Introduction:

The first breast implants in
Silicone were first implanted in 1962. The first autoimmune diseases after silicone injections were described in 1964 by Miyoshi, the first connectivities (CT) after silicone breast implants by Van Nunen in
1982 (Koeger and Bourgeois, 1993). Are connectivities after silicone breast implants a reality? For 30 years, the issue remains highly debated because of the negligence of manufacturers, governments,
surgeons and doctors.
www.ipubli.inserm.fr/bitstream/handle/10608/201/expcol_1998_risques_24ch.pdf?sequence=35

Composition:

There are different types of breast implants, depending on their composition:

– silicone envelope filled with physiological solution;
– Silicone envelope filled with silicone gel
– volume of polypropylene. Allowing for extreme volumes and developed by Dr. Gerald W. Johnson, they are used in the pornographic industry.

First ways of breast augmentation
The approach is the incision that will be used by the plastic surgeon to insert the implant. In France, three incisions are used for the placement of prostheses:

– the periareolar approach that leaves a scar around the areola;
– the under-mammary route that leaves a scar in the under-mammary groove;
– the axillary way which leaves a scar in the armpit and no scar on the breast.

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Shape of breast implants

Nowadays, there are different forms of breast implants to discuss from the elements of the initial breast anatomy and the desired chest shape:
– round implants with different filling levels (low, medium or high profile), placed in the retro-glandular or retro-muscular position and which fill the neckline more in large volumes or high profile;
– Anatomical or profiled implants, called droplets, placed partially behind the muscle and used initially in breast reconstruction, find an aesthetic indication to limit the bulging of the breast in large volumes or when the breast has changed at following pregnancy or breastfeeding;
– the asymmetrical implants which have a shape adapted for each side, are placed in retro-glandular position and which are drawn according to the shape of the thorax (source WIKIPEDIA)

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Silicone

Silicone is an artificial polymer containing the silicon element, has been used in a variety of medical devices, including breast implants. Silicone has been used, in part, because it has been suggested to have the property of biological inertia. Inert materials do not affect chemical, physiological or immunological processes. Silicone is not inert. The silicone from the breast implants “oozes” through the surrounding wrap and is present in the surrounding capsule or migrates to other distant locations. Silicone and / or multiple chemical contaminants cause foreign body reactions associated with granulomatous inflammation and fibrosis. Silicone and its contaminants have the potential for significant toxicity in the implant recipient.

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https://www.ncbi.nlm.nih.gov/pubmed/7801134

Breast prostheses are class III medical devices.

JANUARY 13, 2017
ANSM: Summary of Features for Implantable Class III DMs and DMs

[2017-01-13] Law No. 2016-41 of January 26, 2016 on the modernization of our health system included an article 147 which contained the following text:
When national devices are put into service on the territory of the country, the list of which is fixed by order of the Minister of Health after the opinion of the National Agency for the Safety of Medicines and Health Products, the manufacturers or their authorized representatives shall transmit to the agency a summary of the features of their device. ”

It was specified that the content and modalities of transmission of the summary of the characteristics of the device would be determined by a decree in Council of State.
This decree was published in J.O. on December 15, 2016: Decree No. 2016-1716 of December 13, 2016 relating to the summary of the characteristics of the medical device. It indicates that the DMs concerned by the transmission of the summary of the characteristics of the device are (except the customized DMs):
– implantable DMs
– Class III DMs (the highest level of risk)

The summary of the characteristics (the content of which is detailed in the decree) must be sent electronically to the Director General of the ANSM (National Agency for the Safety of Medicines and Health Products) when the DM is put into service on the site. National territory. This transmission must be made for each trade name by the manufacturer or his authorized representative and by the distributors who deliver the DM directly to the user.
The decree comes into force on July 1, 2017.

Attention: in case of non-compliance with this requirement, the manufacturer or agent will be punished with a fine of 150,000 euros!

Notes:

We are very surprised not to find the exact composition of the prostheses both in terms of the envelopes and the content.
We would like to have the date of manufacture and the expiry date, and the exact life span of the implant 10 years, 8 years, 20 years.
The CE notification is the guarantor of the certification label.

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None of the manufacturers has so far submitted bio compatibility and safety tests; since ANSM has just demanded these tests from manufacturers last year.
Where is the list of known side effects?
The ANSM publishes no figures on the exact number of women implanted, explanted and reported adverse effects.
Are surgeons informing you about a possible autoimmune reaction to a foreign body or ASIA syndrome and possible LAGC (lymhome only found in breast prostheses)

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