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Critics Slam FDA 510(k) Clearance Process on Medical Devices as Idiotic by Janet Price

Critics Slam FDA 510(k) Clearance Process on Medical Devices as Idiotic by
Article Posted: 04/19/2013
Article Views: 65
Articles Written: 7
Word Count: 551
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Critics Slam FDA 510(k) Clearance Process on Medical Devices as Idiotic

The 510(k) clearance process of the Food and Drug Administration (FDA) came under fire again. This time consumer organizations across the United States called it idiotic, blaming the federal agency for tolerating the practice of medical device makers to use their patrons -- men and men who buy their products -- as human guinea pigs in research and development. For most of them, it defies logic how a supposedly responsible agency might allow a product to be sold when it has been admitted to be similar to one that the FDA itself considers as unsafe and ineffective. The FDA on August 12, 1996 granted clearance to Boston Scientific to sell a new vaginal mesh device intended to treat urinary incontinence in women using the agency’s 510(k) notification process. With the Mersilene Mesh as the predicate, a device used for treating hernia, ProteGene Sling was then made available to the market immediately thereafter. After being in the market for only 26 months, Boston Scientific submitted a letter to the FDA on January 1999 informing the agency of their intention to recall the ProteGene Sling which was subsequently approved by the agency. In its enforcement report issued on March 1999, the FDA stated that the use of ProteGene in the repair of urinary incontinence is associated with a higher-than-expected rate of vaginal erosion and further asserted that said product did not appear to function as intended.

Even before ProteGene was withdrawn from the market, already three products were being sold using the ProteGene Sling as a predicate device. Influence, Inc. was able to get clearance for their In-Sling in September 1997 and the TriAngle in March 1998. The Tension Free Transvaginal Taping (TVT) devise of Ethicon, a division of Johnson & Johnson, was also cleared on October 1997. In April 30, 1998, the FDA also gave clearance to Mentor Corporation to market its Mentor Suspend sling.

While the granting of the clearances for the three companies to distribute their vaginal devices using the ProteGene Sling as predicate device may be reasonable, what may be considered perplexing were the approvals of other mesh devices using the recalled ProteGene as a predicate. Over 50 such devices from various companies have been cleared since then using this recalled device as a direct or indirect predicate. Included among these were the Prolift of Ethicon and Avaulta of Bard, both of which were the subjects of litigations that were recently resolved in favor of the plaintiffs.

Even in their own report, they have determined that these devices have been responsible for the numerous adverse reports they have received. Yet, no actions have been directly taken by the agency even in the face of thousands of product liability lawsuits filed by women injured by these devices. To make matters worse, in their latest announcement made on March this year, they seem to encourage the continued use of these deadly devices.

About the Author

The author was really taken aback upon learning of the events leading to the approval of the various vaginal mesh devices. Many agree that the FDA should also be held responsible for the pain and suffering experienced by thousands women as a result of these devices which has led to vaginal mesh lawsuits across the country. Learn more about this by visiting

Related Articles - vaginal mesh, health, news, women, implants,

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