The Food and Drug Administration (FDA) is responsible for ensuring the safety of medical devices on the market, including those used for surgical implants. When a device is discovered to have a defect that may pose a danger to a person, it is recalled, which means it is removed from the market.
Unfortunately, thousands of people who have already received medical device implants have had bad news recently: their device has been recalled—devices like those used in hip, knee, elbow, and shoulder joint replacement surgeries. Devices like surgical mesh are used in hernia repair, vaginal surgeries, and other abdominal procedures. The only answer for those who received a recalled device is to have a second surgical procedure to have it removed. Otherwise, they have to live with the implanted device and any unfortunate results that may come with that decision.
How Serious Is the Medical Device Recall Problem?
There are three different levels of recalls, but when a device is recalled at any level, the FDA is saying that a problem has been discovered and that the device is not meeting the performance standard required by law. In the first quarter of 2018, more devices did not meet that standard than at any time since 2005 and were recalled.
Recalls for the first quarter of 2018 increased an alarming 126 percent over the last quarter of 2017. A cardiologist at the University of California, San Francisco, Dr. Rita Redberg, was interviewed by Drugwatch and expressed her concern that the report of the recalls may be just “the tip of the iceberg.” She is worried that there may “a lot more adverse events associated with devices on the market that we’re not hearing about and should be.”
Dr. Redberg is also concerned that the government process for identifying “adverse effects” of a device is inadequate. She adds that “We only hear about a few percent of what actually happens.”
According to the released report, a total of 208.4 million medical device units were recalled in the first quarter of 2018. Nearly 94 percent of the recalls were due to defects that occurred during the manufacturing process. Those who have had such a device implanted will receive a notice indicating that there has been a “failure” with their device, and they should consult with their physician to determine the next steps.
Common Medical Devices Involved in Recalls
Medical device recalls can affect a wide range of products, including those used in everyday surgeries and treatments. Some of the most commonly recalled devices are:
- Joint replacement implants, including those for the hip, knee, shoulder, and elbow, are often recalled due to issues such as loosening, early failure, or the release of harmful metal debris.
- Surgical mesh: Used in hernia repairs and other procedures, surgical mesh may be recalled for risks of tearing, infection, or improper implantation.
- Pacemakers and defibrillators: These life-saving heart devices can be recalled for electrical malfunctions or battery failures.
- Infusion pumps and catheters: Are Used for medication delivery and may be recalled due to leaks, dosing errors, or contamination.
If you have one of these devices and have received a recall notice or are experiencing complications, contact your doctor immediately to discuss your options.
What Should I Do If My Medical Device Is Recalled?
If you receive a notice that your device has been recalled, follow these three steps. The first thing is to visit your doctor. You may require a second operation to remove the device, or you may decide to live with it, aware of the risks and potential side effects that may be unpleasant or even dangerous. Surgical removal is a very serious event. For some devices, particularly joint replacement devices and surgical mesh, removing all the metal pieces involved may be impossible.
One example of metal problems associated with device removal is demonstrated by at least one hip replacement device, which was found to be defective because the movement of the joint caused friction within the device, leading to metal fragments becoming loose and entering the bloodstream. In addition to the problems associated with a second surgery to remove the device, many patients also suffered from metal poisoning.
The second step is to contact your insurance company to determine the coverage you will have for any surgery required due to the recall of your device. Finally, contact an attorney who is experienced in product liability litigation.
How a Chicago Medical Device Attorney Can Help You Recover Compensation
Litigation may be necessary for you to recover damages. This may include compensation for:
- Costs of a procedure performed to remove the defective device and for the surgeon to install a new device, if possible.
- Any future medical treatment or surgical procedures that will be necessary due to any complications that may arise from the defective device.
- Lost wages and future earning capacity.
- Pain and suffering.
- Loss of your enjoyment of life.
- Any economic loss suffered due to problems you incur because of the defective device.
If you have received a notice that your medical device has been recalled, call the medical device attorneys at the Blumenshine Law Group at (312)766-1000. We have years of experience helping those who have suffered due to defective medical devices. We offer a free consultation, during which we can review the specific circumstances of your case, explain the law to you, and determine whether we should pursue litigation on your behalf. Contact us as soon as possible.