Medical device manufacturers continue to make truly remarkable strides in improving quality of life for all of us, but not every new product will have all the results its designers intended. This means some devices, while still approved for use, may require additional caution when considering them.
Patient9 continually scours the medical literature for concerns regarding the safety of implantable and wearable devices that could affect you. Numerous research and advocacy groups report selectively on such safety matters. We have found the Food and Drug Administration (“FDA”) to be the most authoritative repository of such reporting.
The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a valuable resource for tracking and identifying potential safety concerns with medical devices. The database contains reports of adverse events involving medical devices, submitted by manufacturers, user facilities, patients, and healthcare professionals.
While the MAUDE database does not necessarily indicate that a device is unsafe, it can be used to identify devices that may warrant further investigation. The FDA regularly reviews the MAUDE database for potential safety concerns and takes appropriate action, such as issuing safety alerts or requiring manufacturers to take corrective action.
Here is a list of some medical devices that have been noted to have safety concerns, based on the FDA MAUDE database:
Implantable mesh devices are used to treat a variety of conditions, including hernia, pelvic organ prolapse, and stress urinary incontinence. However, the MAUDE database contains reports of serious adverse events associated with these devices, such as infection, pain, and erosion through tissue.
Here is a list of some of the medical device manufacturers and their product models with the most reports in the MAUDE database for this product category:
- Ethicon Physiomesh
- Bard Pelvic Mesh
- Boston Scientific Pinnacle
- C.R. Bard Composix Kugel Mesh
Metal-on-metal Hip Implants
Metal-on-metal hip implants were once thought to be a durable and long-lasting solution for hip replacement surgery. However, the MAUDE database contains reports of serious adverse events associated with these devices, such as metallosis (poisoning of the blood with metal ions) and dislocation.
Here is a list of some of the medical device manufacturers and their product models with the most reports in the MAUDE database for this product category:
- DePuy ASR
- Stryker Rejuvenate
- Wright Conserve
Transvaginal Mesh Devices
Transvaginal mesh devices were used to treat pelvic organ prolapse and stress urinary incontinence. However, the MAUDE database contains reports of serious adverse events associated with these devices, such as pain, infection, and erosion through tissue.
Here is a list of some of the medical device manufacturers and their product models with the most reports in the MAUDE database for this product category:
- Johnson & Johnson TVT
- Ethicon Prolene Mesh
- Boston Scientific Advantage
- C.R. Bard Avaulta
Pacemakers and Implantable Cardioverter Defibrillators (ICDs)
Pacemakers and ICDs are implanted devices that help to regulate the heart’s rhythm. However, the MAUDE database contains reports of serious adverse events associated with these devices, such as device failure, infection, and lead displacement.
Here is a list of some of the medical device manufacturers and their product models with the most reports in the MAUDE database for this product category:
- Medtronic SynchroMed
- St. Jude Medical Durata
- Boston Scientific Advisa DR
- Abbott Guidant Contak Renewal
Breast Implants
Breast implants are used for breast augmentation and reconstruction. However, the MAUDE database contains reports of serious adverse events associated with these devices, such as rupture, capsular contracture, and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Here is a list of some of the medical device manufacturers and their product models with the most reports in the MAUDE database for this product category:
- Allergan Natrelle
- Mentor MemoryGel
- Sientra Motiva
- Johnson & Johnson Natrelle Saline
It is important to note that this list is not exhaustive and that there may be other brands and product models with safety concerns. It is also important to note that the MAUDE database does not necessarily indicate that a device is unsafe.
However, if you are considering using a medical device, it is important to talk to your doctor about the risks and benefits of the device and to search the MAUDE database for information about specific devices.
If you have experienced an adverse event associated with a medical device, you are encouraged to file a voluntary report by phone at 1-800-332-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.
