Pelvic mesh problems need register now
The Consumers Health Forum welcomes the tighter regulation of pelvic mesh implants and calls for the introduction of a mandatory register to record problems with implants so that action is initiated at the earliest opportunity to reduce risk of harm to other patients.
The Therapeutic Goods Administration has today announced the de-registering of a number of mesh products whose sole use is the treatment of pelvic organ prolapse by means of transvaginal implantation. The ban follows a review of the latest international studies and the clinical evidence about products supplied in Australia.
“The TGA says the overall benefits of using these products for treatment of pelvic organ prolapse do not outweigh the risks that these products pose to patients,” the CEO of the Consumers Health Forum, Leanne Wells, said.
“Problems with these mesh implants, particularly in treating prolapse, go back several years. While most patients have benefited particularly when it is for the more commonly treated condition of incontinence, the hundreds of women who have suffered severely as a result of this implant over the years clearly suggests we need a more vigorous and rigorous response.
“The complex scope of the issue is highlighted when it is considered that since 2013 the TGA has removed 45 pelvic mesh devices from the Australian therapeutic goods register.
“The medical profession needs to take a more active role in alerting the TGA and their patients promptly when problems emerge.
“First do the patient no harm,” is the fundamental rule doctors should follow. This rule surely should apply most importantly when they are implanting devices in their patients.
“A reporting system by means of a register under which adverse events involving implants are required to be reported promptly would go a long way in identifying potential pitfalls,” Ms Wells said.