Defective Medical Devices

Hernia Mesh

Purpose of the Device

Surgical hernia mesh is a type of medical device intended to provide extra support to repaired tissue previously damaged or weakened by a hernia. While some studies have shown surgeries using mesh lead to fewer hernia recurrences, others have shown post-repair complications are more common if mesh is used in the repair.

Types of Hernia Mesh

Hernia mesh products include many sizes and shapes for different surgical repairs.

These products include:

  • Patches - A surgical mesh device designed to go over or under the weakened or damaged tissue.
  • Plugs - A surgical mesh device designed to fit inside the hole in the tissue.
  • Sheets - A surgical mesh device designed to be custom fitted for each patient's specific needs.

Each type of hernia mesh may fall into other classifications, for example: absorbable, non-absorbable, coated, synthetic, and animal derived, to name a few.

Absorbable Hernia Mesh

Absorbable mesh will degrade and lose strength over time and is not used to provide long-term reinforcement to the repaired hernia. "As the material degrades, new tissue growth is intended to provide strength to the repair," according to the US Food & Drug Administration.

Non-Absorbable Hernia Mesh

Non-absorbable mesh, on the other hand, is considered a permanent implant, remaining in the body indefinitely. Non-absorbable mesh is intended to provide lasting reinforcement to the repair site.

Synthetic Hernia Mesh

Surgical mesh made of synthetic materials come in woven or non-woven sheets. The synthetic materials can be absorbable, non-absorbable, or a combination of both. The most popular types of surgical mesh are made of synthetic plastic called polypropylene.

Coated or Composite Hernia Mesh

At least one hernia repair technique can leave mesh in contact with the intestines. This can cause the intestines to adhere to the mesh which can result in severe complications. To prevent adhesions, some polypropylene meshes may come coated with absorbable fatty acids, cellulose, or collagen.

Safety Issues

There are over 100,000 hernia meshes implanted every year in the United States. Many of the most dangerous hernia meshes remain on the market and have not been recalled by the FDA. Bowel obstructions and severe infections are common complications related to hernia mesh.

The manufacturers of hernia mesh know of the life-threatening complications their products can cause, but do not warn the public or implanting surgeons. The attorneys at Dalimonte Rueb are able to help educate you on the dangers of hernia mesh.

HERNIA MESH WARNINGS & RECALLS

What causes the complications can vary depending on the hernia mesh product. Many hernia mesh products contain a type of plastic known as polypropylene, the same material that is used to make many types of pelvic mesh and bladder slings that have proven to cause issues.

The FDA has announced several manufacturer recalls, and issued a Safety Communication in 2014, warning the public about adverse events linked to hernia mesh.

Patients injured by hernia mesh have filed lawsuits against the manufactures for knowing the mesh is faulty and poorly designed, and hiding the risks. Companies who issued recalls of their hernia mesh products include Atrium Medical Corporation, Covidien, Bard Davol, and Ethicon.

IVC Filters

Purpose of the Device

The device was introduced in 1979, and its use increased continuously through the years. By 2012, doctors inserted approximately 259,000 filters in patients. Today greater than 2,000,000 IVC filters have been inserted into patients.

The inferior vena cava is the largest vein in the body, moving deoxygenated blood from the lower legs to the heart and then the lungs. In order to prevent blood clots from traveling to the lungs resulting in a life-threatening pulmonary embolisms (PEs), doctors implant an IVC filter in the vein. Retrievable filters are associated with high potential risks such as fracturing or breaking apart in the vein, damaging tissue, migrating into the heart, or failing to stop blood clots from bypassing the device.

The device is inserted by a doctor using a catheter into a patient's inferior vena cava through a small incision in the neck or groin. Metal wires that are part of the device are supposed to capture and trap blood clots before they can reach the lungs.

While some filters are permanent, others are retrievable or temporary. Physicians remove retrievable filters in a similar way that they implant them by first injecting contrast or X-ray dye around the device to make sure it is safe to proceed with the removal. Then a catheter-like snare inserted into the vein is used to grab the hook located on the top end of the filter. The filter is then covered by a sheath and pulled out of the vein through the incision in the neck or groin.

Warnings

Retrievable filters are associated with high potential risks, such as fracturing or breaking apart in the vein, damaging tissue, migrating into the heart, or failing to stop blood clots from bypassing the device. Serious complications can occur as a result of the implanted filters, like when a device breaks apart and travels to another area of the body, otherwise known as device migration, the most common adverse reaction. The FDA listed embolization as the second most frequently reported complication.

Retrievable IVC filters are only intended for short-term placement, and the FDA reported concern about the devices staying in patients long after PE risks subsided. The FDA updated safety communication in 2014, recommending retrievable devices be removed between the 29th and 54th day after implantation in patients in which PE subsided.

Side Effects

Former recipients of retrievable IVC filters filed legal claims against manufacturers for poor design, manufacturing and failing to warn of risks. Faulty filters punctured veins, fractured and migrated to other parts of the body causing complications.

In a report released in 2010, the FDA received more than 900 reports of adverse events associated with IVC filters, including 70 filter perforations, 328 device migrations, 56 filter fractures, and 146 embolisms.

Hip & Knee Replacements

Purpose of the Device

Depending on the age of the patient and the nature of the injury or condition, there are various surgical procedures to consider with the ultimate goal of reducing pain and increasing mobility. The three hip replacement procedures are: total hip replacement, partial hip replacement and hip resurfacing. The patient and doctor may determine that only one, or both, knees require replacement.

Warnings

Hip and knee replacements involve the surgical repair of an aged or injured natural hip joint or knee by adding an artificial joint or implant, and this procedure dates back three centuries. Patients who have undergone hip or knee replacement surgery may experience problems shortly following the surgery or years down the road. Reasons for these implants are the same now as they were then: a fracture or similar injury to the hip, arthritis or a wearing down of the joint over time.

Metal-on-metal hip and knee systems are classified as Class III (higher risk) devices but are regulated under the Food and Drug Administration (FDA) 510(k) premarket notification program. That means they are not required to undergo premarket testing or clinical trials before they are used in patients. Under the 510(k) program, manufacturers simply have to state that their products are similar to products already on the market.

In May 2011, the FDA ordered 21 manufacturers of metal-on-metal products to conduct postmarket studies. A year later, an FDA panel found that there is little reason for surgeons to continue to use metal-on-metal implant systems.

Side Effects

Patients who have undergone hip and/or knee replacement surgery may experience problems shortly following the surgery or years down the road. In most cases, complications stem from the materials used in the implants themselves. Metal-on-metal implants can lead to metallosis, which is a serious condition that occurs when metallic debris builds up in the soft tissue of the body. Osteolysis, another serious complication that can occur following hip and/or knee replacement surgery, is the loss of bone around the implant as the body works to clean up foreign particles that are produced by the device during normal movement. This can lead to loosening and failure of the implant.