An important step has been taken by the Royal College of Obstetricians and Gynaecologists (‘RCOG’) to ensure that all healthcare professionals considering the use of a morcellator for patients undergoing a hysterectomy (an operation to remove the uterus and in some cases the cervix) or a myomectomy (an operation to remove fibroids from the uterus), provide women with details of the risks involved in morcellation, in order to obtain their informed consent, to use this surgical instrument, before surgery.
The consent advice and information for patients was published this month and has been developed in collaboration with the Royal College of Radiologists, Royal College of Pathologists, British Sarcoma Group, Sarcoma UK and the British Society for Gynaecological Endoscopy, following the establishment of a Morcellation Task and Finish Group by the RCOG in February 2019.
Morcellators are used in order to cut up tissue, such as a uterus or fibroid, into smaller pieces so that they can be removed more easily.
Morcellation allows for these operations to be carried out laparoscopically (key hole surgery) or vaginally which reduces the length of the recovery period when compared to open abdominal surgery. There is also a reduced risk or infection and less pain after surgery when morcellators are used.
Whilst there are benefits to using a morcellator, the new guidance says patients must now be advised of the risks of morcellation. A serious risk which healthcare professionals must discuss with their patients is that when uterine tissue or a fibroid contain undiagnosed or unexpected cancer (uterine sarcoma) and are cut into small pieces, cancerous cells can be dispersed through the body including the blood supply and spread during surgery. In cases in which this occurs, the consequences can be devastating. Tumour cells can spread to sites such as the liver, lungs and lymph nodes resulting in metastatic cancer. In these instances the diagnosis is often terminal and the prognosis can be poor.
In respect of the law, the case of Montgomery –v- Lanarkshire Health Board  2 WLR 768 confirms that health professionals have a duty to take reasonable care to ensure that patients are aware of ‘material risks’. Health professionals must disclose any risk to which a reasonable person in the patient’s position would attach significance. If a healthcare professional fails to warn of such a risk then they are negligent.
In a very sad case, I acted for a lady who was diagnosed with a rare terminal gynaecological cancer in early 2015. In February 2008, my client had undergone a hysterectomy in which a morcellator was used, following the detection of a mass in her uterus which was thought to be a fibroid, but had not been properly investigated. The client had not consented to the morcellation and had not been advised of the risks of this procedure. The evidence that I obtained confirmed that the mass was a tumour and that during morcellation, cancerous cells had spread around the body. My client was diagnosed with metastatic cancer. As a result of this, my client’s prognosis was terminal and incurable. Liability was denied by the Defendant but a settlement was reached before trial.
Women who require a hysterectomy or myomectomy must now be provided with advice by healthcare professionals on what morcellation is, the risks and benefits of morcellation, what might affect the risk of having uterine sarcoma and the alternatives to morcellation.
This guidance and advice is long-awaited and is extremely important. It reminds healthcare professionals of their obligation to obtain prior informed consent from their patients. It is essential that discussion is encouraged between healthcare professionals and patients so that women are fully aware of the risks of each type of procedure and can then make an informed choice about which surgery or procedure is right for them.
Given that this guidance was only published this month, there will be many women who have undergone morcellation without prior informed consent of the risks of this procedure. This is a terrible situation and these women have been let down by healthcare professionals.
The Royal Marsden Hospital is a centre for excellence for cancer diagnosis and treatment. I would advise any women who are concerned to seek advice and treatment at this hospital.