Thousands of Australian women suffering "devastating complications" from transvaginal mesh implants have been "ignored" and "let down" by health professionals and regulatory bodies, and the surgery should only be performed as a "last resort", a Senate inquiry into the devices has concluded.
“The committee is deeply concerned by the accounts it has received of women’s experiences at the hands of medical practitioners,” the inquiry, which has been running since July last year, reported on Wednesday night.
“Even allowing for the positive accounts provided to the committee and the fact that some accounts are recalling events of over 10 or 15 years ago, they present the medical profession in a very poor light.”
Surgeons must obtain “informed consent” from patients receiving transvaginal mesh implants and medical regulators must record adverse side effects properly, the inquiry wrote in its 13 recommendations.
Urogynaecological meshes, sometimes known as transvaginal meshes, are inserted into women as a treatment option for pelvic organ prolapse (when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth), or urinary incontinence.
The inquiry estimated about 150,000 women in Australia have undergone transvaginal mesh procedures.
The underreporting of adverse events associated with transvaginal mesh products had provided a “false indication of the safety” of the devices, the report said.
There were more than 150 patient submissions made to the inquiry, the most heartbreaking of which you can read here, and almost all of them claimed there was no informed consent or awareness of the possible complications.
Almost every submission details a complication after the mesh was inserted.
These include: chronic and constant vaginal pain, visceral pain with bowel movements, dyspareunia (pain during sex), vaginal bleeding, inability to sit for more than an hour at a time, the granulation of vaginal tissue, pain through the glutes, inflammatory reactions, "offensive discharge", incontinence, leg weakness, and haemorrhages.
Dozens of women described "erosions" — when the product enters surrounding tissue, protrudes out of a body structure or tissue and into surrounding organs, causing holes or even haemorrhaging.
One woman had more than 12 operations to treat erosions and attempt to remove parts of her implant that were threatening to puncture surrounding organs.
“Many women who have had transvaginal mesh implants have had devastating complications resulting in ongoing emotional trauma, embarrassment, shame, depression, debilitating pain, recurring infection and a poor quality of life," the report said.
“The inquiry heard from many women who are living with the consequences of having had these implants. It is heartbreaking that for so long the experiences of these women have been ignored. These women have been let down, the system has failed them."
Women who couldn't have vaginal sex due to ongoing sexual dysfunction from urogynaecological mesh "repeatedly" reported their doctors suggested having anal sex instead, the Senate inquiry heard in August.
Half of the women who experienced adverse physical and psychological side effects after receiving a vaginal mesh implant have also suffered from a relationship breakdown after the procedure, the inquiry also heard.
The committee heard from doctors, hospitals and device manufacturers, including Johnson & Johnson, which in January withdrew from the market the controversial devices at the centre of a class action against it.
After nine months of consultations and hundreds of submissions the inquiry released the following 13 recommendations:
1. The Australian government, in consultation with the states and territories and the Medical Board of Australia, should review the current system of reporting adverse events to the Therapeutic Goods Administration (TGA) to implement mandatory reporting of adverse events by medical practitioners.
2. The TGA should develop a fact sheet for recipients of the devices to provide guidance on what to do (where to be treated and how to report it) in the event of an adverse event.
3. The Australian government should consider establishing a registry for all high-risk implantable devices.
4. The Medicare Benefits Schedule should release the report of the Gynaecology Clinical Committee (which recommended restricting the use of mesh to patients who are undergoing revision surgery) for consultation. Revision surgery refers to when a patient needs to have another operation to try to address the adverse impacts of the initial mesh insertion.
5. The Australian government should establish a better post-market monitoring scheme.
6. The Australian Commission on Safety and Quality in Health Care (ACSQHC) should prepare material on "informed consent" processes which would clarify the rationale for the proposed treatment and discuss potential complications as well as risks and benefits.
7. Treatment guidelines should clearly indicate that transvaginal mesh implantation should only be undertaken with fully informed consent and as a "last resort".
8. Medical professional specialist colleges and societies should make sure their members have access to resources on this topic.
9. Federal and state health ministers should require that guidance developed by the ACSQHC for the credentialing of medics who perform transvaginal mesh procedures should underpin credentialing in all public hospitals.
10. Medical professional colleges should implement arrangements for transvaginal mesh procedures which require their members are trained in the use of the device and are adequately skilled to perform the specific procedure.
11. State and territory governments should commission the ACSQHC to audit transvaginal mesh procedures undertaken and their outcomes.
12. The implant manufacturing industry and medical profession should work together to support high ethical standards.
13. State and territory governments should continue to work with ACSQHC to review the provision of services for the use and removal of transvaginal mesh devices and install a hotline and counseling programs.