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Indiana Pharmaceutical Litigation Attorneys

Ethicon Physiomesh® Flexible Composite Hernia Mesh

Our firm is now investigating claims of individuals who received Ethicon Physiomesh® Flexible Composite hernia mesh.

The product was voluntarily recalled in May 2016, after Ethicon, a Johnson & Johnson subsidiary, approached a pair of observational hernia repair registries seeking an analysis of the product's success rate. The registries determined that the Ethicon device failed at higher rates compared to that of similar hernia mesh repairs. Even though the studies were not published, key details were made public in removal notices released by Johnson & Johnson. Patients with the Ethicon device suffered above average hernia recurrence and reoperation rates following laparoscopic procedures, according to the notice.

If you or a loved one have had hernia repair surgery using Ethicon Physiomesh® Flexible Composite hernia mesh, and have since suffered from hernia recurrence requiring additional surgeries, then please contact our office to evaluate your potential claim.

Bard Composix® Kugel Mesh Hernia Patch

What is Kugel Mesh?
The Bard Composix® Kugel Mesh Hernia Patch is used by physicians to repair ventral hernias. The Patch is manufactured by C.R. Bard, Inc., and their subsidiary, Davol, Inc. The Patch is made from two pieces of mesh that surround a plastic ring. A surgeon places the mesh patch in a small incision, at the site of the hernia. The ring then springs back into its original shape, flattening the patch. The mesh-like material allows the hernia patient's own tissue to grow and assist in healing the hernia.

What are the medical and legal issues with Kugel Mesh?
The Bard Composix® Kugel Mesh Hernia Repair Patch Recall has been upgraded by The FDA to "Class I" because the use of the Bard Composix® Kugel Mesh Large Patch has a reasonable probability to cause serious injury, including death.

The FDA issued an immediate recall of Bard Composix® Kugel Mesh Hernia Repair Patches on December 22, 2005 and updated the list again on January 10, 2007.

The "memory recoil ring" that opens the Bard Composix® Kugel Mesh Patch can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections between the intestines and other organs).

The FDA has advised patients to seek medical attention immediately if abdominal pain, fever, tenderness at the implant site or other symptoms occur. The FDA has ordered surgeons and hospitals to immediately stop using the recalled products and return the unused patches to the company.

Contact us to Discuss Your Claim

We are now evaluating claims for patients with Recalled Bard Composix® Kugel Hernia Mesh Patches where the memory recoil ring has broken. If you or a loved one has had hernia surgery and received a Bard Composix® Kugel Patch please contact our Indiana based class action lawyers to assess any potential claim and possible lawsuit.

Testosterone

Riley Williams & Piatt, LLC is investigating potential legal claims for men who have had a heart attack, stroke or died while using prescription testosterone products.

On Jan. 31, 2014, the FDA issued an alert announcing that it was investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products. This was due to the release of two separate medical studies that suggest an increased risk of cardiovascular events among men taking prescribed testosterone therapy.

What is testosterone replacement therapy?
Testosterone replacement therapy is prescribed for men for the decline in testosterone as they get older and is approved specifically for the treatment of abnormally low testosterone levels (called hypogonadism), commonly referred to as "low T." Testosterone helps a man to build muscle, reduce body fat and improve sex drive. More than 5 million prescriptions for testosterone were written in the United States in 2011 alone. Testosterone therapy is most often given as a gel, patch or injection.

Studies about Low T Therapy
The UCLA and National Institutes of Health and Consolidated Research authored a joint study in 2014 that found prescription testosterone raised the risk of heart attacks in older men and in middle-aged men with a history of heart disease. The study tracked about 56,000 older and middle-aged men between 2008 and 2010 who lived all over the United States and who were prescribed testosterone.

In January 2014, the PLoS ONE study, found that the risk of non-fatal myocardial infarction (MI) increased two-fold in men 65 years of age or older within 90 days of starting testosterone therapy. Younger men with no history of heart disease did not have an increased risk of myocardial infarction. However, younger men who did have a history of heart disease had a two-to three-fold risk of experiencing a myocardial infarction in the 90 days from beginning testosterone therapy.

Additionally, the Journal of the American Medical Association (JAMA), in a November 2013 study, reported a link between testosterone supplements and an increased risk of death, heart attack and stroke. The JAMA study examined the health records of more than 8,700 men with low testosterone who had coronary angiography—a test to determine plaque buildup in blood vessels—in the Veterans Administration system between 2005 and 2011. This study found that those who used testosterone supplements were about 30 percent more likely to have a heart attack, stroke, or die after three years of use. In the study of the men who had testosterone therapy, nearly 26% of them suffered a heart attack, stroke or died for a reason included in the study within the next three years, compared with 20% of those not taking testosterone. The study found that men who began the study with clear coronary arteries were just as likely to have a heart attack, stroke or die as men who entered it with established coronary artery disease. This difference could be seen even after the researchers took into confounding facts such as age, blood pressure, the presence of heart disease and other factors.

A study published online in the New England Journal of Medicine in June 2010 also found that testosterone treatment in men aged 65 years and older, who suffered from limits to their mobility, there was an associated increased risk for cardiovascular events, including heart attacks and hypertension. Because of these events, the treatment phase of the trial, was abruptly stopped.

Low T Products – Brand Manufacturers
  • Androgel – AbbVie Pharmaceuticals
  • Androderm – Actavis, Inc.
  • Axiron – Ely Lilly & Company
  • Bio-T-Gel – Biosante/Teva Pharmaceutical Industries
  • Delatestryl – Sandoz Canada Inc.
  • Depo Testosterone – Pfizer Inc.
  • Foresta – Endo Pharmaceuticals
  • Striant – Actient Pharmaceuticals
  • Testim – Auxilium Pharmaceuticals
  • Testopel – Auxilium Pharmaceuticals
Low T Products – Generic Manufacturers
  • Testosterone Cypionate – Paddock Laboratories, Inc. (Perrigo Co.)
  • Testosterone Cypionate – Watson Pharmaceuticals (now Actavis)

Do you have a potential claim?

If you or a loved one has suffered a heart attack or stroke, or has died, while taking prescription testosterone replacement products, please contact one of our Pharmaceutical Drug Litigation Attorneys at Riley Williams & Piatt, LLC to discuss your potential claim.

Bard IVC Filter

Inferior Vena Cava ("IVC") filters are similar to tiny birdcage-like devices which inserted into the inferior vena cava to capture blood clots and prevent them from making it to the lungs. IVC filters are often put in patients who are at risk for pulmonary embolism (PE, or a blood clot in the lungs) when anticoagulant therapy for the patient is ineffective or contraindicated. If patients require long-term protection from PE, then surgeons may implant permanent IVC filters. If people require short-term protection, doctors may implant a retrievable IVC filter that allows for device removal once PE risk subsides.

FDA Warning: Filters for Short-Term Use Only
On May 6, 2014, the FDA updated its safety communication: “Removing Retrievable Inferior Vena Cava Filters.” In August 2010, the FDA had issued an initial warning against leaving inferior vena cava filters implanted in patients for extended periods because of their potential to cause adverse health complications. The FDA warned that IVC filters are meant for short-term use only. Implanting doctors are instructed to remove the devices once the risk of pulmonary embolism subsides. The FDA was concerned about doctors not retrieving IVC filters intended only for short-term placement, hence exposing patients to fractured implants.

FDA reports Adverse Events
Since 2005, the FDA said it has received “921 device adverse event reports involving IVC filters, 328 for device migration; 146 for embolizations (detachment of device components); 70 for perforation of the IVC; 56 for filter fracture.” The FDA stated:
“The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.”

IVC Filter Complications
  • Fracture of the IVC Filter
  • Perforation, Puncture or Serious Damage to the Heart
  • Damage to the Lungs or Vena Cava
  • Internal Bleeding
  • Cardiac or Pericardial Tamponade
  • Ventricle Tachycardia
  • Lower Limb DVT
  • Hematoma or Nerve Injury at the Puncture Site
  • Constant and Severe Pain in the Heart, Chest, elsewhere
  • Pulmonary Embolism
  • Infection
  • Death
  • Bard IVC Filters
  • Celect
  • Cook IVC Filter
  • Eclipse
  • G2
  • G2 X
  • G2 Express
  • Gunther Tulip
  • Meridian
  • Recovery

File an IVC Filter Lawsuit

Contact Riley Williams & Piatt, LLC now for a free legal consultation regarding an IVC Filter lawsuit or other IVC filter manufacturer lawsuit if you or a loved one has suffered serious complications after being implanted with an IVC filter.