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Dangerous Medical Devices

Each year millions of people use a variety of medical devices believing they are safe, but they may be poorly designed or manufactured with serious consequences to the user. FDA approval does not guarantee that a device is safe. Unfortunately, there are many examples of manufacturers who knew or should have known their products were dangerous long before they were recalled from the market. Recent examples of dangerous medical devices include:

See examples of our dangerous drugs and medical devices cases.

Metal-on-Metal Hip Implants

Warnings have been issued for problems associated with metal-on-metal hip implants, such as:

  • Biomet M2A and M2A-Magnum Hip Replacement Systems
  • DePuy ASR XL Acetabular System
  • DePuy ASR Hip Resurfacing System
  • Stryker Rejuvenate, ABG II Modular-Neck Systems, and LFIT V40 Femoral Heads
  • Wright CONSERVE® Total Hip Implant System
  • Zimmer Durom Cup

Many patients who have received metal-on-metal hip implants experience significant problems after hip-replacement surgery, including significant pain, swelling, and difficulty walking caused by loosening, fracture, or dislocation. This results in the need for additional surgery to remove and replace the implant. In addition, high levels of metal ions may be released from the implants, causing metallosis (a build-up of metallic debris), necrosis (tissue death), or osteolysis (bone degeneration and death).

In January 2013, the U.S. Food & Drug Administration (FDA) issued a warning for metal-on-metal hip implants, noting that this design was failing at a higher rate than devices constructed of other materials. The FDA advised metal-on-metal hip implant recipients to get blood tests if they experience pain and swelling around the joint, mobility issues, or other signs of a failing implant. The FDA also proposed new rules for metal-on-metal hips, including a requirement that manufacturers conduct safety studies on their current products if they continue to sell them.

A May 2013 Bloomberg.com report stated that the FDA’s scrutiny of metal-on-metal implants prompted a decision by DePuy Orthopaedics to stop selling such devices.

DePuy had already recalled its ASR XL Acetabular System and ASR Hip Resurfacing System in 2010. Design flaws with these implants were known by DePuy for years before the recall. Stryker recalled its two modular-neck components because they can corrode or shed metal where the stem and neck overlap, resulting in tissue damage or metallosis.

In August 2016, Stryker voluntarily recalled select models of its LFIT V40 metal femoral heads. The devices have been associated with corrosion and metal debris, which can lead to serious health consequences and require surgery to remove and replace the hip implant. Diamond~Massong is currently reviewing cases in which revision surgery has been required to replace V40 metal LFIT femoral heads (not C-Taper LFIT heads).

Diamond~Massong has handled many cases involving metal-on-metal hip implants. If you have had problems after hip-replacement surgery with one of the above implants, contact us for assistance.

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Hernia Mesh

A hernia (also called a rupture) occurs when part of an organ or tissue pushes through the wall of the body cavity where it is normally enclosed. This often happens when a weak spot in the muscles or tissue of the abdominal or pelvic wall allows the intestines to stick through.

Many people with hernias require surgery to alleviate daily pain and other symptoms. Hernia repair surgeries are commonly performed but they can have a high recurrence rate. Since the 1980s, surgeons have relied on synthetic hernia mesh to strengthen repairs and prevent recurrences. Over 50 different synthetic meshes are currently used with wide variations in how they are made and labeled.

Synthetic meshes have been linked to an increased risk of infections, adhesions, perforation, or obstruction of the bowels; mesh migration; or a higher-than-expected recurrence rate requiring hospitalization and further surgeries. Some of the synthetic mesh types associated with such problems include:

  • Atrium
    • C-QUR Mesh
  • Bard
    • Composix E/X
    • Ventralex ST
    • 3D Max
    • Sepramesh IP Composite
  • Covidien
    • Parietex Composite
    • SurgiPro Mesh
  • Ethicon
    • Physiomesh

If you or a loved one have undergone a hernia repair with synthetic mesh and have had complications such as revision surgery, bowel repair or resection, adhesions, or infections, please contact Diamond~Massong for more information.

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Surgical Staplers

In May 2019, the U.S. Food & Drug Administration (FDA) issued a Class 1 Recall (the most serious) for Ethicon® Endo-Surgery Curved Intraluminal Staplers due to alarmingly high rates of failures and complications during surgery. In October of 2019, the FDA issued another Class 1 Recall for the Ethicon® Echelon Flex® Endopath® Staplers.

Surgical staples are used to cut and seal blood vessels and tissue. When the staples misfire, or fail to misfire, patients can bleed excessively and suffer catastrophic consequences, even death. The FDA has said that stapler misfunction or misuse can lead to “bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.”

Surgical staples are widely used due to their ease of use. They are commonly used in these types of surgery:

  • Gastrointestinal surgery
  • Colorectal cancer surgery
  • Bariatric surgery
  • Endo-related surgery
  • Gynecologic surgery
  • Urologic surgery
  • Thoracic surgery

Complications from recalled surgical staplers include excessive bleeding, sepsis, organ damage, infection, life-long digestive issues, nutritional deficiencies, leak in the closure, the need for a permanent ostomy “bag,” and even death.

If you underwent surgery and suffered one of these complications, you may have a surgical stapler case. Diamond~Massong has successfully handled many medical device cases. If you believe you or a loved one has been injured by defective surgical staplers, please contact us for assistance.

For more information or to schedule an appointment, please contact us for a free consultation.

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