On 28 November 2017, the Therapeutics Goods Administration (TGA)removed transvaginal mesh products whose sole use was for the treatment of Pelvic Organ Prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods (ARTG).
This decision was based on a review of the latest published international studies and an examination of the clinical evidence for each product included in the ARTG and supplied in Australia.
Based on this information and since the publication by the TGA of the Results of review into urogynaecological surgical mesh implants, the TGA believes that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients.
However pending further investigation, Pelvic Organ Prolapse mesh can still be implanted via the abdominal route despite the fact many women have had serious adverse events when the abdominal route has been used.
What is Pelvic Organ Prolapse ?
Pelvic organ prolapse (POP) occurs when tissue and muscles can no longer support the pelvic organs and they drop down.
What are the different types of Pelvic Organ Prolapse ?
There are several types of prolapse that have different names depending on the part of the body that has dropped.
Cystocele. The bladder drops into the vagina.
Enterocele. The small intestine bulges into the vagina.
Rectocele. The rectum bulges into the vagina.
Uterine Prolapse. The uterus drops into the vagina.
Vaginal Vault Prolapse. The top of the vagina loses its support and drops.
What are the symptoms of Pelvic Organ Prolapse ?
Symptoms of POP can come on gradually and may not be noticed at first. A health care professional may discover a prolapse during a physical exam. Women with symptoms experience the following:
Feeling of pelvic pressure or fullness
Bulge in the vagina
Organs bulging out of the vagina
Leakage of urine (urinary incontinence)
Difficulty completely emptying the bladder
Problems having a bowel movement
Lower back pain
Problems with inserting tampons or applicators
How is Pelvic Organ Prolapse treated ?
If you have POP symptoms, and they interfere with your normal activities, you may need treatment. Nonsurgical treatment options should always be tried first. If these options do not work and if your symptoms are severe, you may want to consider surgery but only as a last resort.
What are the nonsurgical treatments for Pelvic Organ Prolapse ?
You may be able to improve some symptoms without surgery with lifestyle changes, pelvic floor exercises, pessaries, and topical estrogen cream. These treatment options are safe, and either alone, or in combination, may give you good results.
Reducing weight, avoiding heavy lifting, avoiding constipation and chronic coughing, stopping smoking and doing low impact exercises. These options can help lessen your awareness of your prolapse and contribute to overall good health.
Watch and see
The good news is that POP is not dangerous to your health! If you do not have discomfort, monitoring the POP over time is an option as it may stay the same size or it may worsen over the years.
Pelvic Floor Exercises
Pelvic Floor exercises are intended to strengthen the pelvic floor, over time, through actively tightening and lifting the muscles at regular intervals. It is important to involve a health professional specialising in the pelvic floor, such as a physiotherapist with a special interest with a special interest in pelvic floor dysfunction or a continence nurse to give instruction and ensure you are doing them correctly which will assist in improving the outcomes of these exercises.
These exercises can reduce your symptoms or the need for surgery. They need to be done correctly and consistently over time as they are not a quick fix.
If you’re unable to contract your pelvic floor muscles, using a device that measures and stimulates the electrical signals in the muscles may be recommended. This is called electrical stimulation. A small probe will be inserted into the vagina in women or the anus in men. An electrical current runs through the probe, which helps strengthen your pelvic floor muscles while you exercise them. You may find electrical stimulation difficult or unpleasant to use, but it may be beneficial if you’re unable to complete pelvic floor muscle contractions without it.
Information about pelvic floor exercises, continence nurses and physiotherapists with a special interest in pelvic floor dysfunction is available from the Australian Physiotherapy Association.
WWW.physiotherapy.asn.au/APAWCM/ Physio_and_You/Pelvic_Floor.aspx or the National Continence Helpline on 1800 33 00 66 or the Continence Foundation of Australia at: www.continence.org.au/ pages/pelvic-floor-women.html
Biofeedback is a way to monitor how well you’re doing the pelvic floor exercises by giving you feedback as you do them.
There are several different methods of biofeedback:
- a small probe could be inserted into the vagina in women – this senses when the muscles are squeezed and sends the information to a computer screen
- electrodes could be attached to the skin of your tummy (abdomen) or around the anus – these also sense when the muscles are squeezed and send the information to a computer screen
Speak to your specialist if you would like to try biofeedback.
Your GP can refer to a specialist physiotherapist who specialises in pelvic floor dysfunction.
A vaginal pessary is a device that’s placed in the vagina to support the pelvic floor and support the prolapsed organ. They are made from vinyl, silicone or latex. Your doctor or specialist physiotherapist who has an interest in pelvic floor dysfunction will fit and insert the pessary. They are safe to use both short and long term and there may be improvement in prolapse symptoms and bladder, bowel and sexual function. You may need an internal examination and try a few types to find what works for you.
Oestrogen cream can be applied to reduce vaginal dryness and improve tissue quality of a prolapsed vaginal wall. Where urinary infection has been a factor, this may be helpful.
Types of Native Tissue Repair Surgery for POP
This type of procedure involves reinforcing your damaged tissue by attaching them to your ligaments, with a graft of tissue from another part of your body (such as the lower abdomen) or with stitches. There are several types of native tissue repair operations, depending on the position of the prolapse. These include:
Uterosacral or Sacrospinous Ligament Suspension
This procedure is used to restore the support of the top of the vagina also known as Apical Suspension. If you have a uterus, this surgery can be done at the same time as a hysterectomy. If you have already had a hysterectomy, this surgery supports the top of the vagina. Sexual function is possible after this surgery. It is performed through the vagina with no abdominal incisions and no mesh. Your surgeon stitches the top of the vagina to a ligament in the pelvis.
Anterior Vaginal Prolapse Repair (Anterior Repair)
Anterior repair uses an incision in the wall of the vagina underneath the bladder to fix a cystocele. Sutures are used for the repair and sometimes a graft of tissue from another part of your body.
Posterior Vaginal Prolapse Repair (Posterior Repair)
Posterior repair uses an incision in the wall of the vagina over the rectum to fix a rectocele. It rebuilds the wall between the vagina and the rectum. Sometimes a graft of tissue from another part of your body will be used too.
Lefort Colpocleisis, Total Colpocleisis
Total colpocleisis is an operation reserved for women who no longer wish to be sexually active. The vagina is shortened by sewing the vaginal walls together. This is low risk with a high success rate.