Silimed Europe Products/Instructions to Surgeons/Patient Info
Question:
**Cancer screening after implantation? ** **Mammography makes it possible to locate tumors. Using a special technique, **the Eklund-technique, mammography is also possible with women with breast **implants. Modern techniques like sonography, MRI or CT help to find tumors **early. 16-18 Even with eklund ~ tumors can be missed this is very misleading ~ dangeously so (but sure helps them sell implants)
Response:
I want to be off your mailing list please do so I did not ask to be put here – Hide quoted text — Show quoted text – **Independent of better surgical implantation techniques, micro-polyurethane **foam-structured implants in large studies show an impressive low rate of **capsular contractures of 0 – 3 % compared to 9 – 50 % with other **implants 1-13. Textured implants also show a clearly lower risk of capsular **contracture than the smooth walled implants. note the study below alexa recently posted on polyurethane Polyurethane or silicone as long-term implant substance–a critical evaluation [Polyurethan oder Silikon als Langzeitimplantatwerkstoff--eine kritische Wertung.] Biomed Tech (Berl) 1993 Jul-Aug;38(7-8):172-8 (ISSN: 0013-5585) Behrend D; Schmitz KP Medizinische Fakultat, Institut fur Biomedizinische Technik und Med. Informatik, Universitat Rostock. Long-term implants made from thermoplastic elastomers have a long history of clinical use. Among other rubber materials, such as polyolefin rubber, much of the demand for rubber-like biomaterials is met by silicone and polyurethane elastomers. The last two elastomers both have sufficient biocompatibility for long-term applications, but differ in terms of biodegradability. Inadequate resistance to degradation almost always leads to implant function loss, which may even threaten the patient’s life. Long-term implantation studies in the rat show different mechanisms of biodegradation for polyurethane and silicone. Polyurethane shown deep fissures in the surface, compared with erosion of silicone surfaces. Mechanical and electrical parameters determined to evaluate degradation, additionally show differences in the extent of damage occurring.
Response:
Hi Patricia I’m not familiar with Supernews. It looks like you must have signed up to receive newsgroup postings in your email. You’ll need to cancel through them. Let me know if you can’t figure it out and I’ll try to help you. I’ll go check out Supernews, too. Good luck
**I want to be off your mailing list please do so I did not ask to be put **here **
**
** ** **Independent of better surgical implantation techniques, micro-polyurethane ** **foam-structured implants in large studies show an impressive low rate of ** **capsular contractures of 0 – 3 % compared to 9 – 50 % with other ** **implants 1-13. Textured implants also show a clearly lower risk of capsular ** **contracture than the smooth walled implants. ** ** note the study below alexa recently posted on polyurethane ** ** Polyurethane or silicone as long-term implant substance–a critical ** evaluation [Polyurethan oder Silikon als ** Langzeitimplantatwerkstoff--eine kritische ** Wertung.] ** Biomed Tech (Berl) 1993 Jul-Aug;38(7-8):172-8 (ISSN: 0013-5585) ** Behrend D; Schmitz KP ** Medizinische Fakultat, Institut fur Biomedizinische Technik und Med. ** Informatik, Universitat Rostock. ** ** Long-term implants made from thermoplastic elastomers have a long ** history ** of clinical use. Among other rubber materials, such as polyolefin ** rubber, ** much of the demand for rubber-like biomaterials is met by silicone and ** polyurethane elastomers. The last two elastomers both have sufficient ** biocompatibility for long-term applications, but differ in terms of ** biodegradability. Inadequate resistance to degradation almost always ** leads ** to implant function loss, which may even threaten the patient’s life. ** Long-term implantation studies in the rat show different mechanisms of ** biodegradation for polyurethane and silicone. Polyurethane shown deep ** fissures in the surface, compared with erosion of silicone surfaces. ** Mechanical and electrical parameters determined to evaluate degradation, ** additionally show differences in the extent of damage occurring.
Response:
**Independent of better surgical implantation techniques, micro-polyurethane **foam-structured implants in large studies show an impressive low rate of **capsular contractures of 0 – 3 % compared to 9 – 50 % with other **implants 1-13. Textured implants also show a clearly lower risk of capsular **contracture than the smooth walled implants. note the study below alexa recently posted on polyurethane Polyurethane or silicone as long-term implant substance–a critical evaluation [Polyurethan oder Silikon als Langzeitimplantatwerkstoff--eine kritische Wertung.] Biomed Tech (Berl) 1993 Jul-Aug;38(7-8):172-8 (ISSN: 0013-5585) Behrend D; Schmitz KP Medizinische Fakultat, Institut fur Biomedizinische Technik und Med. Informatik, Universitat Rostock. Long-term implants made from thermoplastic elastomers have a long history of clinical use. Among other rubber materials, such as polyolefin rubber, much of the demand for rubber-like biomaterials is met by silicone and polyurethane elastomers. The last two elastomers both have sufficient biocompatibility for long-term applications, but differ in terms of biodegradability. Inadequate resistance to degradation almost always leads to implant function loss, which may even threaten the patient’s life. Long-term implantation studies in the rat show different mechanisms of biodegradation for polyurethane and silicone. Polyurethane shown deep fissures in the surface, compared with erosion of silicone surfaces. Mechanical and electrical parameters determined to evaluate degradation, additionally show differences in the extent of damage occurring.
Response:
This is currently their advertising on the web, Rogene? Are they really still making polyurethane foam covered implants?? BTW, how are Silimed and PIP implants related, if anyone knows? Scary stuff.
**I certainly don’t intend to advertise for Silimed breast implants . . . but **I think this group will find their patient information and physician **instructions interesting. ** **Please read the contraindications carefully! ** **Rogene ** **Silimed Europe Products/Instructions to Surgeons/Patient Info ** **A breast implant – for me? **Do you have questions concerning breast implants for the reconstruction or **augmentation of the breast? ** **In the following, we will inform you about breast implants and try to answer **the questions, which might be of concern. ** **Breast implants have been used since the early sixties. In this time more **than 2 million women have decided to have silicone gel filled implants. ** **The implants have constantly been improved. Cooperation between patients, **physicians and manufacturers enable constant adaptation to the latest **medical and technical knowledge. ** **The number of women who decide for a breast reconstruction (re-building of **the breast) after breast cancer has increased significantly during the last **few years. Breast reconstruction, but also augmentation, has become one of **the most performed operations in the field of plastic and reconstructive **surgery. ** ** What is silicone? ** **In the medical field silicone is used for a variety of products: probes, **catheters, coating of puncture needles and cardiac pacemakers, gloves and **wound coating. In the field of soft tissue surgery, implants are used for **body contour correction. ** **The first production process for silicone polymers was patented in 1958. ** **Silicone or, as chemists call it, dimethylpolysiloxan, is produced as **silicone elastomer, silicone gel and silicone oil. In silicones oxygen and **silicon are bound together in the same way as in stones and glass. **Additionally, methyl groups are bound to the silicon atoms. Except of **pyrogenic fluosilicic acid – very fine quartz (amorphous silica) – as a **filling and stabilizing material, silicone does not contain any other **additives, especially no softening agents. ** **Thus, a stable, chemically exactly defined implant material is available. ** ** **Are there different types of implants? ** **Yes. A broad variety of silicone implants are available. All present breast **implants have an outer silicone envelope. The form of the implants varies: **round, teardrop, anatomical, with high or moderate projection. For decades **the implants have been filled successfully with silicone gel and saline **solution. ** **Implants filled with highly cross-linked silicone gel are presently, **according to the state of the art, the best replacement for soft tissue. **Such a silicone gel has a "memory-effect", i.e. the gel always returns to **its given form. In its consistency, palpability and movement it imitates the **natural breast. ** **An important difference is the surface of the implants. The first implants **manufactured in the sixties were smooth-walled. Since the middle of the **seventies micro-polyurethane foam-structured implants have been used. At the **end of the eighties textured implants were introduced. ** **Nowadays three different surfaces are available. ** ** **Why do different surfaces exist? ** **As a natural reaction, the organism builds a capsule around any foreign **body, and therefore around an implant as well. ** **The capsule can tightly surround the implant and contract. This contracture **may change the shape of the implant and, therefore, the shape of the breast. **The capsule may become very firm and cause pain. This complication is called **capsular contracture. ** **How often capsular contracture occurs depends, among other factors, on the **implant surface. ** **Independent of better surgical implantation techniques, micro-polyurethane **foam-structured implants in large studies show an impressive low rate of **capsular contractures of 0 – 3 % compared to 9 – 50 % with other **implants 1-13. Textured implants also show a clearly lower risk of capsular **contracture than the smooth walled implants. ** ** **Do implants have to pass safety tests? ** **Yes. For many years, the safety and reliability of implants have been proven **constantly. 35 years of experience are the basis of their safety profile. ** **All over Europe, the Medical Device Directive and international standards **stipulate clear requirements for such products. Materials, development, **manufacturing, sterilization and packaging are subject to strict rules. ** ** **Does an implant change my physical appearance? ** **Yes. Using breast implants, an almost natural look, feel and movement of the **breast can be reached. 14,15 ** ** **Are there different surgical procedures? ** **Yes. Please ask your physician about the surgical procedure for breast **reconstruction and augmentation. Only your physician can individually inform **you about the different techniques and the possible risks involved with the **operation. ** ** **Cancer screening after implantation? ** **Mammography makes it possible to locate tumors. Using a special technique, **the Eklund-technique, mammography is also possible with women with breast **implants. Modern techniques like sonography, MRI or CT help to find tumors **early. 16-18 ** ** **What influence do breast implants have on cancer treatment? ** **In large studies it was evaluated that women with breast implants do not **suffer from breast cancer more often than comparable women without breast **implants. 19-23. ** **A breast implant does not have any influence on the occurrence of breast **cancer. The occurrence of breast cancer due to smooth, silicone textured or **micro-polyurethane foam-structured implants has not been observed in either **human beings nor in animal studies. In science, however, theoretical risks **are discussed. 24, 25. ** ** **Do micro-polyurethane foam-structured implants bear a greater infection risk **than other implants? ** **No! 26 ** ** **Is the risk of an autoimmune disease higher for women with breast implants? ** **No! ** ** **No plausible link between silicone gel filled implants and autoimmune **diseases could be proven. 27-33 ** ** **Can silicone gel permeate through the implant shell? ** **In contrast to previous generations of implants only negligible traces of **gel can be found in the connective tissue capsule, due to the significantly **improved quality of the implant shells and the gel consistency. 34-36 These **gel traces remain within the connective tissue capsule. ** ** **Is a manual external treatment of capsular contracture appropriate? ** **According to recent scientific knowledge the manual external treatment of **capsular contracture should not be performed because it may damage the **implant. ** ** **How long does an implant last? ** **Each host organism shows an individual reaction to a foreign body. Current **studies resulted in an average life expectancy of 10 years. 37,38. Because **of implant improvements a prolonged life expectancy of current implants is **expected for the future. The intactness of the implant and its correct **position should be checked by your physician every six months or yearly. ** ** **Implant passport and documentation ** **After implantation your physician will give you an implant passport. Please **carry it always with you, so the information concerning the type and size of **the implant is available at any time. For your own safety, please inform any **physician in charge about your implants. ** ** **How to prepare the counseling with your physician ** **Ask your physician everything you want to know. Prepare this conversation by **making a list of your questions regarding breast reconstruction or **augmentation. Discuss these questions with your physician. It is very **important that you make your own clear, personal decision before you undergo **surgery! ** ** **References ** **Baudelot, S. (1989) Assessment of four year’s experience with microthane **coated breast implants. Ann. Chir. Plast. Esth
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