Washington, DCToo many women who have suffered transvaginal mesh complications wonder how it was ever approved by the FDA and why it took the agency so long to classify the mesh as a high-risk medical device. And when TVM victims find out, they are furious at both the FDA and the mesh makers.
A recent study published in Obstetrics and Gynecology (May 4, 2016) by Northwestern University researchers criticizes the FDA for approving a number of high-risk women’s health devices, including transvaginal mesh, based on weak clinical studies.
“Although it is impossible to know retrospectively whether more rigorous regulation would have prevented complications associated with [transvaginal mesh], it may have provided earlier warning of patient safety risks,” said lead researcher Dr. Steve Xu.
Transvaginal mesh was approved under a fast-track FDA process that deemed it similar to older mesh products. In fact, about 90 percent of medical devices sold in the United States are cleared under this 501(k) process, which is “a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval,” according to the FDA website. But the new mesh devices were not similar to the older types.
It took the FDA until the beginning of this year to classify the transvaginal mesh as a class III, or high-risk, medical device. Manufacturers will now be required to submit premarket approval applications demonstrating the safety and effectiveness of their products. Devices posing the highest potential risk to patients, such as pacemakers, must submit enough clinical data to the FDA that demonstrates safety and effectiveness. Transvaginal mesh was approved by the fast-track process and did not require so much clinical data. But it now falls into the same category as life-support or life-sustaining devices - e.g., pacemakers and heart valves.
From the FDA’s database, the Northwestern researchers studied 18 high-risk devices that were approved between 2000 and 2015. Of the 18, four devices did not demonstrate effectiveness, six were not required to conduct post-marketing safety studies, and three have been withdrawn from the market by makers because of safety or other problems.
“Device regulation is just so much weaker than drug regulation, and it doesn’t make any sense,” said Dr. Xu.
“The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?”
Xu also voiced concern that the 21st Century Cures Act - legislation that has passed the House and is being considered in the Senate - would make device regulation even weaker. Critics of the Act say that it would speed up medical “innovation” by weakening the FDA and its standards for drug and medical device approval. And it would increase pharmaceutical companies’ profits. They will no doubt need increased profits to cover increased medical device lawsuits.
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