Select Committee on Health Minutes of Evidence

Memorandum by Brenda Livsey (B10)

  I would like in the first instance, to endorse the written evidence regarding the above subject, submitted by my fellow Campaigner Rosalind Urion, dated 14th February 2001.

  I would, however, like to offer other concerns, the first expressed by Rosalind Urion in her memo under the title, The MDA/Biosil/Checks on Manufacturing Standards.

  With regard to the allegations against the Scottish firm Biosil, we have written to Health Ministers and the MDA through our MP's and MEP's. In the light of the specific criticism made by the United States Federal Drug Administration regarding Biosil, as quoted in the Scottish newspaper article of The Daily Record, 28th August 2000, we feel that campaigners and members of the general public should be entitled to a clear and point for point answer to our queries.

  Points of criticism include a list of manufacturing procedures not adhered to ie, failure to correct and prevent sub-standard implants being manufactured—failure to use approved methods in an element of the process—failure to use correct temperature of water in manufacturing—failure to maintain the correct levels of temperature humidity in the factory essential to the quality of the product, which therefore resulted in detrimental effects to the implants etc.

  It is necessary to look at these factors in the context of some of the website details of the IRG Report (see attachment 1).[49] Here we see that the information from manufacturers on the chemical constituents used in silicone gel implants was sometimes patchy and identification of the nature and source of materials tested was not always possible from the data provided. The Table shows that toxic chemicals such a Platinum are involved. The Detoxification process, it is said, depends on the |Curing", that being the heating of the implants in an Autoclave to the required temperature levels which also turns the liquid silicone into silicone gel. Now, although the Biosil firm in question was employed at its Cumbernauld firm to produce SALINE implants, it must be remembered that Biosil which is a NAGOR industry, also produces silicone gel implants at another factory in the Midlands, therefore, if standards and quality control are failing in one branch, the implications are that standards are not being met elsewhere in the Nagor empire. We were all made aware that the Department of Health do not carry out their own inspections at such factories, but engage independent "experts" to do the job. We are very concerned about this, especially when the Department of Health and the MDA were not aware of the US FDA concerns initially. When we ask about it, the MDA simply respond with replies telling us that there is no danger to public health. This blandly patronising response is unacceptable.

Reportage of Adverse Incidents/Information

  My comment on the system of the reportage of Adverse Incidents are as follows:

  I was one of seven women who complained to the Parliamentary Ombudsman about the MDA regarding the misleading information and their failure to take account of my report of implant failure. The Ombudsman, in part, upheld each complaint which went through the whole complaints procedure. As a Support Group Co-ordinator at that time, I was able to read some of the other women's reports and was interested to find that the MDA had claimed that they had lost the early letters from all of us, namely, those in which we told of our concerns of ill-health and implant failure. Fortunately, several ladies have retained copies of those letters. It was a surprise to me to learn in the Ombudsman's Report, that when questioned, the MDA said that they would not include the reports of ruptured implants from patients who had undergone a process known as "Closed Capsulotomy" as an Adverse Incident. Not at any time was this information imparted to me by the MDA, in fact it was never mentioned during any telephone conversations, that there was even an Adverse Incident Department. We dealt solely with Dr. Susanne Ludgate & Co. We were not given any helpful directions whatsoever, in fact, it was by searching through lots of Department of Health literature that I found out about the National Implant Register at the OddStock Hospital in Wiltshire. Trying to get information from the MDA was like trying to get blood out of a stone, and they were and probably still are very economical with the truth. A proper reportage system is crucial to the effectiveness of information.

  The MDA now claim that Adverse Reports on Breast Implants have decreased. This does not tally with the situation experienced by those trying to run Helplines. I believe that the problem here lies with the fact that (a) many plastic surgeons do not regard implant rupture as an adverse incident, (b) the MDA does not encourage reportage from the patients themselves, (c) the lack of awareness of the existence of the MDA, as well as the controversial nature of this problem, will have prevented a number of plastic surgeons from reporting back to official bodies, such as the Registry or the MDA (in my own case, my surgeon reported to neither), (d) the publication of the IRG Report seems to have led to a proof-of-safety interpretation amongst medical bodies. This may have increased a general lack of vigilance in terms of reporting adverse incidents of individual patient's medical devices. This also leads me to the latest revelation from the MDA that in their eyes silicone implants are "safe".

  I will quote sentences from a letter written to me by Jeremy Tinkler of the MDA, dated 22nd February 2001. "The three reviews carried out in the UK and others carried out abroad, have consistently concluded that there is no credible evidence to suggest that silicone gel breast implants pose an undue risk to health. In other words, the concensus conclusion of expert analysis is that these implants are "Safe".

  This conclusion by the MDA has existed since its inception in 1991; regardless of bans and moratoriums by at least five major countries and I wonder WHY?

49   Attachment not printed. Back

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