Medical device manufacturer, Johnson & Johnson, has issued a medical device safety alert concerning its GYNECARE INTERCEED 3INX4IN [Product Code: M4350, Lot: All Lot numbers, GTIN: 10705031062740]
According to the manufacturer, a multi-centre, randomised clinical study recently conducted to evaluate the effect of INTERCEED in preventing abdominal adhesions in patients with colorectal carcinoma undergoing two-phase laparoscopic hand-assisted colorectal resection has shown that the incidence of adhesions at the target incision site were similar between the INTERCEED group and the Control group. There was no new safety issues identified. The study was terminated due to the lack of expected superior efficacy for INTERCEED.
The manufacturer recommends that health care practitioners should consider these study results in determining treatment during abdominal or gynaecological procedures. Patients who have been treated should be followed up post-operatively in the usual manner with no additional action required.
According to the local supplier, the products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 5 May 2021