Navigate to…

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.

Top

Hernia Mesh

Many people with hernias require surgery to alleviate daily pain and other symptoms. Diamond~Massong is currently reviewing cases of people who have had complications or need revision surgery because of polypropylene mesh used to strengthen weakened or damaged tissue in hernia repair, including Ehicon Physiomesh Flexible Composite Mesh or Atrium’s C-QUR surgical meshes. Complications include hernia recurrence, severe or chronic pain, bowel obstructions, infections, mesh migration, adhesions, and other complications that have caused the mesh to fail or have required additional surgery to remove and replace these devices.

In May 2016, Ethicon voluntarily recalled its Physiomesh hernia mesh product from the market after two unpublished studies showed a higher failure rate of this mesh product compared to other, similar hernia repair devices. The FDA’s Canadian and Australian counterparts posted notifications of the voluntarily recall in June 2016.

Diamond~Massong is currently reviewing cases involving severe complications from hernia mesh.

Top

Power Morcellation Surgery

First approved by the FDA in the mid-1990s, power morcellators are widely used in minimally invasive (laparoscopic) hysterectomies and fibroid-removal surgeries. These small bladed devices allow surgeons to cut the uterus or fibroid tissues into small parts so they can be easily extracted through laparoscopic suctioning. However, for women who may have undiagnosed cancer, there is a serious risk the device may spread cancerous cells inside the body. A new study published in a leading medical journal reaffirms a growing body of literature that suggests this danger is much worse than previously recognized.

In addition to spreading cancerous tissues known as uterine sarcomas hidden within fibroids throughout the abdominal cavity, power morcellation can cause the spread of even benign fibroid or uterine tissue throughout the abdomen and pelvic cavity, causing pain, infection, or bowel obstruction as the tissue adheres to and grows on other organs. The FDA’s Obstetrics and Gynecology Devices Advisory Committee recommends that power morcellation not be used on women who are peri- or post-menopausal with new or symptomatic fibroids or on women with a known or suspected malignancy.

Diamond Massong is currently investigating legal claims involving women who have received a cancer diagnosis or have required removal of fibroid tissue growing on other organs after undergoing a hysterectomy or fibroid removal surgery.

Top

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

See what others are saying…

“On a scale of 1 to 10, Maria Diamond is easily a 20! She stays on top of the issues at hand and is very aggressive in making sure her client’s best interests are achieved.” Theresa Wren
Auburn, WA

More testimonials +