Women's vaginas mutilated by transvaginal mesh complications and revision surgeries
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Australian pelvic mesh injured women are in a serious crisis. With the information and evidence we have gathered, we believe that the Minister for Health has an obligation to act on this immediately.
Complications from these implants are destroying women's lives by causing permanent damage to their pelvic and leg regions.
The TGA lists the following complications
punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel (these may require surgical repair)
transitory local irritation at the wound site
a 'foreign body response' (wound breakdown, extrusion, erosion, exposure, fistula formation and/or inflammation)
mesh extrusion, exposure, or erosion into the vagina or other structures or organs
as with all foreign bodies, mesh may potentiate an existing infection
over-correction (too much tension applied to the tape) may cause temporary or permanent lower urinary tract obstruction
acute and/or chronic pain
pain during intercourse
neuromuscular problems including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area
recurrence of incontinence
bleeding including haemorrhage, or haematoma
atypical vaginal discharge
exposed mesh may cause pain or discomfort to the patient’s partner during intercourse
swelling around the wound site
excessive contraction or shrinkage of the tissue surrounding the mesh
vaginal scarring, tightening and/or shortening
granulation tissue formation.
The Australian Pelvic Mesh Support Group request a senate inquiry into the following governing organisations:
1. The Therapeutic Goods Administration
a) We believe that the TGA is failing to meet its own guidelines, thereby putting the health and safety of women at risk of permanent injury and debilitating lifelong pain and suffering caused by permanent pelvic mesh implants which are used for prolapse and stress urinary incontinence.
b) We want to know why there is no mandatory reporting by doctors and specialists when a woman presents with pelvic mesh complications? The TGA rely on the adverse events database for statistics and this database is highly underreported, therefore it can not be relied on. Women injured by pelvic mesh suffer severe anxiety, pain and post traumatic stress; reporting their adverse events is not something they consider nor do they know that they have this option available to them. This database is the only evidence the TGA use to track complications. There are only 99 reported incidents yet there are 600 injured women in class actions against manufacturers of the devices.
a) We would like the Minister for health to request evidence from RANZCOG where they state that partial removal is appropriate management of complications.
b) To investigate why RANZCOG are doing nothing to bring international surgeons to Australia to train on full removal of implants. RANZCOG state "Complete removal of mesh is an extremely challenging procedure associated with not insignificant patient morbidity. There is increasing evidence that partial removal of mesh is the appropriate management of infection, vaginal or visceral exposure or pain".
We the mesh injured disagree entirely with this statement. 12 women from Australia have chosen to travel at their own expense to the USA for full removal of their prolapse and SUI meshes because RANZCOG will not train surgeons here in full removal. The women who have had full removal in the USA continue to suffer pain and ongoing complications however, they are relieved to have the mesh out and would rather live in pain without mesh than live in pain with mesh.
Why then are these implants allowed to continue when no surgeon in Australia can fully remove it? This is unethical.
c) Why is there a committee member in RANZCOG who "has contracts as a preceptor for Johnson & Johnson Gynecare as well as American Medical Systems mesh products for which he/she receives a fee. He/she has received financial support from both organisations to attend scientific conferences as an invited lecturer"?
3. PLAC - (Prostheses List Advisory Committee)
PLAC funds pelvic mesh devices.
Why are there two committee members who have a clear conflict of interest and
1. "holds contracts as a preceptor for Johnson & Johnson Gynecare as well as American Medical Systems mesh products for which he/she receives a fee. He/she has received financial support from both organisations to attend scientific conferences as an invited lecturer."
2. "has acted as preceptor for American Medical Systems and Johnson and Johnson and is in receipt of a sponsorship for an investigator-initiated randomised controlled trial for American Medical Systems. He/she has received sponsorships for clinical workshops from American Medical Systems and Johnson and Johnson."
There are three states in the USA who are suing Johnson and Johnson for deceiving surgeons and medical governing bodies about the complications of mesh. Why then are these implants still allowed to be used in women when there is a clear and obvious problem with these devices that is ruining women's lives?
Why has the Australian government not acted on behalf of mesh injured women after their meeting in Canberra with the TGA when we requested that all transvaginal mesh devices be suspended immediately until a thorough investigation is carried out? We have made it clear that the DAEN database is underreported and the figures are completely inaccurate. We asked the TGA and the TGA said NO.
URGENT CALL TO ACTION - There are over 200 women in the support group who are suffering and we need answers and we need help now. We need renowned international mesh removal surgeons to come to Australia immediately to remove our mesh devices. If our surgeons refuse to learn how to remove our implants, we need them removed by the overseas experienced surgeons, we need them to come to Australia. We have a right to be treated with dignity, respect and the utmost care. We are not receiving this care here in Australia. We have been suffering for years in silence. Minister for Health and Minister for Women, please help us, we have written to you many times and we feel our voices are falling on deaf ears.
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