Out of Control: The Dangerous Health Business
In this documentary, DW investigates the EU’s medical device industry. The filmmakers maintain that medical complications caused by defective devices have increased by 300% in the EU and 1500% in the US, where regulation is even more lax.
The principal devices DW looks at are pacemakers, replacement hips, breast implants, insulin pumps, transvaginal mesh stabilizers and plastic spinal disk replacements. Reported complications include the failure of pacemakers to prevent fatal arrythmias, insulin pumps that accidentally overdose patients on insulin, and breast and orthopedic implants that rupture, leading to cancer, severe chronic pain and other serious complications.
The EU fails to rigorously enforce companies’ reporting requirements when patients and doctors discover defects in their products. Worse still, the EU allows some companies to bring medical devices to market without any clinical trials at all.
A German Member of the European Parliament (MEP) has recently introduced a bill that would create a government certification program for all new medical devices. At present the EU allows manufacturers to hire private certifying companies to approve the safety of their products.