davol, and Ethicon.

Hernia mesh injuries Alleged lawsuits include:

  • Adhesions (bands of scar tissue)
  • Bowel obstruction
  • infection
  • Mesh failure
  • Meshoma (when mesh has shrunk and can trap nerves/cause chronic pain)
  • migration
  • perforation
  • Seromas (fluid pockets)
  • Others

Such complications may require additional hernia surgery to resolve. If you or someone you love has suffered from these or other hernia mesh injuries, you may be able to file a lawsuit and pursue compensation.

Do You Qualify?

If you or a loved one suffered complications after a hernia mesh device was used to repair a hernia, you may qualify to join a hernia mesh lawsuit.

A hernia mesh lawsuit may help you obtain compensation for the following:

  • Medical expenses
  • Pain and suffering
  • Treatment recovery
  • Balance losses
  • Punitive damages

Fill out the short form on this page to see if you qualify for a free case evaluation.

What causes hernia mesh complications?

hernias occur when there is a weakness or hole in a muscle or connective tissue, allowing organs, intestines, or tissue to squeeze through the openings and become trapped. This usually results in a bulge that may be visible externally. Hernias can be caused by weakened muscles that have either been present since birth, or are linked with factors like age and repeated strains on the abdominal and groin areas, such as through physical exertion, obesity, pregnancy and frequent coughing. In some cases, hernias are repaired by sewing the muscle walls around the hole directly together. In other cases, a hernia mesh is used to repair the hole.

Hernia mesh is a medical device made of plastic or metal mesh that is placed in the hernia. It strengthens the weakened area and prevents internal organs and tissues from protruding through the hernia causing pain or medical complication.

dr Andrew T Bates of Stonybrook Medicine discusses the benefits and risks of using hernia mesh in hernia repair. He explains that the devices grew in popularity after research indicated that there was a lower instance of hernia reappearance in instances in which hernia mesh was used, in comparison to those repairs in which no mesh was used. In the case of some types of hernias, the use of mesh dropped the rate of recurrence from 25 – 50% to under 5%. While hernia mesh does often decrease a patient’s risk of having their hernia reappear, use of the device comes with its own set of complications. The implantation of any medical device into the human body comes with risks. However, some particular risks of hernia mesh have both patients and doctors discussing the efficacy of the devices.

Hernia mesh complications can come in a number of forms. Broadly, they can be caused by:

  • The human body rejecting the medical device as a foreign body
  • The hernia mesh being placed incorrectly or moving from its correct placement
  • Defective materials breaking down or causing harm to the patient’s body
  • The design of the hernia mesh’s shape preventing the device from working correctly
  • Infection or complication during the surgery to implant the mesh

Hernia mesh complications may be caused by defects with hernia repair mesh products, entitling consumers to take legal action.

Generally speaking, hernia mesh products may be defective because they were placed on the market despite manufacturers being aware of the following concerns:

  • Polypropylene is not suitable for implantation in the human body
  • Heavy-weight polypropylene can bunch, curl, migrate, and cause nerve, tissue, and organ damage
  • Minimal animal testing supported the product safety and efficacy
  • No clinical trials in humans prior to putting products on the market
  • Doctors were concerned and warned about increased adverse events

What are the potential problems with hernia mesh?

Although hernia mesh products are widely used to repair hernias, these products may be associated with serious complications. Some of these complications may include:

  • Recurrent hernia: A hernia may happen again despite mesh repairmeaning further surgery for patients.
  • Mesh-related complication: A variety of problems can occur with a mesh product that can cause it to reject.
    • Mesh infection: If any bacteria contaminates the mesh during surgery, it may cause a serious infection.
    • Mesh folding: The mesh product may fold inside the body, forming small balls called meshomas. This can also lead to hernia recurrence.
    • Mesh reaction: If the body reacts with the implanted mesh, this can cause pain and other rejection symptoms.
    • Hernia mesh migration is also a potential issue for patients with these devices, which means that the device has fallen out of place and can lead to infection or organ perforation.
  • Chronic pain: This can be caused by nerve injury, meshomas or mesh reaction, or the recurrence of a hernia.
  • Any of these complications can cause significant pain to patients and may require additional hernia mesh revision surgery to resolve.

Up to 170,000 British patients may be experiencing hernia mesh complications if they underwent hernia repair surgery in 2012 or later, according to a study published in the British Medical Journal (BMJ).

Patients who had had hernia mesh surgeries talked about “being in constant pain, unable to sleep, and finding it difficult to walk or even pick up a sock. Some patients said that they felt suicidal,” the BMJ reports.

Complications caused by hernia mesh can be detrimental to a patient’s quality of life, but relief may be possible. The rejected product can be removed surgically and compensation may be available if consumers take legal action against hernia mesh manufacturers.

What are the types of hernia?

A hernia can occur in a variety of locations in the body, which changes what type of hernia it is. Hernia types include:

  • inguinal: hernia in the inner groin
  • Femoral: hernia in the upper thigh or outer groin
  • Incisional: hernia through an incision or scar on the abdomen
  • Ventral: hernia in the general abdominal area
  • Umbilical: hernia at the belly button
  • Hiatal: hernia inside the abdomen along the diaphragm or upper stomach area

The Physiomesh Flexible Composite Mesh device was approved by the US Food and Drug Administration (FDA) in March 2010, through the federal agency’s 510k fast-track approval program. This program allows medical device makers to pursue approval of a product by showing that it is “substantially equivalent” to a similar product, without the standard requirements such as testing and research.

The Physiomesh hernia patch is described by Ethicon as a “sterile, low profile, flexible composite mesh designed for the repair of hernias and other fascial deficiencies.” It is made with a macroporous polypropylene that is held together by two undyed polygelcaprone-25 films.

After its approval, the Physiomesh quickly became a widely used hernia surgery mesh. However, it also became associated with more hernia mesh problems than expected after Ethicon’s hernia mesh product was used for laparoscopic ventral hernia repair. Complications reported include hernia recurrence, removal surgery, infections, wound problems, and abdominal pain.

This high rate of hernia mesh failure led Ethicon to remove the product from the market. In a May 2016 announcement, the removal of Ethicon’s Physiomesh Flexible Composite mesh was categorized as a “Market Withdrawal” and not a recall on the product itself.

Ethicon allegedly failed to clearly define the factors behind the high hernia mesh failure rate. Ethicon said that the failure rate could be due to several factors: design, the physician’s instructions, and patient selection.

Ethicon hernia mesh repair lawsuits

Several hernia mesh repair lawsuits have been filed over failed Physiomesh hernia mesh products with some of the following allegations:

  • Failure to perform adequate research of the product
  • Failure to warn about the complications linked to the product
  • Providing misleading information about Physiomesh’s safety
  • Defective instructions for surgeons
  • Failing to make a safer mesh product

Compensation from hernia mesh lawsuit settlements

If you undergo hernia surgery and suffer side effectsyour complications may be the result of a defective mesh product made by one of the four main hernia mesh manufacturers: Ethicon, CR Bard, Covidien, and Atrium.

Each of these manufacturers has multiple models of hernia mesh products. The following list includes some of the hernia mesh products from each manufacturer:

  • CR Bard Hernia Mesh Products: Sepramesh, Ventralight ST, Ventralex ST, Ventrio ST, Ventralex, Composix, Kugel, Ventrio, Dulex, Marlex/Sheet Mesh, Perfix, Perfix Lite, 3D Max, 3D Max Lite, and Keyhole Mesh.
  • Covidien Hernia Mesh Products: Paretex (including Composite, Plug-and-Patch, Pro-Grip, etc.), Surgipro, and Symbotex.
  • Atrial Hernia Mesh Products: C-Qur (multiple subtypes include V-Patch, Tacshield, etc.), and Proloop.
  • Ethicon Hernia Mesh Products: Physiomesh, Proceed, and PHS (Prolene Hernia System).

If you have been injured from hernia mesh failure, you may be entitled to file a hernia mesh repair lawsuit and receive damages for:

  • Past and future medical expenses, including revision surgery, infection treatment, perforations, care for chronic pain, and more
  • Pain and suffering caused by the injuries, treatment, and recovery process
  • Lost wages you incurred or will incur from inability to work
  • Punitive damages, if appropriate

You may qualify to seek compensation for your injuries through a hernia mesh repair law suit.

Please fill out the form on this page to see if you qualify for a free case evaluation.

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