FDA's 510(k) Clearance Does NOT Lead to Safer Gyn Medical Devices

Jane Akre
April 11, 2018
Medical Device Safety Being Reviewed

Mesh Medical Device News Desk, April 11, 2018 ~ The Food and Drug Administration's 510(k) clearance process for medical devices has been called a fast-track to market clearance process. This study reveals it does not lead to safer gynecologic medical devices.

FDA Approval of Gynecologic Medical Devices

Image: Desara mesh by Caldera Medical

Latest 2018 Study: Does A 510 K Approval Mean A Medical Device is Safe?

This study was published this week in the Journal of Minimally Invasive Gynecology, by doctors at Rush University Medical Center in Chicago.

It reports the recall rate for 510(k) cleared gynecologic medical devices is 13.6 times the rate of PMA devices. That results in an increased risk to patients.

Sheena Galhotra, MD, tells Mesh News Desk that the Lumenis VersaCut Tissue Morcellator was among the worst devices. Unless a user set up the tubing in a certain way, it could cause an air embolism. The FDA issued a Class I recall in January 2013. See it here.

Lumenis has the VersaCut among its family of products it sells in 2018.

It was approved in March 2005 under the Food and Drug Administration's 510(k) clearance process.  See the 510(k) clearance here.

In the study, 685 medical devices were cleared by the pre-market approval process (PMA), a more stringent clearance that requires proof of patient safety and efficacy through clinical trials, versus the 1,564 medical devices that were cleared through the 510(k) clearance to sell process.

The 510(k) does not require clinical trials. It does require a manufacturer name a "predicate" devices already on the market that the new device is substantially similar to.   MND has reported that the material and construction can be different, but the predicate device can still be named.  Also the FDA has no system in place to re-review devices approved when a predicate is recalled from the market for causing patient harm.

Gynecare Prolift, from FDA premarket approval documents
Gynecare Prolift, from FDA documents

Transvaginal mesh, whether TVT, TVT-O or pelvic organ prolapse meshes, made from polypropylene, biologics, or composites, are all cleared through the 510(k) process.  Learn more about 510(k) here.

In all, 1.17% of the PMA approved devices and 15.98% of the 510(k) cleared devices were recalled.

The number of recalls with PMA approved devices did not change over time while there was an increase in recalls among the 510(k) cleared medical devices.

While industry often urges lawmakers to allow the FDA to clear more devices faster, researchers here conclude this evidence calls for improvements and increase scrutiny of the 510(k) approval process for gynecologic medical devices.



Mesh medical device after removal
Mesh medical device after removal

J of Minimally Invasive Gynecologic Surgery, Assessment of Obstetric and Gynecologic FDA Device Approvals and Recalls, April 2018

MND, 510(k) approval process

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