Defective Medical Device Recalls 

When a medical device is either defective, a health risk, or both defective and a health risk, the manufacturer must “recall” the product by taking action to address the problem. However, a recall does not always mean that the product must be sent back to the company; it may simply mean that the product needs to be examined or altered. The U.S. Food and Drug Administration (FDA) reviews the company’s action by classifying the recall into one of three categories indicating the degree of risk. 

Class I Medical Device Recall

When there is a reasonable likelihood that a defective medical device will cause significant health problems or death, the FDA classifies it as a Class I Medical Device Recall.

Class II Medical Device Recall

If there’s a possibility that a defective medical product can cause a temporary or reversible health issue, or if there is a small chance that the device will lead to severe health problems or death, the FDA classifies it as a Class II Medical Device Recall.

Class III Medical Device Recall

When a defective medical product is unlikely to cause health issues or injuries, the FDA classifies it as a Class III Medical Device Recall.

Hip Implants 

Hip implants are either plastic or metal artificial joints. Typical reasons for a hip implant are severe hip pain, or the patient suffers from osteoarthritis. When a hip implant is defective it may fail or spread toxic metal to the surrounding tissue in the patient’s leg. Such failure may result in pain, swelling, or metal poisoning.  

There have been many hip replacement implant devices which have been recalled including hip implants or hip implant parts made by:
  • Stryker
  • Zimmer
  • Smith & Nephew
  • Biomet

Power Morcellators

A power morcellator is a device used during minimally invasive medical procedures to cut tissue into pieces that can then be easily removed through a small incision. Power morcellators have become an increasingly popular device as they can make an otherwise intensive surgery both less invasive and less risky. However, power morcellators, particularly in cases of hysterectomies and myomectomies, have been found to spread cancerous tissue leading to serious illness and lawsuits against their manufacturers. 

Transvaginal Mesh 

Patients who suffer from pelvic organ prolapse (POP) use transvaginal mesh to support their weakened uterine wall. It is also used for cases of hernias and stress urinary incontinence (SUI).

If the transvaginal mesh is defective, the patient may suffer from:
  • Loss of bladder control
  • Severe discomfort
  • Painful sex
  • Nerve damage
  • Infection
  • Vaginal scarring

Hernia Mesh

Hernia Mesh is used to support damaged tissue surrounding a hernia as it heals. Defective implants may be rejected, migrate, or cause adhesion, erectile dysfunction, infection, or bowel obstruction.

Essure 

Essure is a permanent birth control device implanted in the fallopian tubes to prevent fertilization in the uterus. Users may suffer from abdominal pain or menstrual cramps, and there is a risk of perforation of the uterus or fallopian tubes.

IVC Filters 

IVC filters are often implanted in patients who are prone to blood clots in order to prevent clots from traveling to other areas of the body. These filters can fail, drift, break or become lodged, causing injury or death.  

If you have been injured by a defective product, including any of the products listed above, we are here to help. Call 866-465-1419 or fill out the form below to speak with a premier defective medical device lawyer today. 

Who Can Be Held Liable in a Defective Medical Product Lawsuit? 

In a defective medical device lawsuit, claims may be brought against a variety of actors who were involved in the creation or shipment of the defective medical device. An experienced defective medical device lawyer can determine which, if any, parties may be held responsible.

Potential defendants include:
  • Hospitals and clinics
  • Manufacturers
  • Medical sales representatives
  • Doctors
  • Testing laboratories
  • Retail suppliers

What Damages Can I Get From a Defective Medical Device Lawsuit? 

In a defective medical device lawsuit, a victim of defective medical products can be eligible for monetary awards including:
  • Reimbursement of medical bills
  • Compensation for subsequent medical procedures
  • Lost wages

Get Help Today From a Leading Defective Medical Device Lawyer

Defective medical device settlements and lawsuits often involve complex matters, so it is highly recommended to obtain the help of an expert defective medical device attorney. For more information or to be matched with a defective medical device lawyer, call us at 866-465-1419 or fill out the form below.

The Law Center 

If you have been the victim of injuries caused by a defective medical product, The Law Center can help by connecting you with one of the top defective medical device law firms in the United States. Call 866-465-1419 or fill out the form below to get started today.

Sources

  1. https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6540255/
  3. https://www.fda.gov/medical-devices/implants-and-prosthetics/hernia-surgical-mesh-implants
  4. https://www.fda.gov/medical-devices/surgery-devices/laparoscopic-power-morcellators
  5. https://www.fda.gov/medical-devices/metal-metal-hip-implants/concerns-about-metal-metal-hip-implants
  6. https://www.fda.gov/medical-devices/implants-and-prosthetics/urogynecologic-surgical-mesh-implants