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At the time, the announcement prompted several manufacturers to pull mesh products from the US market because they could not show the FDA's safety and effectiveness standards had been met."The redesignation of surgical mesh by the FDA to a higher risk category does not otherwise effect [sic] products approved in the past or those that are currently on the market, nor does it impose any further requirements on manufacturers clinicians to use these devices in any different way to that previously required," Jessamine said in the email."The key issue is communication with the patient to explain the surgical procedure, what is proposed to be used in that procedure and what are the risks and benefits of use of one particalr [sic] surgical approach or material against another," he continued."This requirement for disclosure and communications has always been in place and the FDA redesignation does not change or increase it."Another email from Jessamine referring to research commissioned by the executive arm of the European Union also demonstrated the selective approach Med Safe had when considering and endorsing information on surgical mesh.

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