Dubious devices?

An unpublished FDA report faults a dozen types of devices that won approval in Europe.

• PleuraSeal to seal lung incisions.

• Trilucent breast implants.

• Stent grafts to repair aortic aneurysms (many manufacturers).

• Elbow implant (device not named).

• Cardiac constraint devices to treat congestive heart failure (including CorCap).

• More than 160 dermal fillers.

• At least 12 brands of patent foramen ovale occluders.

• CoStar drug-coated stent.

• Biofield breast cancer detector.

• RoboDoc femur drill.

• Zephyr emphysema treatment valve.