Physiomesh Market Withdrawal
Ethicon Physiomesh Flexible Composite Mesh was brought to market in 2010, after receiving regulatory clearance via the U.S. Food & Drug Administration's (FDA) 510K program. This process does not require a device manufacturer to conduct human clinical trials, as long as it can be demonstrated that the new product is substantially equivalent to another device that was previously approved by the FDA\
On May 25, 2016, Ethicon announced a worldwide market withdrawal of Physiomesh Flexible Composite Mesh, due to the higher recurrence and revision rates seen in the unpublished European data. Ethicon was unable to determine the cause of this issue, but noted that it could be due to product characteristics, as well as operative and patient factors. The company indicated that it had informed the FDA of the action, and said that it would not be returning the affected Physiomesh product to the worldwide market.
Individuals who experienced recurrence and revision following laparoscopic ventral hernia repair with Ethicon Physiomesh Flexible Composite Mesh may be entitled to compensation for medical bills, lost wages, pain and suffering and more. To learn more about filing an Ethicon Physiomesh lawsuit, please visit Bernstein Liebhard LLP's website, or call 800-511-5092 to arrange for a free, no obligation case review.
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Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal's "Plaintiffs' Hot List," recognizing the top plaintiffs firms in the country. This year's nomination marks the thirteenth year the firm has been named to this prestigious annual list.
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