Fw: Germany - Status of the official risk assessment of silicone gel-filled breast implants

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From: " Kathi " <pureheart@...>

Sent: Thursday, October 10, 2002 12:55 PM

Subject: Germany - Status of the official risk assessment of silicone

gel-filled breast implants

> Thanks Carolyn!

>

> (translation of announcement from BfArM, Germany)

>

> Status of the official risk assessment of silicone

> gel-filled breast implants

>

> September, 2002

>

> According to the present state of the available scientific

> knowledge as well as the risk assessment at the European level a

> prohibition of silicon gel-filled breast implants is not indicated in

> the view of the BfArM. Certain indications justify the application of

> these products in spite of existing risks.

>

> The risks can arise either from the implants or from the

> required surgical intervention.

>

> It has been shown that all sorts of breast implants can

> lead, independent of filling material, to side effects, as for example

> capsule hardening (or capsule fibrosis) or other local complications. In

> addition, other very complex clinical pictures have been observed with

> some patients and the causal connection is not determined for silicone

> implants, however. Besides, risks can be affected by patient-specific

> parameters (e.g., preexisting disease). In addition it must be

> considered that breast implants have fundamentally a limited lifespan.

>

> Today there are still no long-term studies available for

> alternative filling materials to silicone gel such as saline solution or

> hydrogel and particularly for hydrogel. Breast implants with soy oil as

> a filling material should no longer be used given the present state of

> knowledge; they were recalled in March, 1999 from the market.

> (Additional details on the homepage of the BfArM under " medicine

> products - news " ).

>

> The cover of a breast implant always consists of firm

> silicone, the risks from this silicone cover continue independent of

> filling material.

>

> The medicine product law places equally high safety demands

> on all breast implants, no matter for which indication they are to be

> used.

>

> With the silicone breast implants now available it is to be

> assumed that during the last few years there has been an advancement of

> the products. In this connection, refer to the " announcement of the

> commission about measures of the community and member states in

> connection with breast implants " of 15/11/2001 (http: //

> europa.eu.int/comm/enterprise/medical_d evices/index.htm). The BfArM has

> actively participated in the different phases of the development of this

> commission announcement and reiterates the positions represented in the

> adopted version. In appendix 1 of this announcement fundamental safety

> demands and procedures are specified for the conformity evaluation in

> accordance with directive 93/42/EWG on medical products including breast

> implants. Within the framework of the conformity assessment risks from

> the materials or products must be minimized as much as possible.

>

> For silicone breast implants a strict position on

> indications is needed in the view of the BfArM, particularly with

> certain high-risk groups, i.e., for example, patients with preexisting

> diseases, receiving radiotherapy, as well as with nonmedically required

> interventions. Special demands are to be placed in every case on

> presurgical consultation and aftercare.

>

> From conversations with patients and from the evaluation of

> case documentation it is be clear that frequently there is a serious

> lack in the discussion and clarification of the patients. They must be

> shifted into the position of being able to decide in an intense talk

> between doctor and patient as well as on the basis of extensive written

> information about the possible risks for or against an intervention.

>

> Of crucial importance is the availability of corresponding

> information for doctors and patients. In appendix 2 of the commission

> announcement named at the top a stand is taken on information for women

> considering a breast implant.

>

> EQUAM (European Committee on Quality Assurance and Medical

> Devices in Plastic Surgery) by order of the EU commission created

> patient information and consent for breast implantation which was

> published as annex II to MEDDEV 2/5/6-rev/1 in English, it can be

> recalled. A German translation is available to prospective customers on

> the homepage of the BfArM under " medicine products - news " . This patient

> information published in EU documents can serve as a basis of a

> confident talk between doctor and patient.

>

> The discussion about silicone gel filled breast implants

> should still continue in the view of the BfArM. The federal institute

> will observe carefully other developments. If new knowledge arises, it

> shall be examined whether the resulting consequences make necessary the

> risk assessment of the products.

>

> Brochure: Patient information and consent form for brest implants

> (in German) is at

> http://www.bfarm.de/de_ver/medizinprod/medprod_akt/Patienteninfo.pdf

>

>

> http://www.bfarm.de/de_ver/medizinprod/medprod_akt/AR100601.html

>

>