LegalView Supports Changes in FDA Medical Device Approval Process

Jan. 25, 2012 - PRLog -- LegalView, a leading online legal website, supports the revamp of the United States Food and Drug Administration's medical device approval process, as an update would better serve the consumers the FDA aims to protect.  

Currently, the U.S. FDA clears newly developed medical devices through its 501(k) application process. However, concerns over how this program approved medical devices such as [link=http://vaginalmesh.legalview.com/]vaginal mesh[/link], a medical device that has been linked to several serious complications, and other medical products as prompted many to see this outdated procedure changed.

Under this clearance process, newly manufactured medical devices can be cleared for use with little or no clinical testing if manufacturers can show that their device is substantially similar to those like it already on the market. This is known as a predicate device, and according to a Bloomberg, the FDA uses this system to review nearly 90 percent of all new medical devices.

While this system allows medical device manufacturers to avoid the time and expense of clinical testing and gets devices to patients sooner, it has some safety flaws. The system is designed to allow new devices' safety and effectiveness to be tied to their predicates which have already been cleared by the FDA, but if those predicates are voluntarily pulled off the market or are shown to be defective, the new medical device can still stay on the market.

Many consumer advocates would like to see this process updated because vaginal mesh was cleared using this program, and the device is now tied with almost 650 personal injury lawsuits around the country.

In 1996, vaginal mesh designers, Boston Scientific produced a mesh called ProteGen Mesh and it was cleared by the FDA. Subsequently, the device was listed as a predicate for the Johnson & Johnson vaginal mesh, Gynecare TVT, which was approved through the 501(k) process.

However, within a year of its approval for patient use, ProteGen was pulled off the market after the FDA received over 120 reports that it was causing complications such as discomfort, vaginal tissue erosion, and painful intercourse. However, Johnson & Johnson's Gynecare TVT stayed on the market and was used as other predicates in other 501(k) approval applications, even though the original device had shown to cause injury to patients.

The FDA's 501(k) application process was also used to approve Johnson & Johnson's DePuy hip implants which has been linked to many personal injury lawsuits and a [link=http://depuyrecall.legalview.com/]depuy hip recall[/link].

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