Breast Implant Injuries Have Traditionally Been Reported in Bulk
In the seven-year span from 2008 to 2015, the U.S. Food and Drug Administration (FDA) publicly reported only 200 or so breast implant complaints annually. However, more than 4,000 injuries were reported in the last half of 2017 and another 8,000 in the first six months of 2018. The data came to light after the FDA instructed device makers to go back and file individual reports in each case of patient injury, in response to an attorney’s discovery that reports from his clients weren’t represented in the agency’s data.
Manufacturers of breast implants have long been required to track patients and their health. However, for many years, those with a high number of recurring problems, including cases in which implants ruptured and required surgery to remove, were allowed to report the issues in bulk. This made it difficult for the FDA to closely monitoring a rare type of cancer, which in 2011, it found might be linked to breast implants.
“They were told those devices were safe — the FDA would go back and say, ‘We only have ‘this many’ reports,’” said Madris Tomes, a former FDA staffer who founded a company to analyze medical device reports. “But data was coming in another way that wasn’t public. It leaves the patients demoralized — they don’t understand how many other people are suffering.”
However, just as the FDA was dealing with the problem of summary reporting, the agency moved to expand the flexibility device manufacturers have in how they reported issues in order to reduce the industry’s paperwork requirements. Just this past August, the FDA began allowing nearly 90 percent of all medical malfunctions to be submitted in a quarterly tally, instead of individually. And, the agency rejected claims that expanding summary reporting could harm public health, saying the plan “will also yield benefits such as helping FDA process malfunction reports more efficiently and helping both FDA and the public more readily identify malfunction trends.”
An emergency room paramedic, Jamee Cook had quit her job because of consistent yet vague health problems that stretched more than ten years, including exhaustion, migraines, trouble focusing, and an autoimmune disorder. “It looked like these devices had become safer, but they hadn’t,” Cook said. “The data was hidden. It’s a deceptive practice.”
Cook removed her textured saline implants and noticed the majority of her symptoms had disappeared. She then became a patient safety advocate, lobbying lawmakers and organizing groups of women online who have concerns about breast implants. Cook is not alone in her quest. Many other women have experienced similiar symptoms.
yet, two of the largest breast implant manufacturers, Mentor and Allergan, said cited years of studies that have led to inconclusive evidence that autoimmune problems are linked to breast implants, and say they stand behind their products. “Our medical devices undergo extensive laboratory testing before they are submitted to government health experts for a science-based review,” Mentor spokesperson Mindy Tinsley said. “Many of our devices undergo careful reviews by not just one, but multiple regulatory bodies around the world.”
Tomes said accurate, complete and publicly accessible data is crucial to identifying problems and making sure devices are safe. The FDA numbers, she said, are not reliable. “You can assume that the numbers are probably much, much higher,” she said.