Sensibilisation Aux Problèmes Des Implants.Médicaux

 

Levis, december 6th 1998

 

The Honorable Minister Of Health

Honorable M. Allan Rock

Tommorrow plants will fail

Questions of ethics and policy to be answered by the federal minister of health- issues topical for 1999.The following are areas where the Federal Department of Health should state its intentions and ets policies. Most of these have been subject to continuing dereliction of duty on the part of Federal authorities and, as a result, have attracted hostile media coverage. The areas deal principally with protection of the consumer from inappropriate medical procedures, faulty medical devices, improper human experimentation, unnecessary health care costs and fraud against provincial health insurance programs by segments of the medical community and associated industries.

The issues are particularly relevant in the context of reduction in Federal transfer payments for health care, ongoing provincial budget cutbacks for essential medical services and hospital closures. They are also relevant in the context of loss of essential health care personnel. Abuses by special interest groups that promote expensive and faulty technologies which benefit few for a short while and where costs from complications ultimately revert to the public are additional factors which lend urgency to the need for changes in policy. Existing policies in these areas and the ladk of foresight that they imply are embarrassing in the light of continuing retrenchment for services such as care of the aged, post-natal care, dental health for children, essential cardiac and ophthalmic procedures and many other areas which are presently the object of cutbacks and long waiting periods for individuals in need.

* In view of the Department of National Health and Welfare’s past policies of accommodation with industry and promoters in matters of non-essential technologies including plastic surgery devices, why is there a continuing lack of leadership?

-Why is there so little regulation of such products, even for the ones that are transparently faulty?

-What is the Department doing to protect the public from widespread promotion and une of currently marketed types of plastic and cosmetic surgery implants which have never been critically evaluated or approved for sale?

* Past Ministers of Health and Department officials publicly supported continuing use of cosmetic surgery implants in spite of sub-standard quality and endemic adverse reactions at a time when the material was under investigation by foreign agencies and entangled in litigation in the U.S.

-What basis has the public to believe that the Department has become more responsible in its approach to ensuring safety and efficacy in the products that it is supposed to regulate?

-What is the Department doing with respect to similar situations evolving in the U.S. in regard to saline mammary implants and quasi-cosmetic ophthalmic implants for myopla correction?

* There have been comparatively few organizational changes since the mid-eighties. The same core of indiniduals remain responsible for the regulation of drugs, medical devices, cosmetics and biologics at the Department of Health and Welfare in spite of investigations and official hearings on adverse reactions. The problems in the area continue unablted.

-What basis has the public to believe that policies that prevailed in the eighties, and that allowed tainted blood into Canada and breast prostheses made of indurtrial products, have now changed for the better?

* There is a current R.C.M.P. investigation of government wrongdoing in matters of breast implant regulations and recalls covering events of the eighties and nineties. The events as reported by the media, suggest collective incompetence, lack of commitment and dereliction of duty, as well as possible dishonesty on the part of many key members of the Department staff.

-What corrective measures does the Minister intend to take to prevent repetitions and worsening of the situation?

* Saline-filled breast implants are now the object of recalls and product discontinuation as well as emerging litigation in the U.S. These products have also been the target of increasing numbers unfavourable scientific publications and hostile press for more than two decades.

-What is the Department’s current policy with respect to these products?

* A similar situation is developing with respect to certain types of intraocular ophthalmic devices to resolve problems that are more easily and more safely corrected using conventional lenses and eyeglasses.

-What is the Department doing to prevent a repetition of the costly product failure and injuries from breast implants in the late-eighties in connection with adverse reactions this time involving the eye?

* Federal and provincial health care funding is dissipated in treating injuries from cosmetic surgery and the inappropriate use of implants for unnecessary purposes. Additional resources are spent in treating secondary diseases which result from plastic surgery implants, implants used for trivial applications better treated differently and other procedures with high risk components. There are additional costs which are incurred as a result of lost time for convalescence and for consumption of health care resources that are better needed elsewhere. There are also major socio-economic losses that are a frequent outcome of the misadventures.

-Why is there no federal-provincial agreement on mandatory warnings to be given by surgeons regarding " elective " implants and technologies which have a history of adverse reaction, frequent and foreseeable complications, enhanced risk of permanent injury from impact and trauma and periodic replacement?

-Why are provincial governments not inforned by federal authorities regarding the enormous health care costs associated with elective surgical procedures and faulty implantable products which must later be removed?

-Why in there no federal-provincial task force to establish strict medicare reimbursement policies for procedures that are non-essential and which have been habitually abused in many quarters, for example, elective mastectomies and " sham " mastectomies followed by insertion of mammary prostheses?

-Why are there no mandatory cautionary guidelines to the user that plastic surgery products and procedures entail risks and may lead to significant injury and disability?

-Why are users of cosmetic surgery products, which are non-essential and frequently of high risk, not required to sign a form stating that they will be responsible for costs arising from misadventures surrounding the products?

* Why are adverse reactions and failures from cosmetic and plastic surgery implants not subject to mandatory adverse event reporting, as is the case in the U.S.?

-What is the Department doing, if anything, to track adverse reactions?

* Why is the Minister of Health not briefed on rising costs associated with problem-prone urologic procedures, such as insertion of penile implants of obsolete and hazardous desings?

* What is the Department doing to follow up on current clinical trials on urologic products intended to achieve urinary continence by inducing fibrosis of tissus through injection of fine particles of plastic containing drug-like substances?

-What in the status of clinical investigations regarding the product " Urethrin " (Mentor) which appears to be a modern variant on an old technology which failed and left a long trail of injured patients in the sixties and seventies?

Due to the above questions, we are asking you to make sure that a public inquiry will be done in the Health Canada department.

You probably received the letter that we sent to the Honorable Prime Minister M. Jean Chrétien, concerning the article published by Reuters in the Ottawa paper.

We are still waiting for an answer .

As you probably know by now the SPR has come out in USA.

We hope that this report will not effect the Canadian women.

We can hear the big corporations laughting kind of loud at the moment.

Be sure that one day they will stop laughting.

We also hope that the USA law will not be in applicated here in Canada and that our true scientics will be able to comment on that report.

I hope that this time our letter will be taken in consideration,

On behalf of all the silicone victims here in Canada.

We are the evidence. We don’t think that the report of your study including Ontario and Quebec will be different from that SPR from USA.

Micheline B. Lambert, Présidente

Antonio Lambert, Vice-Président

Info Implants Mammaires Inc.

E-mail : delphine1939@videotron.ca

URL: http://www.info-implants.com




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