A patient experienced complete resorption of veritas which caused a seroma, after undergoing a surgery in which veritas was used.The resorption was further described as ¿bottoming out of the implant¿ which required revision surgery.The patient had undergone breast reconstruction surgery.The implants were placed partially under the pectoralis major muscle with veritas used to cover the lower pole of the implant and sutured to the pectoralis major muscle superiorly to hold the detached end of the muscle in position and to the chest wall inferiorly and laterally.Subsequently, on return to the surgical theatre for the expander removal and insertion of the final implant, the surgeon noted that there was no veritas and/or no integration of lower pole, the veritas collagen matrix was dissolved leaving only a yellow, gel-like seroma in the implant cavity.This required the patient to undergo revision surgery (date unspecified).No further detail was provided regarding the patient¿s outcome from the event.No additional information is available.
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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