Each year, the FDA receives medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The Manufacturer and User Facility Device Experience (MAUDE) database houses MDRs submitted by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
From August 25, 2010 through September 10, 2015, the FDA received 258 medical device reports (MDRs) of anaplastic large cell lymphoma (ALCL) in women with breast implants.
Of these reports, 188 were from breast implant manufacturers, 1 was from a user facility, and 69 were from voluntary sources. 45 of these MDRs were verified through pathology, the rest are unverified.
The table below summarizes the data that the FDA received.
|All MDR Reports (as of 9/10/2015)|
|Range||25 – 87|
|Not specified||60 (23%)|
|Time from Implant to ALCL Diagnosis* (yrs)||Median||10|
|Range||1 - 40|
|Not specified||104 (40%)|
|Textured Breast Implant||Yes||129||50|
|Documented History of Both||3||1|
|Silicone v. Saline Fill||Silicone||90||35|
|Reason for Implant||Reconstruction||58||22|
|Anaplastic lymphoma kinase (ALK) negative||Yes||121||47|
* Includes both pathology report confirmed and unconfirmed ALCL Diagnoses.
**MDRs occasionally list more than one clinical presentation i.e. seroma and peri-implant mass
***CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and ALCL
Medical Device Reporting Limitations
MDR reports can be used effectively to:
- Establish a broad overview of adverse events for a specific device or device type
- Detect actual or potential device problems used in a “real world” setting/ environment, including:
- rare, serious, or unexpected adverse events
- adverse events that occur during long-term device use
- adverse events associated with vulnerable populations
- off-label use
- use error
Although MDRs are a valuable source of information, this reporting system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events, and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA's current postmarket surveillance efforts.
Limitations with MDR data alone include:
- MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time, or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the severity, or frequency of problems associated with devices.
- Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.
- MDR data is subjected to reporting bias, attributable to potential causes such as reporting practice, increased media attention, and/or other agency regulatory actions.
- MDR data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making treatment decisions.