What are the requirements to get Motiva® Breast implants?
Breast implants are indicated for the following procedures in female patients:
- Breast augmentation for women of at least 18 years of age, including previous augmentation to increase the breast size and revision surgery to correct or improve the result of a previous breast augmentation surgery.
- Breast reconstruction, including previous reconstruction to replace breast tissue that has been removed due to cancer or trauma, or that has failed to develop properly due to a severe breast anomaly, as well as revision surgery to correct or improve the results of a previous breast reconstruction surgery.
Who should NOT get breast implants?
Breast implant surgery should not be performed in women with active infections anywhere in their body, existing carcinoma of the breast (without mastectomy), with advanced ﬁbrocystic disease considered premalignant (without accompanying subcutaneous mastectomy), any disease clinically known to impact wound-healing ability, tissue characteristics clinically incompatible with mammoplasty, any condition – or treatment – determined by the surgeon to constitute an unjustiﬁable surgical risk, and in women who are currently pregnant or nursing.
What complications might occur with breast implants?
Because breast implant surgery is more often performed using general anesthesia, it is associated with the same risks as other invasive surgical procedures. After breast implant surgery, patients might experience swelling, hardness, discomfort, itching, bruising, twinges and pain over the first few weeks. Potential adverse events that may occur with silicone gel-filled breast implant surgery include capsular contracture, rupture, changes in nipple and breast sensation, infection, hematoma/seroma, delayed wound healing, implant extrusion, necrosis, granuloma, breast tissue atrophy/chest wall deformity, lymphadenopathy, gel diffusion, gel fracture, breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and others. Talk to your doctor about other complications.
How long does the recovery process take after breast augmentation surgery?
The recovery process depends on your profile and other variables. During the first 48 hours, you might have an elevated body temperature and your breasts may remain swollen and sensitive to physical contact for a month or longer. Both should fade away over time. You are likely to feel tired and sore for several days following the operation. You could experience a feeling of tightness in the breast area as the skin adjusts to the new breast size. You should avoid any strenuous activities for at least a couple of weeks but should be able to return to work within a few days. Breast massage may also be recommended as appropriate. Always follow your surgeon advice for the post-operatory period.
Do breast implants interfere with mammography?
You should inform your examiners about the presence, type, and placement of your implants, and to request a diagnostic mammography, rather than a screening mammography. Breast implants may complicate the interpretation of mammographic images by obscuring underlying breast tissue and/ or by compressing overlying tissue. Accredited mammography centers, technicians with experience in examining patients with breast implants, and the use of displacement techniques are needed to adequately visualize breast tissue in the implanted breast. The current recommendations for preoperative/screening mammograms are no different for women with breast implants than for those women without implants. Pre and post-surgical mammography may be performed to determine a baseline for routine future studies in augmentation patients.
Can I breastfeed with breast implants?
Breast implant surgery may interfere with the ability to successfully breastfeed, either by reducing or eliminating milk production. Although most women with breast implants who attempt nursing have successfully breastfed their babies, it is not known if there are increased risks for a woman with breast implants or if the children of women with breast implants are more likely to have health problems. At this time, it is not known if it is possible for a small amount of silicone to pass from the breast implant silicone shell into breast milk during breastfeeding, or what the potential consequences might be. A periareolar surgical approach may further increase the chance of breastfeeding difficulties. However, the American Academy of Pediatrics has stated that there is no reason why a woman with implants should refrain from nursing.
How long do Motiva Implants® last?
Breast Implants are not lifetime devices. However, the life expectancy of a silicone breast implant cannot be precisely estimated, as there are many factors beyond the manufacturer´s control that can affect the longevity of a device. The time period varies from patient to patient. Some patients could need replacement surgery few years after the primary procedure while others can have their implants intact for 10 years or longer. Therefore, the life expectancy of the implant cannot be guaranteed. If you experience pain or a change in appearance please see your doctor. For safety, as well as the most beautiful and healthy outcome, it is important that you return to your plastic surgeon’s office for the follow-up evaluations prescribed by your doctor. Yearly visits are recommended to verify the device integrity. During the 10-year follow-up visit the surgeon should assess whether or not it is advisable to remove and replace the implants.
Which Motiva Implants® will give me a round look?
Motiva Implants® Round with ProgressiveGel™ PLUS, provides the highest projection and a complete filling of the upper pole. For the type of results mentioned, the recommended implants should be these. However, the desired results for each patient should be evaluated individually by the surgeon.
Which Motiva Implants® will give a more natural anatomical appearance?
Motiva Implants® Ergonomix® with ProgressiveGel ULTIMA, were designed for women who want a breast implant that offers the most natural look and feel possible; one that adapts to their natural movements and gives them confidence in their normal lifestyle situations. For the type of results mentioned, the recommended implants should be these. However, the desired results for each patient should be evaluated individually by the surgeon.
Based on what should I choose SmoothSilk® (SilkSurface®) or VelvetSurface® for my implants? Why does it matter?
Motiva Implants® surfaces try to mimic the cellular dimensions, enhancing the biocompatibility of the implants resulting in less abrasion and a controlled inflammatory response after breast augmentation, even in patients with active lifestyles, features that can decrease complications after breast augmentation. Choosing one surface against the other would depend on the surgeon preferences. The most used is SmoothSilk® (SilkSurface®) which has the smaller surface dimensions. Other surgeons prefer VelvetSurface® because it has a higher roughness. Both Motiva Implants® surfaces have low complications rates of less than 1%.
Motiva Implants® are divided into three categories: Round, Ergonomix® and Anatomical. What exactly is the difference?
Round implants provide a higher top and a more full-bodied appearance. They are the most common implants and are used in almost 80 percent of all breast augmentation surgeries.
Anatomical implants are often called tear-drop-shaped, because they are designed to simulate the shape of a natural breast. While the result with an anatomical implant is natural looking, the predeﬁned shape means the implant lacks natural movement and doesn’t shift with the body’s movements. As an example, see how noticeable the lack of movement is when this patient goes from lying down to standing up. The implant retains the same shape whether the patient is prone or upright.
Motiva’s Ergonomix® implants avoid this drawback using a unique gel which is very soft, allowing the implant to follow a women’s natural movement, holding a round shape when lying down and assuming a teardrop shape when standing. This gives a very natural appearance, both in look and feel.
What is the difference between Mini/Demi/Full/Corse?
The main difference is the projection size. This means that our MINI has the smallest projection, then our DEMI, following our FULL size and the biggest projection will be our CORSE. To select the perfect size, you should contact your surgeon who is going to select the implant projection depending on your torso and chest size,s as well as your final desired results.
Can you recommend a clinic/surgeon that uses Motiva Implants® in my country?
Are Motiva Implants® FDA approved?
No. In March 2018, Establishment Labs received approval for an investigational device exemption (IDE) from the FDA to initiate the Motiva Implant® clinical trial in the United States. Motiva Implants® are CE mark approved.
Where can I find more information about your products?
What is the Q Inside® Safety Technology?
The Q Inside® Safety Technology is the world’s first FDA approved transponder for use in humans. It was FDA cleared in 2004 and the only one with CE-Mark for use in a breast implant. It consists of a biocompatible RFID (passive radio-frequency identification) microtransponder which provides an electronic serial number that is accessed by an owned handheld reader (Motiva Q Inside® Reader Standard) when waved over the breast area for traceability post-implantation.
Motiva Implants® are available with and without a microtransponder. The microtransponder is a device which is placed in the breast implant filler material. It has been separately reviewed and cleared for marketing by the FDA for use as an implantable microchip that is inserted into the subcutaneous tissue of a patient to provide an electronic serial number that may be used to access a database containing the patient’s identity and health information.
What are the risks associated with the microtransponder?
The risks associated with the microtransponder include the following:
- Adverse tissue reaction
- Migration of the transponder
- Failure of the microtransponder to operate properly
- Failure of the inserter
- Failure of the electrical scanner
- Electromagnetic interference
- Electrical hazards
- MRI disturbances
These risks have been mitigated through the establishment of certain testing requirements by the FDA for this device, including the requirement to perform biocompatibility testing, migration testing, performance testing, electromagnetic compatibility testing, electrical safety testing, and MRI compatibility testing.