If you are among the many Americans who received a surgical implant, or if you are considering getting a surgical implant, you might have several questions about the safety regarding certain medical devices. Fortunately, you’re in the right place. This blog answers the most frequently asked questions about medical devices and implants.
Q: What is a medical device?
The U.S. Food Drug & Cosmetic Act defines “medical device” as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar o related article…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, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body…”
Thus medical devices include tongue depressors, gauze bandages, insulin pumps, birth control devices, surgical equipment, and pacemakers. However, medications do not fall under the medical device definition.
Q: What is an implant?
An implant is a type of medical device that is affixed within or on someone’s body. Implants can function as a replacement for body parts (e.g., skeletal structures), used as a pharmaceutical delivery system, or provide functional or structural support for organs and tissue.
Q: How do I know if a device is safe?
The best way to determine a device’s safety is to conduct your own research and make an informed decision. You can start by looking for information about the following issues:
- How long the device has been on the market;
- The number of independent scientific studies about the device;
- How many people tested the device;
- Long-term effects of the device;
- Notices, alerts, or recalls about the device on the U.S. Food & Drug Administration website; and
- Alternative treatments to implantation.
Q: Can’t I remove the implant if something goes wrong?
Depending on the implant, removal may not be a simple procedure. In some situations, removing the defective implant could be even riskier than keeping it. That is why it is critical to research about the removal process for implants in the event they are found to be defective.
Q: Can you tell if a doctor has a personal interest in the recommended medical device?
You can look for your doctor in the Center for Medicare & Medicaid Payments database. There you can find information regarding the doctor’s affiliation with other medical providers, including speaking engagements, consulting, travel, and royalties.
Q: What should I ask my doctor about the implant?
Not all implants are hazardous. Doctors may recommend an implant as the best medical option under the specific circumstances relevant to your medical situation. With that said, not all implants are free of risks. However, if you are concerned about safety, you should ask your doctor for more information. Ideally, you would be comfortable asking your doctor about certain questions regarding their experience and history performing the implantation procedure questions – and they should be just as comfortable answering them. It would help if you also asked about any reported risks or side effects associated with the implant, and the difficulty of removing the device in the event dangerous complications arise.
Q: What do I do if I think my implant is causing problems?
You should contact the medical providers who were responsible for performing the implant procedure. Otherwise, you should contact your primary care physician. He or she can refer you to a specialist with expertise regarding the device and the surgical procedure used to implant it.
Q: Who is legally responsible for my injuries caused by the implant?
If you were injured because a doctor did not perform the surgical procedure properly, the doctor might be liable for malpractice. However, if your doctor performed the procedure correctly, but the device is defective, the manufacturer may be liable to compensate you for your injuries.
Q: Whom should I consult about legal action regarding my injuries?
You should consult a qualified unsafe medical products attorney in Cleveland for answers about the legal options available to you. At Spangenberg Shibley & Liber LLP, we have experience with products liability litigation, including dangerous medical device and implant cases. You can count on us to provide you with sound legal advice and advocacy to help you understand your legal rights. After investigating the essential legal issues regarding your injuries, we can guide you through each step of the litigation process, should you decide to pursue a legal remedy for your injuries. Our legal team is dedicated to fighting for your right to be made whole for your injuries.Contact Spangenberg Shibley & Liber LLP online , or call us at (216) 600-0114 to schedule an appointment with one of our experienced attorneys today.