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The Dudley Group NHS Foundation Trust

P-001346 · Statement · Decision date: 8 March 2022 · View The Dudley Group NHS Foundation Trust scorecard
Complaint (AI summary)
Ms Z complained she developed a pulmonary embolism due to Depo-Provera injections provided by the Trust, leading to lifelong medication, distress, and worry about her health.
Outcome (AI summary)
Not upheld. The ombudsman found no indication that anything went wrong in how the Trust provided Ms Z’s Depo-Provera contraceptive injections.

Full decision details

The Complaint

3. Ms Z complains about the care and treatment she received from the Trust. She received a diagnosis of pulmonary embolism on 14 January 2019. She says a doctor told her Depo-Provera injections the Trust provided in 2018 caused this.

4. Ms Z says she must now take rivaroxaban (an anticoagulant used to prevent or treat harmful blood clots) for the rest of her life. She says she has experienced distress, and she is worried she may die.

5. In bringing this complaint to us, Ms Z would like compensation.

Background

6. Ms Z had Depo-Provera injections on:

· 5 April 2018 · 28 June 2018 · 20 September 2018 · 11 December 2018.

7. On 7 January 2019 Ms Z attended hospital with chest pain and sudden shortness of breath. A consultant suspected she may have a pulmonary embolism and arranged a VQ scan (a scan to examine air and blood flow in the lungs).

8. On 14 January Ms Z had the VQ scan. The radiology report said her scan appearances were consistent with a pulmonary embolism. A consultant diagnosed this and prescribed long term rivaroxaban.

9. On 17 July Ms Z had an appointment with a consultant haematologist. The consultant wrote to her GP following the appointment. They said as far as they could tell, the pulmonary embolism was an unprovoked event. The consultant said he repeatedly tried to explain to Ms Z through the interpreter in view of the unprovoked occurrence of pulmonary embolism it would be necessary to have long term anticoagulation.

Findings

Provision of Depo-Provera injections

14. Faculty of Sexual & Reproductive Healthcare UK Medical Eligibility criteria for contraceptive use offers guidance to providers of contraception regarding who can use contraceptive methods safely. The guidance allows clinicians to consider the possible methods that could be used safely by individuals with certain health conditions or characteristics to prevent an unintended pregnancy.

15. Some examples of these health conditions or characteristics are: · smoking · obesity · previous episode of venous thromboembolism (VTE: a condition in which blood clots form in veins located deep inside the body, usually in the thigh or lower legs) during pregnancy.

16. The guidance states there are no restrictions on the use of progestogen-only contraceptive injection (such as Depo-Provera) in women who smoke or are clinically obese.

17. The guidance says women who have had a previous episode of VTE during pregnancy are eligible to use progestogen-only contraceptive injection as the benefits outweigh the risk. This is because they are at a higher risk of experiencing VTE during further pregnancy, and so preventing a pregnancy would be safer.

18. The guidance says women should be free to choose their preferred method of contraception provided they are medically eligible.

19. We can see Ms Z self-referred to the family planning clinic and her first appointment was on 5 April 2018. The records from this appointment show Ms Z smoked, was overweight and had given birth two weeks earlier. The clinician made a record of previous VTE on the tick box checklist. They discussed the Depo-Provera injection with Ms Z and provided this.

20. Ms Z continued to have Depo-Provera injections throughout 2018.

21. On 7 January 2019 Ms Z attended hospital with chest pain and sudden shortness of breath and was ultimately diagnosed with pulmonary embolism.

22. Ms Z’s records show she told clinicians she had an episode of VTE during her pregnancy and was on Dalteparin (anticoagulant medication used to treat and prevent blood clots) for this.

23. On 6 February 2019, a consultant spoke with Ms Z’s GP. The GP advised they have no information regarding the previous VTE Ms Z spoke of. The GP said Ms Z had been with the surgery since 2014. The Practice has letters going back to 2008 and there is nothing about previous VTE.

24. Our adviser reviewed the clinic notes from 5 April 2018. They said Ms Z clearly stated she wanted the Depo-Provera injection. Ms Z was medically eligible for the contraceptive injection and therefore it was in line with the guidance that the clinician provided this.

25. Our adviser reviewed Ms Z’s records and said they can see she was a smoker and overweight. Both factors carry a much greater risk of VTE than the contraceptive injection itself. They noted Ms Z’s claim of a previous VTE during her pregnancy. They explained this would have carried the biggest risk of further VTE as women who experience VTE during pregnancy are at much greater risk of reoccurrence in future pregnancies.

26. Our adviser said we cannot say the contraceptive injection caused Ms Z to have a pulmonary embolism. This is because she had predisposing factors that made her more at risk of VTE in general.

27. We consider the evidence indicates the Trust provided Ms Z’s contraceptive injections in line with Faculty of Sexual & Reproductive Healthcare guidance. The guidance clearly states there is no known link between Depo-Provera contraceptive injections and VTE. The evidence suggests Ms Z had other predisposing factors besides a possible prior thrombosis that may have led to the pulmonary embolism even if she did not have the contraceptive injections. For these reasons, there are no indications of failings in this complaint.

Our Decision

1. We have carefully considered Ms Z’s complaint about The Dudley Group NHS Foundation Trust (the Trust). We are sorry to hear of the distress she experienced as a result of the events she complains about.

2. Ms Z says she had a pulmonary embolism (a condition in which one of the pulmonary arteries in the lungs gets blocked by a blood clot) because of Depo-Provera contraceptive injections the Trust provided. We have seen no indication that anything went wrong in the way the Trust provided Ms Z’s injections.

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