Case 10 Irregular intermenstrual bleeding in a woman on the pill
Joanna, a 29-year-old housewife, presented to Dr Hanson with a four-month history of intermenstrual bleeding. A year before she had had a normal vaginal delivery of her first baby. Six months ago, when she stopped breast feeding, Joanna changed from the progesterone only pill to the combined contraceptive pill (COCP). Initially she had no problems but for the past four months she had experienced occasional spotting towards the end of the packet.
What would you do?
Joanna had had a normal smear two years ago. Dr Hanson told her that it was common to get breakthrough bleeding on the pill and that it was just a matter of finding a pill that suited. Joanna was given three packets of a different COCP.
She returned a year later to see Dr Bennett. She had had lower abdominal pain and dysuria. She had not continued with the pill because she and her husband wanted to try for another baby. After stopping the COCP her periods had been irregular. She had continued to have intermenstrual and postcoital bleeding but had thought that this was normal after stopping the pill. On examination Joanna did not have a raised temperature. Her lower abdomen was slightly tender. The Dr Bennett did not perform a vaginal examination because Joanna had her period. An MSU was requested and Joanna was given trimethoprim for a presumed urinary tract infection. Dr Bennett informed Joanna that they would let her know if she needed a different antibiotic and also that she should return if she continued to have intermenstrual bleeding.
Would you have done anything differently?
Two months later Joanna returned with continuing symptoms and saw a different partner. Dr Lynch was unable to see the cervix and in view of her persisting symptoms referred Joanna non-urgently to the gynaecologists. Two days later Joanna went to A&E following a heavy postcoital bleed. On examination she was found to have a cervical carcinoma.
Joanna sued the general practitioners on the premise that she should have been examined when she first presented with abnormal vaginal bleeding and that this would have resulted in an earlier diagnosis and treatment on the cervical cancer.
Expert opinion
Cervical cancer is very rare in primary care. The incidence of cervical cancer in the UK fell by 42% between 1988 and 1997 (Peto et al., 2004; Quinn et al., 1999).
A significant problem in general practice is that cancers are rare but symptoms that may signify cancer are very common (Summerton, 2002). Abnormal vaginal bleeding is extremely common in primary care. In one practice in the UK (with 10 000 patients) all women aged 18–54 were sent questionnaires on menstrual problems. In the previous 12 months 25% had experienced menorrhagia, 17% had experienced IMB and 6% PCB (Shapley et al., 2004). It is also recognized that unscheduled bleeding is common during the first three month of using hormonal contraception.
When Joanna first presented it was unlikely that she had cervical cancer. However she had had IMB for four months. The Faculty of Sexual and Reproductive Health recommends that if a woman has unscheduled bleeding on hormonal contraception:
- A clinical history should be taken to determine if there are any associated symptoms and exclude the possibility of a sexually transmitted infection.
- The cervical screening history should be ascertained.
- A pregnancy test should be considered.
If the IMB has been for less than three months and there are no features to suggest a cause other than spotting associated with the hormonal contraception no further examination or investigation is required. If however, as in this case, the unscheduled bleeding has been for more than three months a speculum examination should be performed to inspect the cervix (Clinical Effectiveness Unit, 2009). If the cervix had been inspected and was normal it was necessary to ask the patient to return in the middle of the last pill packet in order to check that the IMB had stopped and to prescribe the next supply.
Of menstrual abnormalities (IMB, PCB, menorrhagia) post-coital bleeding (PCB) is the symptom that is probably considered to have the highest likelihood of cervical cancer. One review states: ‘Post coital bleeding is regarded as the cardinal symptom of cervical cancer’ (Shapley et al., 2006).
A well-constructed systematic review in the British Journal of General Practice, June 2006, examined the likelihood that a woman presenting with post-coital bleeding (PCB) would have cervical cancer (the PPV of the symptom). In the age range 25–34 the chance that a woman presenting with PCB has cervical cancer is estimated at 1 in 5600 (6). This compares with the likelihood that someone aged over 45 with rectal bleeding has colorectal cancer which is likely to be around 5% (Shapley et al., 2006).
There is various and slightly conflicting guidance on indications for specialist referral for women with menstrual bleeding disorders. For PCB referral is variously suggested for ‘repeated’ (NHS Executive, 2000), ‘persistent’ (Rosenthal et al., 2001) or ‘persistent for more than 4 weeks in women over 35’ (NHS Executive, 2000). NICE guidance suggests considering urgent referral for women with persistent IMB and a normal pelvic examination (NICE, 2005). This is particularly the case in women aged over 45 years and, if IMB continues for longer than three months after starting hormonal contraception or there is a change in bleeding pattern in women under 45 years in the presence of risk factors for endometrial carcinoma such as obesity, polycystic ovaries and diabetes.
The place of cervical smears in the investigation of someone with a previously normal cervical smear that has menstrual symptoms is also contentious. A 1997 paper in the British Journal of General Practice made the point that a normal cervical smears does not exclude cervical cancer (because there is a 10% false negative rate) and that IMB and PCB are not indicators for a repeat cervical smear (in someone who has previously had a normal smear). ‘An additional cervical smear in these circumstances contributes little or nothing to the diagnostic process’ (Woodman et al., 1997).
What is clear is that, because cervical smear has a sensitivity of only 80% to 90% for cervical cancer it is not a ‘SnOUT’.
The June 2005 NICE guidance advised that abnormal vaginal bleeding should prompt a full pelvic examination with visualization of the cervix. An abnormality of the cervix should prompt referral independent of cervical smear status.
When Joanna presented for the second time Dr Bennett failed to make a full clinical assessment. He/she prematurely anchored on a diagnosis of cystitis and did not consider a differential diagnosis. At this stage it was necessary to: take a good history of the normal pattern of vaginal bleeding, the change in vaginal bleeding, the duration of the change and any co-existent lower genital tract symptoms (such as vaginal discharge, pain on intercourse, PCB); take a history of all drugs that may affect menstrual pattern, particularly the oral contraceptive pill; carry out a pelvic examination, assess the size of the uterus, any adnexal masses, pelvic tenderness and inspect the cervix using a vaginal speculum; take triple swabs. If Joanna had not wanted to be examined because it was her period an appointment should have been made for the following week. At this examination an abnormal cervix would have been seen and an urgent two-week referral made.
Legal comment
Joanna could name Dr Hanson and Dr Bennett as Defendants in her claim. But she may well decide instead to name the GP practice as a whole.
In principle, a GP partnership (i.e. each individual partner) is liable for the actions not only of their staff but also of each other individual partner. It would usually be a requirement that each medical partner and member of staff has his or her own MDO cover, so that the partnership’s liability is met in this way. If for some reason either Dr Hanson or Dr Bennett does not have MDO cover, then the partnership will have to compensate Joanna, and try to then recover the money from the negligent partner (who may or may not have the resources to pay).
In this case, expert opinion suggests that although Dr Hanson may have been negligent (he should have told Joanna to return if the symptoms did not resolve), he may also have a causation defence, i.e. that even if he were negligent, no damage was caused because it is probable that there was no cervical cancer at that time.
Dr Bennett, on the other hand, is in a different position. He should have arranged to do a vaginal examination when he would have made findings leading to an urgent referral. Two months would have been saved.
Would those two months have made a difference to Joanna? That question requires its own expert opinion. If the answer is little or none, then Joanna’s compensation will be limited to the extra pain and suffering and distress she has experienced: a few thousand pounds. If it means the difference between life and death, or the loss of her fertility, then this could be a substantial claim.