Implant Eruption Sparks FDA Reform Debate
Tonya Brand experienced a severe medical device malfunction when a metal wire from an IVC filter, implanted in her abdomen to prevent blood clots, erupted from her leg. The filter, placed in 2009, had broken apart, with another shard lodged near her spine. Brand's lawsuit against Cook Medical revealed undisclosed safety concerns, including deaths and perforated veins in trials, which were previously kept confidential.