Boston Scientific Corporation recalls any remaining unimplanted Pinnacle LITE Pelvic Floor Repair Kit, Posterior, and Xenform Soft Tissue Repair Matrix, with the indication for transvaginal placement of POP

Update - Boston Scientific mesh recall

17 May 2019

This advice supplements previous advice from the 22 December 2017 statement.

Background

In August 2017, supply of the Pinnacle LITE Pelvic Floor Repair Kit was discontinued from the Australian market.

In December 2017, the indications for use of the Xenform Soft Tissue Repair Matrix were amended to remove the indication for transvaginal placement of pelvic organ prolapse (POP). This device has other indications for use in the repair of soft tissue defects and thus remains on ARTG for these other uses.

Current action

A recall was issued by Boston Scientific Corporation Pty Ltd on 2 May 2019, RC-2019-RN-00681-1 to remove any remaining unimplanted product from the Australian market for:

• Pinnacle LITE Pelvic Floor Repair Kit, Posterior
• Xenform Soft Tissue Repair Matrix, with the indication for transvaginal placement of POP.

Table 3 in the December 2017 statement has been updated to include this action for Xenform. The ARTG for Pinnacle LITE Pelvic Floor Repair Kit, Posterior was cancelled by the sponsor and as such does not appear in the tables below.

Previous instances and previous reports (TGA)