26 February 2018by Rédacteur4,571 CommentsNews and Press

Manufacturers in the world

 

Polytech Health
These implants are manufactured entirely in Germany in a factory near Frankfurt. Their range of prostheses covered with polyurethane foam is very wide. This specific foam makes it possible to use anatomical implants without risk of rotation and limits the shell phenomena to less than 1% of cases. We use these implants in more than 40% of our interventions.

Establishment Labs
With 30 years of experience and regulatory offices in the United States, a European distribution center in Belgium and a manufacturing facility in Costa Rica, Establishment Labs is the producer of next-generation breast implants with regulatory approvals in the United States. whole world.

The company creates the most advanced levels of security for women seeking to improve their appearance with proprietary Motiva technologies.

With the MOTIVA brand, these implants are made in Costa Rica. They have specific texturing (nano-texturing SilkSurface) and ultra-soft gel allowing ergonomix round implants to offer a natural look close to anatomical implants.

Mentor
Mentor is one of the two manufacturers of American breast prostheses. Their implants are made in Dallas Texas or Leiden in the Netherlands. The Laboratory is owned by Johnson and Johnson, one of the largest medical device laboratories in the world. Their round implants have been approved by the US FDA.

Allergan
Second largest US laboratory, acquired from the acquisition of McGhan / Inamed and CUI laboratories. Their implants are approved by the US FDA and are made in Costa Rica. Biocell macro-texturing appears to be implicated in double-shell phenomena and in more than 70% of cases of large-cell anaplastic lymphoma.

Groupe Sebbin SAS
The Sebbin group is a buyer of the Sebbin laboratory which went bankrupt.
This is a French laboratory whose production is entirely carried out near Cergy Pontoise, especially in case of custom implants.

Arion
It is a very innovative French laboratory, which offers a filling of implants by Hydrogel. Their production is entirely carried out in the south of France.

GC asthetics
With the French Eurosilicone laboratory, its production is located in the south of France at Apt. It has a range of textured implants.

Sientra
is a US-based company that has purchased the license to market Silimed implants made in Brazil in the United States. Sientra implants (Silimed) have recently been approved by the FDA to sell implants in the United States in 2012.

Cereplas (2014)
Summoned to be up to standard, the Northern company has not kept its promises and is caught by the health agency.

The breast implants of Cereplas are withdrawn from the market by decision of the Health Products Agency (ANSM). They are deemed not to comply with the regulations in force.

“Some manufacturing activities carried out by the company Cereplas are not in conformity with the regulation in force”, noted Monday the agency following sanitary inspections. “These include the mastery of the sterilization process and the qualification of equipment used in production,” she says on her website.

The company, based in the Nord department, had made compliance commitments. Because Cereplas did not live up to its promises, the ANSM decided to initiate a procedure of sanitary police of “suspension of the placing on the market, the export, the distribution and the use of the implants breast and templates of implants All the brand’s products are now all removed until they are brought into compliance.

CE marking certificates for these products have also just been suspended by the body authorized to issue these certificates.

For products already on the market and implanted, the elements provided by the company Cereplas lead to not jeopardize their safety of use, according to the health agency.

The latter adds that it “has no evidence to suspect the existence of a health risk” with these devices already used.

Poly Implant Prosthesis (PIP)
It was a French company founded at La Seyne-sur-Mer in 1991 by Jean-Claude Mas, who had been manufacturing breast prostheses since the mid-2000s. The company (which was liquidated in 2010) and its founder are at the heart of a public health scandal since the discovery in 2010 of the fraudulent and dangerous origin of the products.

The company was the world’s third largest breast implants sector1 with 100,000 units produced per year1. It exported nearly 80% of its production outside France1, particularly in South America and Eastern Europe1. About 300,000 women worldwide would carry PIP breast implants.
Leaders:
The market is fragmented with many players but dominated by the 5 leaders. Allergan, Mentor Worldwide, GC Aesthetics and Sientra have more than 85% market share in the global breast implant market.

The following companies:
POLYTECH Health & amp; Aesthetics GmbH, SAS SEBBIN GROUP, Establishment Labs SA, HansBiomed Co. Ltd., CEREPLAS, ARION LABORATORIES, Ideal Implant, Guangzhou Wanhe Plastic Materials Co., Ltd., Silimed, G & amp; G Biotechnology Ltd., Shanghai Kangning Medical Supplies Ltd., and Implantech Associates Inc.

The data collected to date do not show any warning signal on silicone breast implants. In general, the ANSM declares nevertheless to pursue the active surveillance of silicone breast implants, in an approach of improving safety.
In addition, PIP silicone gel implants are no longer marketed. They were the subject of two specific reports and regular updates of vigilance data (ANSM doc)

The ANSM health safety agency does not publish any figures each year with regard to implantations, explantations and adverse effects.
We are waiting for these figures.
 

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