Breast implants / silicone implants for the breast

Pioneer in quality

Breast implants have been Class III medical devices in Europe since 2003 and must therefore meet the highest safety requirements since 1 March 2004; POLYTECH Health & Aesthetics GmbH received approval for its products even before the directive came into force in December 2003. The company was one of the first manufacturers in the world to introduce CE marking for its products as early as 1995 and thus already complied with quality standards for Class III products at this early stage - long before French, British or South American companies made an effort to do so.

The range currently comprises around 1,500 implant types and is constantly being expanded. It mainly offers breast implants for women but also for men, as well as implants for the nose, chin, calves and buttocks, among others. "We offer doctors and patients a broad spectrum and can therefore offer the right solution for each individual case, whether for a reconstructive measure such as breast reconstruction after an illness or a purely aesthetic measure", concludes Hüser.

References:

¹ www.bfarm.de/DE/Medizinprodukte/riskinfo/empfehlungen/Silikon_Brustimplantate_PIP.html
² www.tagesschau.de/ausland/pip104.html

Allergan and Polytech confirm to patients and surgeons the quality and safety of the breast implants they sell and distribute

Marlow, United Kingdom, 9 January 2012 - Allergan, Inc. hereby reassures patients and surgeons using Allergan breast implants (NATRELLE™, McGhan™ and CUI™) worldwide that Allergan implants are not part of the current investigation by European regulators into breast implants manufactured by the French company Poly Implant Prothèse (PIP). It is important to emphasise that there are a number of different manufacturers of breast implants around the world. The health authorities are specifically concerned only with breast implants manufactured by Poly Implant Prothèse (PIP). Allergan conducts rigorous clinical development processes, extensive manufacturing and quality assurance reviews, and maintains a post-marketing surveillance programme to ensure the very high quality and safety of its breast implants, which patients and surgeons alike can rely on.

All Allergan implants are manufactured in a state-of-the-art facility using silicone and saline solution approved for medical use. They fulfil all relevant national and international quality standards and current Good Manufacturing Practice (CGMP). Allergan is audited many times each year by various regulatory authorities, including the relevant European authorities and the US Food and Drug Administration (FDA), to ensure continued compliance with all applicable regulations and laws. These include the European Medical Device Directives, FDA regulations and guidelines, International Organisation for Standardisation (ISO) standards and the company's own high standards. This approach enables the manufacture of all Allergan medical devices within a strictly controlled framework and in an established and validated process that leads to the consistently high quality of each item. An Allergan breast implant can take up to 12 days to complete, during which time the implant undergoes nearly 100 quality control tests, including material and product testing. These standards mean that every implant and tissue expander manufactured by Allergan is carefully scrutinised for quality and longevity.

In addition to the exacting standards to which Allergan implants are manufactured, the company strives to exceed quality standards for labelling, packaging, shipping and traceability for all of its products. These safety measures include the use of tamper-evident seals and precautions to prevent damage to the implants and to track their delivery. This makes it easier for Allergan to provide patients with up-to-date safety information about their breast implants.

Allergan's breast implants have been used successfully in more than 60 countries for almost 50 years and gel-filled implants are the most commonly used implants worldwide. Allergan's gel-filled breast implants have been extensively tested by competent health authorities worldwide. They carry the CE mark and have been available in Europe since 1997. The approval of gel-filled implants by the American FDA in 2006 is based on extensive data. This includes extensive preclinical studies of the company's medical devices, the use of gel-filled breast implants in more than 1 million women worldwide and data from nearly a decade of clinical studies involving more than 150,000 women with gel or saline-filled breast implants. This represents a total of more than 214,000 patient years.

Breast implants have been used since the early 1960s. Since then, silicone technology has improved to the extent that today's implants are manufactured with more standardised production parameters. Allergan implants are manufactured with advanced technology and a high safety profile: Thanks to the many refinements in product design and manufacturing, including silicone gels with increased cohesiveness, the additional barrier layer that differs from previous models, and a thicker shell that can withstand a load 25 times that of a normal mammogram without degradation. In addition to the advanced cohesive silicone gel, Allergan's breast implants provide further security through the use of INTRASHIEL™ Barrier Technology. The INTRASHIEL™ shell consists of multiple high-performance layers of silicone designed to act as a barrier.

Silicone gel-filled breast implants are among the most extensively studied medical devices with more than 3,000 peer-reviewed and published studies, including epidemiological studies, confirming the safe use of the implants. In June 2011, the FDA issued a report for clinicians and scientists on the latest findings on the safety of silicone gel-filled breast implants. This report confirmed the safety and effectiveness of gel-filled breast implants when used as directed.

Health authorities in all countries, the medical profession and manufacturers such as Allergan agree that breast implants, whether filled with saline or silicone, are not lifelong medical devices. As a result, implants may need to be removed or replaced during a patient's lifetime. Allergan endorses the recommendations of the health authorities of all countries, which suggest conscientious care of the implant patient by the treating physician. We recommend that patients with breast implants follow their routine medical care and speak with their physician if they notice any abnormalities. We also recommend that women who have concerns about their breast implants speak with their plastic surgeon.

As the world's leading manufacturer of speciality pharmaceuticals and medical products, we are committed to the science of aesthetic medicine. This includes providing very high quality products and information to patients and surgeons. For nearly 30 years, Allergan medical products have led the advancement of aesthetic breast augmentation and Allergan has always been committed to advancing the science, safety and quality of breast implants and surgery.

PIP breast implants

Dear patients,

Here is another update on breast implants from the manufacturers PIP (Poly Implants Prothèses) and Rofil Medical Nederlands:
In a joint press release from the German Society of Plastic, Reconstructive and Aesthetic Surgeons (DGPRÄC), the German Society of Senology (DGS) and the German Society of Gynaecology and Obstetrics, a precautionary implant removal "without haste" is advised.

For women who do not have a precautionary removal performed, a future risk of rupture cannot be ruled out. The danger lies in a false sense of security in imaging procedures. "Added to this is the potential toxicity of the non-compliant gel, which is still barely known. There are indications that the implants are increasingly "sweating out", i.e. silicone is being released into the body through the shell. If this suspicion were to be confirmed, the six-monthly testing of the implant, which is always recommended, would be pointless and the indication for removal would be even stronger. However, we will have to wait for further analyses and investigations by the Federal Institute for Drugs and Medical Devices (BfArM)," explains Prof. Vogt, President of the DGPRÄC.

The costs
This question is also likely to be decisive for the question of costs. If the procedure is medically indicated, the health insurance companies are responsible. Prof Wallwiener confirms: "... the patients subsequently participate "appropriately" in accordance with §52 SGB V if the initial procedure was not a reconstruction but an aesthetic procedure. However, according to the current legal situation, implant replacement is not provided for purely aesthetic corrections." "As soon as the situation has been finally clarified, the BfArM has the data from the federal states and further experience from implant removals is available, we must enter into dialogue with the payers in order to support our patients in this emergency situation caused by criminal energy", Prof. Vogt makes clear and advises patients to wait for these developments in dialogue with their surgeon if the risk is acceptable.

The consequence: acting together
According to recent reports, the European Commission is planning to amend the authorisation of medical devices. Prof. Vogt: "There is an urgent need for close dialogue between politicians, supervisory authorities, professional associations and bodies to optimise medical device approval and monitoring." Among other things, they propose stricter and unannounced inspections at the manufacturer's premises. "The ongoing on-site quality controls of the US Food and Drug Administration (FDA), which ensure continuous risk assessment and thus increased patient safety, could serve as a model", explains Prof Vogt and adds that the manufacturers' quality reports and ongoing studies can also be accessed there...

For further information, please continue to refer to the Links listed below.

Of course, I am still at your disposal if you have received an implant from the above-mentioned manufacturers or if you are generally unsure.

Your health and safety are important to us!

Dr Michaela Monatanari as a studio guest on cheap breast implants on WDR, Lokalzeit Ruhr, 04.01.2012

WAZ 03.01.2012:
"Breast scandal is spreading"Current topic: PIP breast implants

Dear patients,
As you will no doubt have heard from the media, the French Ministry of Health has made a decision in the case of defective breast implants from the manufacturer PIP (Poly Implants Prothèses) and the company Rofil Medical Nederlands. The patients affected have been asked to have their implants removed as a precautionary measure.

Firstly, I would like to emphasise at this point, that I have never used these cheap implants from France or the Netherlands. In my practice, I only use quality implants from the two leading companies Polytech (Germany) and Allergan (USA). Breast augmentation with autologous fat also plays a major role.

Nevertheless, if you have had an implant from the manufacturer PIP implanted or are generally unsure, I will be happy to talk to you. As an expert in breast surgery, you can rely on my experience.

Removal of the implants

On the subject of removing implants, here is the statement of the German Society of Plastic, Reconstructive and Aesthetic Surgeons, of which I am the deputy chairperson in NRW:

"However, according to the French supervisory authority, there is no need to rush", explains Prof Dr Peter M. Vogt, President of the German Society of Plastic, Reconstructive and Aesthetic Surgeons (DGPRÄC). "Removal appears to make sense as the implants rupture more quickly and the silicone that then escapes is difficult to remove. However, the French Cancer Institute has not yet been able to prove a carcinogenic effect of the faulty gel. The French committee of experts will meet again on 5 January 2012. In any case, we agree with the French recommendations and will inform our members accordingly. The implants in question are products from the manufacturers PIP and 'Rofil Medical Nederland' (identical to PIP)."

It is important to check the implants first:

"... Affected patients should see their doctor and have the implant checked, for example by ultrasound. If the implant is intact, there is definitely no danger for the time being, but the implant should continue to be checked at least once a year", advises Prof Vogt and adds that, in his opinion, patients should wait for further investigations before removing implants. A decision aid for patients can be found on the website of the Federal Institute for Drugs and Medical Devices. The opinion of the French expert commission announced for Friday should be awaited in any case.
Patients can find out whether their own implant is a product from the manufacturer PIP ("Poly Implant Prothèse") in their implant passport or from their surgeon.

Costs incurred

"Unfortunately, it can be assumed that those affected have often explicitly sought out a low-cost provider. These women in particular are likely to face financial problems with the costs of implant removal", fears Prof Vogt. It must be prevented that patients decide against removal for cost reasons and risk their health. According to Prof Vogt, the DGPRÄC is currently endeavouring to find out how many patients have been treated by plastic and aesthetic surgeons with the implants in question. As soon as this figure is available, the cost bearers and the Federal Ministry of Health will be contacted to find out how the costs can be covered by the health insurance funds. It may then be possible for the patient to share the costs in accordance with SGB V § 52 (2). How to proceed with non-ruptured/leaking implants in terms of costs has not yet been clarified. In an interview, the National Association of Statutory Health Insurance Funds has so far promised treatment in cases of medical necessity, but has also announced that it will hold patients liable in accordance with SGB V § 52 (2). "It is a question of state welfare to ensure that the implants do not remain in the body for cost reasons", emphasises Prof. Vogt.

The authorisation process for medical devices must also change, because this case:

... makes it clear that this case, which is probably unique in the history of medicine, could only come about because the approval of medical devices is apparently very porous. "Neither the treating doctors nor the patients had any idea what they were letting themselves in for. In my view, it is a question of decency to draw political consequences here and not to leave those affected alone", concludes Prof. Vogt and announces that he will campaign strongly for a change to the medical device authorisation regulated at European level.

For you, as a future patient, this shows once again how important quality and reliability are in any type of cosmetic surgery and wrinkle treatment.

You can expect a competent and empathetic practice team with an interdisciplinary network for plastic and aesthetic surgery at the highest level. Our benchmark is you, your ideas and requirements. In all aesthetic procedures, we aim to achieve and maintain a natural appearance.

Your trust, your satisfaction and your well-being are important to us!

For further information, here are some interesting, informative links:

https://www.dgpraec.de
http://www.bfarm.de
http://www.stern.de
http://www.spiegel.de
http://www.afssaps.fr

TV report "Faulty breast implants", Guten Abend RTL, 03.01.2012

The dream of perfect breasts. It has now become a nightmare for 100,000 women. Many of them are cancer patients who only wanted to rebuild their bust size. But the filler in the implants is apparently harmful and comes from NRW, among other places.