Select Committee on Health Appendices to the Minutes of Evidence



Memorandum by Dr Sarah Myhill (B 2)

  I am a general practitioner with a particular interest in chronic fatigue syndrome. Over the past twenty years I estimate I have seen over 1,500 cases of chronic fatigue syndrome largely caused by viral infection but an important subgroup of over 100 patients are those whose chronic fatigue syndrome follows silicone breast implants. During the early years I reported these cases individually to the Medical Devices Agency, but when it became clear to me that they took no action whatsoever to investigate these cases further, I gave up reporting. More recently I have simply told them the numbers of patients affected and the symptoms from which they suffer. The Medical Devices Agency has not asked for any further information nor investigated any of these either as a group or singly.

The problems from which these patients suffer in order of importance are:

    —  Chronic fatigue syndrome characterised by severe physical fatigue, wide-spread muscle pain and symptoms of early dementia caused by systemic leakage of silicone.

    —  Implant hardening—this is often treated by surgeons who crush the breast with its implant between their hands thereby rupturing the implant and accelerating other problems

    —  Autoimmune disorders causing severe arthritis

    —  Nerve damage such as peripheral neuropathy and multiple sclerosis

    —  Spontaneous implant rupture resulting in local migration of the contents. 50 per cent of implants are ruptured at twelve years, 95 per cent at 20 years.

  The Medical Devices Agency has not investigated a single one of these cases either individually or as a group despite information being made freely available to them.

  Furthermore, these concerns are not being sent to plastic surgeons and recommendations made by the Independent Review Group have not been instigated. In particular:

  1.  Patients are not being given information by their plastic surgeons about these concerns following breast implantation. There is no informed consent. Patients are still being told their implants will last for life with no complications.

  2.  There is no compulsory register for breast implant recipients, therefore, long-term problems go unreported. Voluntary registers are a waste of time because nobody does them, particularly the plastic surgeons who do not want to find out that they are directly responsible for so much ill health.

  The result of this inaction by the MDA is that those very concerns which have been identified by the IRG and are widely reported in the medical literature stand no chance whatsoever of being investigated further.

  For example it should be generally recommended that implants should be replaced every eight years before they rupture. Why has this not been done?

  If these cases are not being investigated then Government is not being put in a position whereby it can provide good information to those patients and surgeons considering a breast implant.

  I have written many letters to the MDA and others with no response. I think it is time for direct action. So please give the MDA a kick on the shins from me.

February 2000

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