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The findings of researchers with a non-partisan think tank suggest that most medical devices currently being used on patients were never sufficiently tested for safety and effectiveness before they were introduced.
In a report published by the medical journal JAMA Internal Medicine, researchers with the Pew Charitable Trusts warn that the majority of FDA approved medical devices that are classified as high to moderate risk do not have publicly available scientific data that shows they are either safe or effective.
Critics have complained that in many cases, the FDA approves products and then requires the manufacturers to conduct postmarketing surveillance studies, known as postapproval studies (PAS). However, it appears that the companies typically begin selling their products after getting the FDA approval, but simply do not complete the studies.
Researchers with the Pew Charitable Trusts suggest that most of the time the FDA does not even ask for the postapproval studies and does little in the way of oversight of those studies. The report found that from 2005 through 2011, the FDA ordered 223 studies for 158 medical devices. Only 48% of those devices deemed high risk were subject to such a study.
“The FDA has never issued a warning letter or penalty owing to study delays, inadequate progress, or any other issue related to a PAS,” the researchers determined. “Postapproval studies have the potential to provide additional information to better understand medical device performance. However, small sample sizes, delays in reaching protocol agreement, and lack of availability of findings may hinder their ability to be clinically useful.”
Even with those limitations, and a lack of studies being requested or actually done, the study still found that the FDA required a label change as a result of 53% of the PAS findings.
Many medical devices are fast-tracked through the FDA’s 510(k) approval process, which allows devices deemed “substantially equivalent” to existing medical devices to the market with little to no clinical testing.
The agency has received criticism for expanding the definition of “substantially equivalent” to products that advertise using new technologies and techniques, which are radically different from their predecessors.
Many critics say that since the program’s inception in the 1980s, the term “substantially equivalent” has become nearly meaningless.
At the same time, many medical device manufacturers have been obtaining approval for devices like hip replacements and transvaginal surgical mesh by claiming they are nearly identical to previously approved devices. They have engaged in marketing that extolled the virtues of the devices, claiming that they are vast improvements that utilize “revolutionary” designs or new materials never before used in previous devices.
Originally designed for non-critical medical devices, such as band-aids and tongue suppressors, the program has expanded over the years to include numerous medical implants, including surgical mesh, artificial joint implants, defibrillators, stents and other critical devices that are permanently implanted into the human body.
The program has come under increasing fire over the last several years, due to the number of recalls involving 510(k) approved devices, which were only found to carry unacceptable risks after they had already been implanted in thousands of patients.
On July 28, the FDA issued new guidance on which medical devices should be considered substantially equivalent to older devices.
Power Morcellator Concerns
The issue came up again most recently at an FDA advisory committee hearing over power morcellator cancer risks.
Power morcellators are medical devices introduced over the past decade for use during a laparscopic hysterectomy or myomectomy for uterine fibroid surgery. The devices cut up the uterus or fibroids into small pieces, which doctors are able to remove through a small incision in the abdomen, reducing the risk of surgical complications and minimizing recovery time.
After the devices gained wide-spread use in hundreds of thousands of procedures, the FDA issued new warnings in April 2014, urging doctors to stop using power morcellators due the risk of spreading cancer.
Several weeks ago, Johnson & Johnson’s Ethicon division, which controlled more than 70% of the morcellator market, issued a power morcellator recall and announced that it was exiting the business of manufacturing the devices since there may be no way to make them safe.
The FDA determined that many women who undergo the procedure have undiagnosed forms of uterine cancer, like sarcoma and leiomyosarcoma. The morcellators inadvertantly can spread the cancerous cells around inside the woman’s body cavity, immediately advancing the cancer from its earliest, most treatable stages, to its most dangerous and deadly with no warning that the woman even had cancer.
At the hearing, Dr. David R. Challoner, chairman of the Institute of Medicine (IoM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process noted that the power morcellator was another child of the 510(k) program that had avoided premarket testing. The FDA is now weighing recommendations to either place a black box cancer risk warning on all power morcellators, or to issue a power morcellator recall and ban the devices from use during uterine fibroid removal.