The Urogynaecological Mesh scandal
7th Sep 2017
Approximately 50% of women who have had children will suffer some degree of pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI). Some women may suffer from both problems. It is most common in menopausal women who have had multiple pregnancies, difficult deliveries or bigger babies. The prolapsing organs can be the uterus, bowel and bladder.
Women suffering from POP can experience a sensation of something coming down or out of the vagina, a heavy dragging feeling, problems with passing urine such as stress incontinence, urinary tract infections, bowel-emptying problems and discomfort during sex.
Initially, a doctor may recommend conservative treatments such as pelvic floor exercises and the use of pessaries. Pelvic floor exercises may strengthen surrounding muscles and a vaginal pessary is a removable device placed into the vagina to support areas of POP. However, for a significant number of women these measures may be insufficient. Historically, the next step has typically been to consider surgery using mesh. The mesh is implanted into spaces/compartments in the pelvis and held in place by sutures or tissue fixation devices to points in the pelvic floor muscles and ligaments.
Given the number of women who suffer POP or urinary stress incontinence, it is immediately possible to see what an enormous potential and ongoing market exists for surgical mesh products. As a result a large number of different mesh products have found their way onto the market. They are either synthetic or porcine (pig-based product) devices.
The Australian Therapeutic Goods Administration (TGA) began monitoring surgical meshes in 2008 and published information for the public and health professionals. From 2010, the TGA monitored these products through its adverse event reporting system.
Between 2006 and 2012, the TGA received 63 adverse event reports for all urogynaecological surgical meshes. From July 2012 to 1 June 2016, the TGA received 99 adverse events reports. The most frequently reported adverse events were pain and erosion. It would be safe to say that the reported adverse events would in no way represent the true number of women who have experienced significant problems since having mesh implanted. The TGA encourages consumers and health professionals to report problems with medical devices, but doctors may not want to jeopardise their relationships with companies that manufacture the products and women may not be aware that they can self-report to the TGA.
In May 2017, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists made a submission to the Senate Community Affairs References Committee. It noted that between 2002 and 2015, 106,150 women had mid-urethral sling procedures. The mid-urethral sling procedure is performed to treat urinary incontinence and involves laparoscopic and per-vaginal surgery where mesh is inserted under the urethra for support. Of the 106,150 operations, 7.3% needed either sling revision or division.
The UroGynaecological Society of Australasia (UGSA) has compiled a voluntary database on urogynaecological procedures. It is acknowledged as being not particularly helpful as it predominantly contains data from sub-specialists. Urogynaecology is a subspecialty of gynaecology, but many gynaecologists believe that they are suitably qualified to perform mesh surgery. However, the database does tell us that from 1999, in Australia, approximately 120,000 women have had a mid-urethral sling procedure.
According to the UGSA submission, it was estimated in 2012 that 2.3 out of every 1,000 women underwent surgery for POP, but the percentage of these with mesh is unknown because surgery coding does not distinguish how the repair was done.
The Senate Inquiry also revealed that women unable to have vaginal sex after mesh surgery were being advised by their doctors to have anal sex instead.
The problems women can suffer can be serious and debilitating. The TGA lists 30 adverse events that may be associated with meshes. Most serious problems include punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel which may require surgical repair.
One patient, Ms Caz Chisolm, who has since set up the Australian Pelvic Mesh Support Group, says that many women were not told of the risks of mesh surgery, and did not give informed consent to the implantation of mesh.
There are currently class actions underway in Australia. The largest is the Ethicon class action commenced in July 2017 in the Australian Federal Court against Johnson & Johnson. However, it is evident that the problem extends beyond the current legal cases.
In my experience, clients suffering from complications associated with mesh may experience the trauma as similar to the aftermath of a sexual assault. Women go to see a gynaecologist with a personal, sensitive medical condition which may be having a detrimental effect on their relationship and sex-life. If the outcome of seeking treatment results in further trauma to their gynaecological organs it may be psychologically processed as sexual trauma inflicted upon them. For this reason, a thorough psychological or psychiatric assessment may be warranted.
The mesh problem is not going to go away any time soon. So many women have had mesh implanted and problems related to mesh can emerge over an extended period. However, we do know that the TGA knew mesh was a problem long before adequate action was taken to let the public know the risk it presents.
Ngaire Watson is a barrister at Sir Owen Dixon Chambers, Sydney. She is an ALA member and a member of the Precedent editorial committee. Ngaire is also a Registered Nurse and specialises in medical negligence litigation.