Sientra breast implants with high-strength cohesive silicone gel are only available through board-certified or board-eligible plastic surgeons. For more detailed information about the risks and benefits of Sientra breast implants, please visit /resources or call Sientra at 888.708.0808. Key complications include capsular contracture, implant removal, rupture and reoperation. Breast implant surgery is contraindicated in women with active infection anywhere in their bodies, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions and, who are pregnant or nursing. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery. Breast reconstruction includes primary 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 abnormality. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of primary breast augmentation surgery. IMPORTANT SAFETY INFORMATION: Sientra’s Silicone Gel Breast Implants are indicated for breast augmentation in women at least 22 years old and for breast reconstruction. In addition, the majority of these women indicated that their breast implants made them feel better about themselves. Most women who underwent primary or revision-augmentation with Sientra Implants felt their breast implants made them feel more feminine and more attractive. In Sientra’s Clinical Study, most primary and revision-augmentation patients were pleased with the results of their implant surgery. Most women who have undergone breast implant surgery have reported high levels of satisfaction with their body image and the shape, feel and size of their implants. Women choose primary breast augmentation surgery to increase the size and proportion of their breast(s). 4 SIENTRA BREAST IMPLANTS ARE FDA-APPROVED AND SAFE DEVICES THAT OFFER MANY QUALITY OF LIFE BENEFITS FOR WOMEN. Patients should contact their board-certified plastic surgeon with any changes to breast shape or size, including pain, lumps or swelling. The FDA and leading medical societies currently do not recommend changing the routine medical care and follow-up for women with implants. The FDA and all leading medical societies currently do not recommend the removal of implants in women without symptoms. Long-term clinical and real-world data supports the safety of breast implants. For any woman who is concerned about their breast health, they should see their board-certified or boardeligible plastic surgeon for evaluation. It is important for women to be advocates for their breast health and be aware of any changes in size or shape of their breasts or breast implants. The risk of developing ALCL from a breast implant is 0.003%. It is important to understand how rare the occurrence is and put the numbers into perspective. 6 When caught early, BIA-ALCL is usually curable. 2,3Ĭurrent data suggests that BIA-ALCL occurs more frequently in women with textured implants than smooth implants.4 BIA-ALCL has been diagnosed in women with silicone and saline implants.5 Worldwide, the reported incidence rates of BIA-ALCL vary widely and within different implant surfaces. Women with breast implants have a small but increased risk of developing this. BIA-ALCL is a rare and treatable type of non-Hodgkin T-cell lymphoma. 1 This means 14 out of 100 patients may experience capsular contracture within 10 years after receiving implants.* BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL)īIA-ALCL is NOT breast cancer. Through 10 Years, in general, a patient’s risk of capsular contracture is 13.5%. It can result in firmness or hardening of the breast. This means 8 out 100 patients may experience a rupture through 10 years.* CAPSULAR CONTRACTUREĭuring the healing process after surgery, in some women, the scar tissue (capsule) squeezes the implant. Through 10 Years, in general, a patient’s risk of developing a rupture is 7.9%. Below are a few of the key complications associated with breast implant surgery reported in Sientra’s 10-Year Clinical Study. It is important for women to know that complications may occur after surgery with breast implants. Women should always talk to their board-certified or board-eligible plastic surgeon about the different implant options, the known benefits and risks associated with any procedure, and their individual needs, to make an informed decision. We entrust patient safety and satisfaction to only the most qualified surgeons in our industry, which is why we offer breast implants exclusively to board-certified or board-eligible plastic surgeons in the United States. Undergoing any surgical procedure involves risks.
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