Danger: implants.

Area of Science:

• Medical Device Regulation
• Public Health Policy
• Biomedical Engineering

Background:

• The term "medical devices" encompasses a wide range of products, from implants to equipment.
• Approximately 130 categories of high-risk medical devices lack sufficient proof of safety and effectiveness.
• Many of these devices were in use before the Food and Drug Administration (FDA) gained regulatory authority in 1976.

Purpose of the Study:

• To investigate the safety and effectiveness of high-risk medical devices.
• To highlight specific devices undergoing FDA scrutiny.
• To analyze FDA data on selected medical devices.

Main Methods:

• Review of FDA data obtained through the Freedom of Information Act.
• In-depth computer analysis of device data.
• Focus on five high-risk device categories slated for FDA review.

Main Results:

• Saline-filled breast implants, inflatable penile implants, testicular implants, heart-bypass pumps, and cranial stimulators are prioritized for FDA review.
• Computer analysis indicated that penile implants warrant particular scrutiny.
• The FDA is intensifying its regulatory oversight of medical devices.

Conclusions:

• The FDA's enhanced scrutiny of medical devices is a critical step in ensuring public safety.
• Penile implants represent a category of medical devices requiring further investigation.
• The review process aims to address the lack of safety and effectiveness data for numerous high-risk devices.