FDA surveillance studies on breast implants

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While there was a dearth of epidemiologic studies on breast implants, there was no lack of reports to the FDA's adverse event reporting systems on breast implants. The FDA receives reports of adverse events on all medical devices through its national reporting program. These adverse events are received from manufacturers, importers, user facilities, and voluntarily from concerned individuals. In order to review all reports on breast implants received by the FDA, three adverse event databases maintained by the FDA were searched. The three databases are:

• Device Experience Network (DEN).

• Manufacturer and User Device Experience (MAUDE).

• Alternative Summary Reporting (ASR).

The DEN database contains FDA's earliest adverse event reports on silicone breast implants. These reports were received under the mandatory Medical Device Reporting (MDR) program during 1984-1997. The reports reviewed were mandatory manufacturer reports on breast implants that may have malfunctioned or caused or contributed to a death or serious injury. Unlike MAUDE (see below), DEN does not contain device or patient problem codes. These codes are from a dictionary of possible device or patient problems [14]. DEN uses causative factor codes instead of manufacturer evaluation and conclusion codes. DEN now serves as an archival database of reports for January 11984-December 31 1997.

The MAUDE database contains reports of medical device adverse events submittedby user facilities since 1992, consumers, importers, and distributors since 1993, and manufacturers since 1996. Distributor reporting was discontinued in 1997. MAUDE has device and patient problem codes, and manufacturer evaluation and conclusion codes. MAUDE is the predominate database used by FDA for evaluation of individual device-related adverse event reports.

The Alternative Summary Reporting (ASR) program was instituted by FDA in 1995 as a means to receive well known and documented adverse events associated with medical devices. ASR allows manufacturers to report these types of events in a concise and condensed report. Under ASR, manufacturers submit a report of injuries and/or malfunctions (depending upon device) to FDA once every 3 months in summarized form, instead of submitting individual reports for each adverse event. In October 1999, new requirements for the ASR program started. With these new requirements, firms now provide patient and device codes as well as evaluation and conclusion codes for each

Table 27.1 Reports to the FDA related to all types of breast implants received, January 1 1984-December 31 2005

FDA database report source

Implant type

Silicone gel-filled

Saline-filled

All types

DEN1

96 954

22 698

119 652

MAUDE2

13 999

9 020

23 019

ASR3

34 794

153 070

187 864

Total

145 747

184 788

330 535

'DEN, Device Experience Network: from a database that was used in 1984-1997.

2MAUDE, Manufacturer and User Facility Device Experience: reports received January 1 1992-

December 312005.

3Alternative Summary Reporting (ASR): these are reports allowed from some manufacturers when large numbers of well-known adverse events or malfunctions are reported. Instead of reporting each event individually, they may send a summary of reports for that particular adverse event or malfunction.

'DEN, Device Experience Network: from a database that was used in 1984-1997.

2MAUDE, Manufacturer and User Facility Device Experience: reports received January 1 1992-

December 312005.

3Alternative Summary Reporting (ASR): these are reports allowed from some manufacturers when large numbers of well-known adverse events or malfunctions are reported. Instead of reporting each event individually, they may send a summary of reports for that particular adverse event or malfunction.

adverse event. Summary reports do not contain narrative text. Instead, each event (or line item as it is called in ASR) is line-listed and summarized by codes.

By the end of2005, the FDA had received 330 535 reports on breast implants from the DEN, MAUDE, and ASR databases combined (Table 27.1). Over the years, the FDA has performed a number of analyses based on adverse event reporting to characterize the reported problems with breast implants. These studies are described below.

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