FDA challenged over metal implants ‘public health travesty’
|Patients who suffered debilitating immune reactions after being implanted with metal-containing devices have joined doctors, scientists and industry representatives to testify before a United States government advisory panel probing the risks of immunological responses to metals placed inside the body.
The hearing represented the most systematic look by the U.S. Food and Drug Administration at the issue of adverse reactions to metals, a problem that affects a minority of implant patients but one that can cause severe pain, neurological damage and cognitive impairments.
|Madris Tomes, an expert on FDA adverse events data, testified that metal-on-metal hips were by far the most commonly cited product in reports of immune and allergic reactions to devices, according to her analysis of FDA data collected in her proprietary Device Events database.
The next most frequently cited devices, she said, were Essure and other types of hip implants such as metal-and-polymer implants.
It is unlikely to result in the short term in dramatic steps such as banning products from the market.
Experts urged the FDA to make the hearing the beginning of a sustained effort to gather data on the problem of metal reactions, including their differential effects among patients of different gender, age and socioeconomic status.
For example, the substantial majority of adverse responses to metal devices occur among women, who are generally more vulnerable to auto-immune, rheumatic and thyroid disorders.
“There’s a need for more and better pre-market research,” said Diana Zuckerman, the president of the National Center for Health Research. “We need to really have better data on diversity of patients.”
|Chavkin S||ICIJ, Implant Files, Nov 14 2019|
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