Medical devices have evolved at lightning speed over the past decades. They have made a substantial difference in treating sickness, injuries and improving patients' quality of life. The United States has the largest medical device market in the world. The industry is poised for steady growth, with global annual sales expected to rise by over 5 per cent a year and reach near $800 billion by 2030. However, despite being carefully supervised by the US Food and Drug Administration (FDA), a product's design, manufacturing process, or marketing strategy might be flawed.
What is a Medical Device?
The FDA defines a “device” as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- Recognised in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them.
- Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
- Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Defective Medical Devices
There can be unexpected issues with medical devices used in the treatment of patients. Despite strict standards and testing on medical products, these devices can fail or be defective, proving dangerous or life-threatening in some cases. Faults can occur in either the design, manufacture or application of the device. Devices such as cardiac pacemakers and orthopaedic implants can fail or be defective, proving dangerous or life-threatening in some cases. Defective medical devices are designed to improve your quality of life, but when they go wrong, can cause severe injuries and health problems that can drastically affect a person's life.
Common Defective Medical Devices
Operations incorporating artificial components such as joint replacements, heart valves, gastric bands, or cosmetics implants may cause problems if these products have a previously undiscovered flaw. As a result, they must be removed, and in certain circumstances, your health may suffer as a result. This can also apply to surgical instruments and equipment used during an operation.
Da Vinci Robotic Surgery
With the rapid advancements of artificial intelligence, some surgeries are now assisted by robots. In a robotically-assisted procedure, a surgeon uses a robot to manipulate instruments, allowing for more precise control on actions. These robots are used to reduce the stress and fatigue experienced by surgeons, particularly during longer operations. Reports of complications with da Vinci Surgery are extremely rare, but those that do happen can be quite severe. There are numerous potential risks and complications with these robots, including the loss of a large amount of blood, inadvertent cuts, tears or burns and other injuries to organs, tissues or major blood vessels.
Surgical Hernia Mesh
Each year, around one million hernia repair surgeries are performed in the United States. Hernias that are surgically repaired have a significant recurrence risk. Since the 1980s, surgeons have increasingly used hernia mesh to enhance surgical repairs and prevent recurrences. Despite the fact that the FDA has authorised the laparoscopic hernia mesh devices currently on the market, the agency has given cautions regarding potential risks and noted that many meshes have been recalled. Certain hernia meshes are linked to increased risks of infection and other injuries and may require hospitalization and additional surgeries. Some complications reported with these surgeries include:
- Failure of mesh to incorporate tissues
- Mesh failure
- Severe or chronic pain
- Hernia recurrence
- Mesh erosion
- Organ perforation
Transvaginal Mesh Injury
Transvaginal mesh is a surgical patch implanted on the vaginal wall to correct pelvic organ prolapse and stress urinary incontinence. The mesh is used during surgery to support damaged tissue to help with the patient's fast recovery. However, many patients who received it have suffered from mesh erosion and organ perforation.
Paragard Copper IUD
Paragard marketed itself as being the first non-hormonal IUD. It is advertised as a safe, effective, easy method of birth control. However, many women have experienced severe complications from the removal of Paragard and claim that the medical device is defective. It has been known to break, causing damage to the uterus, nearby organs and requires surgery to both take it out and repair the damage.
Metal Hip Replacement
Metal hip replacements are extremely common, with over one million people around the world expected to have metal hip implants. Several models of all-metal hip implants have shown a higher-than-anticipated failure rate, resulting in significant injuries or medical problems for patients. Implant failures and metal poisoning have led to severe medical complications for patients. In addition to the general risks associated with all hip replacement surgeries, with metal hip implants, the metal ball and the metal cup slide against each other during walking or running. According to the FDA, metal can be released from parts of the implant where two components connect. This friction causes tiny metal particles to wear off of the device around the implant, possibly damaging the bone and soft tissue surrounding the implant and joint. High levels of metal in the blood can lead to neurological damage, such as hearing impairment, loss of vision, and depression. Correcting these issues often requires revision surgery, which subjects a patient to further risks and possible complications.
DePuy Hip Implants
Some hip implants have inherent problems with their design, which can lead to high failure rates, metallosis, infection, dislocation, or immobility. DePuy hip implants are a popular brand used in thousands of hip replacement surgeries. However, they have resulted in a large number of patient injuries, with a high failure rate, which has led to recalls and lawsuits.
How we can help
If you or a loved one have suffered medical device complications requiring hospitalization or corrective surgery, you may be entitled to compensation for medical costs and other expenses. It is important to contact a qualified attorney with experience in Medical Device Injury claims in order to ensure you get the compensation you deserve. Our Los Angeles based law firm invites you to contact us for a free, confidential, no-obligation consultation to review your case!