Medical advances happen frequently in our modern world, often resulting in new medical devices on the market. These range from artificial hip joints to heart valves to mesh that helps complete a surgery, making medical devices increasingly popular. In fact, about 32 million Americans, or roughly ten percent of the US population, use an implanted medical device. As beneficial as these devices can be, they can also cause harm if they malfunction.
Regulation of medical devices is a complex issue with certain loopholes that make approval easier in some circumstances. The responsibility of regulating these devices lies with the U.S. Food and Drug Administration (FDA). However, manufacturers can pursue expedited approval through a process called the 501(K) pathway if their device is similar to one already on the market. Unfortunately, this accelerated approval process may result in devices being approved with limited scrutiny. Additionally, a “similar” device may still have differences that make it more likely to cause unintended issues than the original. For these reasons, some medical devices that receive approval are later found to cause dangerous side effects.
How Do You Know If You Need a Salt Lake City Defective Medical Devices Attorney?
Sometimes people become aware very quickly after their medical device has malfunctioned. For example, if you were diabetic and your insulin pump stopped working correctly, you could quickly find yourself in a blood sugar crisis. But not every medical device malfunctions in such a clear-cut way. A defective hernia mesh implant, for instance, could slowly degrade over months or years, causing confusing symptoms such as intermittent pain. Some patients with defective medical devices may struggle for years to get a diagnosis of their symptoms. Additionally, a medical device can work as intended while still having unintended, serious side effects.
If you suspect a defective medical device harmed you, it’s a good idea to consult a lawyer. Your personal injury attorney in Salt Lake City can help you determine if you were the victim of a defective product and, if so, what your options are for pursuing compensation. If we find evidence the device caused you serious harm, you may be able to recover damages such as medical expenses, lost income or earning potential, permanent disability or disfigurement, pain and suffering, or damages associated with wrongful death.
What Are Some Signs of a Defective Medical Device?
Here are some signs you should be concerned about if you use a medical device:
Severe Pain
Some pain is normal after surgery or a procedure, but if your pain doesn’t improve in a reasonable amount of time, doesn’t respond to medication or other treatments, or gets worse with no obvious cause, you could be experiencing a problem with a defective medical device.
While some people experience unrelenting pain from a medical device almost immediately after it’s implanted, that isn’t always the case. Sometimes patients don’t connect their pain to a medical device because it didn’t begin until months after they started using the item. If you have a medical implant anywhere near the site of your pain, it’s worth asking your doctor if your device could cause the symptoms. But remember that some defective devices can migrate, so you could still have pain in areas far away from the original implant site.
If you do begin having pain shortly after an implant is placed, speak with your doctor about when the pain should start to get better and check back in if it doesn’t. Sometimes doctors brush off a patient’s concerns in these situations, so you may need to seek a second opinion if your physician insists on ignoring your symptoms. It’s important to get to the bottom of your pain because, in some cases, you may have been injured by a doctor’s error in surgery rather than a defective medical device. In either case, your attorney can help you seek compensation once you’ve gotten a firm diagnosis.
Unusual Bleeding or Bruising
Sometimes a defective device can cut into nearby tissues, causing pain and also bleeding. If the device is dislodged and travels through the body, it can do even more damage. Patients experiencing internal bleeding may notice unusual bruising or darkening of the skin and, depending on the device’s location may have external bleeding in some cases. For example, defective transvaginal mesh used in some bladder and gynecologic surgeries can migrate, causing persistent or irregular bleeding.
Mobility Issues
Many medical devices, including artificial joints, are intended to help the patient move more easily. However, it can take some time after the surgery for patients to work their way back to their pre-surgery levels of mobility. The recovery time for a knee replacement, for example, is about twelve weeks on average. It’s also important to remember that you’ll get the best results from your new joint if you follow your doctor’s instructions for physical therapy – this allows you to recover as much function as possible.
But if you’ve taken all your doctor’s and physical therapist’s advice, completed your prescribed therapy, and still have very limited mobility with a new joint or other device, you may have a defective device. Ask your doctor if there are any tests they can do to diagnose the problem.
You Still Use a Recalled Medical Device
In a perfect world, manufacturers would voluntarily recall devices after identifying a pattern of consumer complaints. But in the real world, this doesn’t always happen. In fact, some manufacturers may go out of their way to conceal a problem with their product. Consumers may also complain to the FDA, but it can take a large number of reports for this organization to take action and order a recall.
If a recall does happen, depending on the type of recall, you may or may not be notified. In the most serious incidents, where it is believed that the devices pose an imminent threat to users, the FDA will try to track down each patient who received a defective device and notify them. But in less serious situations, they may not do this. Sometimes recall notices go out in a mass mailing, and some get lost in the mail or never reach the intended recipient due to a change of address or other reasons.
The bottom line is that you may or may not know if your device was recalled. If you suspect a problem and know the name of your device, you can search online to learn if it was recalled. Your doctor should be able to give you the specific model number of your implant if asked.
Remember that just because your device hasn’t been recalled doesn’t necessarily mean it’s safe. As we discussed earlier, it can take numerous complaints and multiple years before a device is recalled, and someone is always the first person to experience a problem. Never stop advocating for yourself and trying to get answers.
Any Unexplained Symptoms
If you have any symptoms that your doctor can’t find a diagnosis or treatment for, and they began after you started using a medical device, it’s worth considering if there could be a connection. Keep in mind that your doctor may tell you there isn’t one. However, if the doctor also can’t find a reason for your symptoms or brushes them off as “stress,” you might look at the product reviews to see if other people have experienced symptoms similar to yours. While anyone can write anything in a product review, if you notice a pattern of people describing the exact same symptoms you had, it’s possible there is a connection.
Even if your doctor doesn’t think the device is causing your issues, you can still ask if it’s feasible to try a different solution – but don’t stop using your device without talking to your healthcare provider. In some situations, you may be able to try a different device that works without serious side effects.
What to Do If You Suspect a Defective Medical Device
Continue to pursue a diagnosis for your symptoms and, if possible, try a different device to see if you feel better. If you can remember, try to write down when your symptoms started, how they progressed, and the steps you took to get answers – seeing different doctors, tests you had, treatments you tried, etc. Gather your medical records, and contact a defective medical devices lawyer to learn more about reporting a defective medical device.
Where Can You Find an Experienced Salt Lake City Defective Medical Devices Law Firm?
Please contact Valley Law Accident and Injury Lawyers at 801-810-9999 for a free consultation about your case. We’ll review your records and look into the device. In some cases, we may investigate further and consider if there is enough evidence to pursue a case against the manufacturer. If so, we will fight tirelessly to get you the compensation you deserve.
Founder and lead attorney Brigham Richards believes every client is his most important, and that responsibility is a cornerstone of his law practice. He works every day to help injured clients seek justice for their injuries and pursue compensation to assist them in their recovery. Mr. Richards also speaks English and Spanish fluently.
