China Announces Ban on Polyacrylamide Hydrogel Breast Implants

Citing a significant number of adverse events associated with polyacrylamide hydrogel breast implants, the Chinese State Food and Drug Administration (SFDA) has banned the production, sale, and use of the compound.

Polyacrylamide hydrogel is also widely used in other types of parenchyma implants used in orthopedic procedures for hips and cheeks.

From 2002 through November 2005, the SFDA claims to have received 183 reports of adverse effects from the use of polyacrylamide hydrogel implants. Of those, 161 involved breast-implant patients who suffered infections, deformation, and hardening.

As a result of the reports, the SFDA has taken the position that it can no longer vouch for the safety of implants using the substance and thus, the compound will no longer be certified and registered as an approved material.

Polyacrylamide hydrogel will no longer be permitted to be manufactured, sold, or used in China and all existing supplies of the substance and products containing it are to be recalled and destroyed under SFDA supervision. Any failure to comply with the SFDA mandate will result in criminal prosecution according to a government spokesperson.

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