J&J Gynemesh Prolene
Mesh Medical Device News Desk, September 18, 2017 ~ A Senate inquiry continues in Australia today and Tuesday as Johnson & Johnson and Boston Scientific present evidence on the safety and efficacy of the pelvic mesh devices.
Meanwhile two meshes have been removed from the Australian market.
Joanne McCarthy a reporter for Australia’s The Herald newspaper, writes Johnson & Johnson (J&J) has withdrawn two of its controversial pelvic meshes from the Australian market after feds asked for more evidence of device safety.
Instead of a quiet recall from the market, J&J told a Senate pelvic mesh inquiry in that country that it had “decomercialized” the Gynemesh Prolene and Gynemesh PSXL. The meshes are made of polypropylene and are a bridging material for apical vaginal and uterine prolapse.
J&J Submission Report, Read the rest here: file:///C:/Users/Jane/Downloads/JNJ%20Submission_Products%20Decommercialised.pdf
The instructions for use, the warning brochure within the package, had become cost costly to change.
Australia’s version of the U.S. Food and Drug Administration, the Therapeutic Goods Administration (TGA) required changes in the instruction brochure for the product.
“The costs of making a change only for the Australian market would exceed the total value of the sales of the product for 2016,” the company said in a statement. J&J denies this is a recall and says the company “continues to have confidence in the safety and efficacy of these products,” the article quotes J&J as saying.
There will be a public hearing Monday at the Parliament House in Sydney and another at the Canberra Parliament on Tuesday, all part of an inquiry by Victorian Senator Derryn Hinch.
Sen. Derryn Hinch, Au Senate
He has called the pelvic mesh debacle “one of the greatest medical scandals and abuses of mothers in Australia’s history.”
Johnson & Johnson and Boston Scientific will be present to give evidence on the Monday inquiry.
See Women Speak of Horror of Vaginal Mesh Implants story today here.
The devices were cancelled from the TGA registry August 22.
McCarthy reports in 2013 there were 100 different mesh devices manufactured by 42 companies on the TGA register. Last month there were just nine mesh device companies making 22 mesh devices.
There are more than 700 Australian women who are in the midst of a six month class action lawsuit being heard in a Sydney courtroom.
J&J is facing more than 55,500 pelvic mesh product liability lawsuits filed around the globe, according to its recent SEC report. ###
Johnson & Johnson Submission here.