Autoimmune Syndrome Induced by Adjuvants (ASIA) is characterized, in its most serious forms, by the development of autoimmune diseases such as skin diseases (scleroderma, lupus), or bone and muscle pain (fibromyalgia, rheumatoid arthritis).
In a report published in 1998, an American scientific jury (US National Science Panel), evaluated the scientific data concerning silicone mammary implants with respect to their relationship with connective tissue disorders and immunological dysfunctions. No relationship was established between mammary implants prefilled with silicone gel and any of the specified connective tissue disorders or any other autoimmune/rheumatic disease. It was established that women with silicone mammary implants did not present systemic anomalies of the types or functions of immune system cells that could be attributed to silicone. In 1999, an independent report presented by a committee of the Institute of Medicine in the United States indicated that connective tissue disorders, cancer, neurological diseases and other systemic diseases are no more common in women with mammary implants than in women without. This committee concluded that an examination of toxicological studies on silicones and other substances known to be present in implants did not give any reason for concern about health.
However, certain recent studies, notably those of Colaris et al., published in July 2016 in the journal “Immunologic Research”, suggest the existence of a risk of “Autoimmune/inflammatory syndrome induced by the adjuvants” (ASIA), which could be caused by incompatibility with silicone, with the following possible main symptoms: fever, muscle and joint pain, chronic fatigue, neurological manifestations and deterioration of cognitive faculties. However, the authors state that experimental and epidemiological data are lacking to confirm the existence of this risk. For prudence, implantation is not recommended in patients having personal or family prior history of such pathologies.
Sebbin offers a large range of quality standard and custom-made medical devices:
– Silicone implants (breast, gluteal, testicular, calf, thoracic)
– Facial implants (chin and malar)
– Skin expanders
– Lipofilling and scaffolds
An implant is made of a flexible envelope of silicone elastomer that gives a desired shape to the prosthesis and acts as a interface with the surrounding tissue. The envelope can either be sold empty to be filled with physiological saline by a surgeon during the procedure (implant called “inflatable”), or sold pre-filled with cohesive silicone gel.
Silicone is derived from silicon, which is found in sand. Silicon becomes silicone when combined with oxygen, carbon and hydrogen. It can be found in different forms: gel, oil or gum depending on the combinations of each chemical element that composes it. Silicone is an inert material used in medical fields since 1946. It has been used in the manufactuing of intraocular lenses, pacemakers and in the manufactuing of breast implants since 1963. Its main quality is lack of significant reaction with the surrounding tissue. Its mechanical qualities provide longevity and resitance.
To meet every patient’s needs, Sebbin offers a wide range of silicone implants with different shapes, textures and gel cohesiveness. Your surgeon can help you choose an implant that suits you, by taking precise measurements and photos of your chest. Thanks to an online virtual tool, you will be able to simulate the final result in augmented reality. Your surgeon may also suggest placing sizers in your bra to compare different possible projections of Sebbin implants.
When the implant is placed between the mammary gland and the pectoral muscle, you will experience very little pain after the surgery. You may only feel breast tension for a few days. When the device is positioned behind the pectoralis major muscle, you generally experience more pain and may require taking analgesics for a few days. The degree of pain is also directly linked to individual factors such as the right choice of the implant volume and the elasticity of the skin.
Breast implant surgeries must be performed by a trained and certified surgeon. A plastic surgeon is a surgeon qualified to perform plastic, reconstructive and aesthetic surgeries. You can consult international associations of surgeons such as ISAPS, EURAPS, FILACP, EASAPS to find recommendations.
When making your choice, do not hesitate to consult different surgeons as building a relationship betwen the patient and the surgeon that is based on trust is essential.
It varies according to various elements: the country you live in, the type of implant, the hospital the surgery is performed, the duration of the hospitalization, the fees of the surgeon and the anesthesiologist. Healthcare insurance may fund breast procedures in your country. However, purely asthetic procedures are usually fully financed by the patient.
An implant, even perfectly tolerated, can be perceptible, visible or detectable as a whole; it may be possible to palpate its peripheral edges. The perception of a device varies according to its positioning, its content and the thickness of the mammary gland and tissues. In general, the visibility is less in case of implantation behind the muscle. In reconstructive surgeries, after a mastectomy, the implant is always palpable regardless of its location, due to the absence of mammary gland.
Your surgeon and your anesthesiologist will need to know your medical history to perform your surgery smoothly. Your surgeon will recommend the incision side (sub-mammary, peri-areolar or axillary) and the positioning of the implant (under the mammary gland or under the pectoral muscle) in line with your morphology. You will be requested to approve and sign a standard consent form before undergoing your surgery.
In cosmetic surgeries, the implant is placed under the gland (retroglandular position) or under the pectoralis major muscle (retropectoral position). The incision is made either at the areola, under the armpit or in the fold located under your breast. The scars will be hidden around the perimeter of the areola. Breast enlargement procedure is usually a short surgery. It is performed in the operating room, under general anesthesia. During breast reconstruction procedure, implant is inserted throught the incision (scar) made when performing the mastectomy. The surgery may last longer.
You will be expected to spend 1 to 2 hours in the recovery room, where the anesthetic team will look after your wellbeing. In most cases, the procedure will be performed as a day surgery (the patient arrives in the morning and leaves at the end of the day), however you may be required to be hospitilized for 1 to 2 days. There will be a follow up consultation 5 to 10 days after your procedure.
After your surgery, a compression bandage may be applied to prevent the prosthesis from moving. Your surgeon will advise you to wear a supportive bra day and night. You may experience some pain which is the result of swollen breast and movement of pectoral muscle. Avoid the following: wide arm movement for 3 days, driving and carying heavy loads for the first 2 weeks, sport for 4-6 weeks, exposure to sun for 1 month and sleeping on your stomach.
Your surgeon will invite you for a follow up visit after your surgery. During the first year, a consultation is recommended at 3, 6 and 12 months and if during this time, you experience any concerns, your surgeon will advise the appopriate action which may include an MRI (Magnetic Resonance Imaging) or an ultrasound scan.
Breast reconstruction can be performed at the same time as the mastectomy. This is called immediate reconstruction. The duration of the surgery is longer than the delayed reconstruction but allows you to wake up with a new breast. Initially you will not see the final results, this could take several months until it settles. If the reconstruction is not performed immediately after mastectomy, this is reffered to as delayed reconstruction. It will require a second surgery and your patience while living without a breast.
For your peace of mind, Sebbin offers a compehensive lifetime warranty program covering its entire range of breast implants pre-filled with silicone gel. For further information, please consult your surgeon.
Generally there is no contradication to breastfeeding after breast surgery regardless of the type of the device. However, if during your surgery milk ducts were damaged, breastfeeding may be compromised. If a breast abscess appears during breastfeeding you may be required to remove the implant. A study, carried out by Semple et al, using silicon as a unit of measurement, found that the quantity of silicon in milk is identical in women with or without implants.
A breast implant is not a lifetime device. Like every biomaterial, it ages and wears out. There is no accurate lifespane for silicone implants. It depends on activities of the individual as well as the reaction between the body and the implant. It is generally advisable to consult your surgeon every 12 to 18 months for follow-up, and to change the implant every 10 years.
If you experience any particular discomfort, unusual symptoms, or have questions about your implant, contact your surgeon. He will be able to answer your questions and direct you to the appropriate resources.
Capsule formation around an implant is a natural reaction of your body.
Breast implants are foreign to your body. When such devices are placed in your body, the immune system’s natural reactions is to isolate the device by creating a capsule of fibrous tissue. The capsule formation occures in the first months following the operation.
The capsule depends on many things, including the surgical operation and each patient’s body reaction. The fibrous tissue around the implant can contract and may sometimes result in a hardening of the capsule, which in turn leads to hardening and deformation of the breast. This is called “capsular contracture”. This can occur on one side (one breast) or on both sides (both breasts). In most cases, the capsular contracture is mild.
Capsular contractures have been classified in four grades by Dr Baker.
– Grade I corresponds to the natural capsule formed around a foreign body, without any negative effect (the breast is normally soft and appears natural in size and shape).
– Grade II corresponds to the capsule which is firmer and perceptible. Some patients accept this result as they prefer the firmness of the breast.
– Grade III might have an aesthetic impact, as the capsule is visible through the skin and the implants start to deform. In most cases a re-operation may be required.
– Grade IV causes pain. The contracture tightness and deformation is stronger.
Symptoms of capsular contracture include: hardening of the breast(s), a deformed or displaced (higher on the rib cage) implant, ripples and wrinkles on the skin and breast pain.
If you experience any of these symptoms or other changes, notify your surgeon for further evaluation. He/She will be able to advise you.
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a cancer of the immune system. In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant. An individual’s risk of developing BIA-ALCL is considered to be low.
The main symptoms of BIA-ALCL are persistent swelling, presence of a mass or pain in the area of the breast implant. A warning sign would be a considerate amount of liquid around the implant. Repeated draining of the fluid may evoke the disease. If you experience any of these symptoms or other changes, contact your surgeon for further consultation (physical exam, imaging, and/or assessment of the fluid or tissue around the breast implant).
For most patients, ALCL is treated successfully with surgery by removing the implant and surrounding scar tissue. This disease seems to be able to be induced by the inflammation linked to the surface of the implants. Certain types of textures were recently banned by several countries because they represented a higher risk of developing BIA-ALCL, despite the pathology and exact origin of ALCL is not known. Following the first warning issued by the FDA (Food and Drug Administration) in 2016 on a possible association between some breast implant surfaces and the onset of BIA-ALCL, SEBBIN decided to launch, in collaboration with two laboratories, a PhD thesis on the biocompatibility of textures, which has now been completed. The results of this thesis made it possible to establish a new texture classification to avoid any confusion around the word “textured”.
Anaplastic large cell lymphoma (BIA-ALCL) remains very rare, however, all patients undergoing implant procedures must be informed of the possible risk.
(Source : “Surface texturation of breast implant impacts extracellular matrix and inflammatory gene expression in asymptomatic capsule. Plastic and reconstructive surgery”, Brigaud I, Garabedian C, Bricout N, Pieuchot L, Ponche A, Deltombe R, et al. Dec 23, 2019.)
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The headquarters are located in France, in Boissy l’Aillerie, in the Val d’Oise department near Paris. Sebbin has subsidiaries in several European countries: United Kingdom, Spain, Belgium and Switzerland (Benelux area), Germany and Austria.
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