For the complete list of questions, download the full pdf. Evolution and update on current devices for prosthetic breast reconstruction. If you have textured gel or textured saline breast implants, allergan will cover. Surface areas of textured round breast implants were calculated from. The first time a breast implant is placed for augmentation is called. Healthcare providers who implant explant allergans breast implants are required to comply with device tracking regulations per 21 cfr part 821 by. They vary in material, size, and profile or projection. Natrelle breast implants, manufactured by allergan, are fdaapproved for breast augmentation and breast reconstruction. Allergan natrelle collection breast implants warranty. Class action lawsuit alleges recalled allergan biocell breast. Print it out and bring it with you to your consultation. Natrelle breast implants are approved for women for the following. All natrelle gel breast implants that have been implanted in the united states between june 1, 2009 and december 31, 2009. All natrelle saline breast implants that have been implanted in the united states on or after june 1, 2009.
The recalled breast implants represent less than 5 percent of implants sold in the united states. Sep 25, 2015 the natrelle 410 breast implant allergan, inc. Biocell textured natrelle round silicone implants and attended clinic visits at. Warranty info for allergan breast implants natrelle. From 2014, the authors started ultrasonography on annual visits. Breast implantassociated anaplastic large cell lymphoma is not breast cancer, the lawsuit clarifies, and is found in the scar tissue and fluid near a breast implant. A large, multicenter, 10year observational study is comparing the longterm safety and effectiveness of natrelle silicone breast implants versus saline implants or national norms.
Allergan markets a portfolio of leading brands and bestinclass products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. Steven turkeltaub breast augmentation involves the insertion of silicone or saline implants into the breasts in order to improve their size and shape. Posted on september 1, 2015 in breast augmentation, breast implants, gummy bear silicone implants, natrelle 410 silicone implant, saline implants, silicone implants by dr. Jan 01, 2009 this study included the types of natrelle salinefilled breast implants that were available in 1995, when the study began. Breast augmentation for women at least 18 years old for salinefilled implants. Shaping the future with you only natrelle does gummy. Natrelle siliconefilled breast implants are dry heat sterilized and are available in both smooth and biocell surface texture. Natrelle salinefilled breast implants directions for use. Please see important safety information, including boxed warning. What is your experience with natrelle gummy breast implants.
Breast augmentation is one of the most common cosmetic surgical procedures performed in the united states. Made to order some products have been indicated as made to order. Allergan breast implant recalls list of affected models. Ultimately, your surgeon will help you determine what kind of implant best fits your body, and your goals for your surgery.
Consult the coolsculpting system user manual for a complete list of contraindications, warnings. You will likely need additional surgeries on your breasts due to complications or unacceptable cosmetic results. Tenyear results from the natrelle 410 anatomical formstable. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. The 410 natrelle implants, which are textured, shaped, highly cohesive silicone gel implants, made by allergan, were recently approved by the fda for use in breast augmentation as well as in breast reconstruction.
Additional notes regarding the natrelle style 410 breast implants. Relative contraindications for 410 natrelle breast implants. Page 1 introduction directions to the physician the information supplied in this directions for use document is intended to provide physicians an overview of essential information about natrelle siliconefilled breast implants and natrelle inspira breast implants, including the indications for use, contraindications, warnings, precautions, important factors for a patient to consider. Pdf natrelle silicone breast implant followup study. Use allergan partner privileges to take your practice to the next level. On top of that, the allergan corporation gives further price reduction on natrelle implants to doctors who purchase a lot of botox cosmetic, juvederm, kybella, and latisse. Choose any style and size of natrelle gel breast implant for replacement in the. Mentor cpg gel breast implants are filled with a highly cohesive gel and have a unique, tapered appearance. Volume 7, number 1 natrelle implants for augmentation 71 drug administration requirement. The following are warnings associated with natrelle siliconefilled breast implants and natrelle inspira breast implants. Natrelle 410 extrafull projection silicone breast implants.
Unlike round breast implants, cpg breast implants are teardrop shaped, meaning theyre thinner at the top and gently slope to a fuller projection point near the implants bottom to mimic the silhouette of a natural breast. Natrelle offers implants in different sizes, projections how far forward from your chest wall the implant comes when youre standing, and fills the number of cc of silicone or saline the implant contains. Natrelle product catalogue pages 1 50 text version. Recipients of natrelle style breast implants are already protected against rupture or deflation with allergans confidenceplus warranty program. Natrelle breast implants allergan natrelle, mentor, and sientra are the big three in terms of breast implant companies in the united states. The natrelle collection has a broad range of implants with a design for your body type and breast augmentation or enlargement goals.
Section i important information for women about breast augmentation with natrelle gelfilled breast implants section ii forms. Allergans natrelle round siliconefilled breast implants were approved by the u. Natrelle inspira breast implants now offered by dr. Breast implants are not lifetime devices, and breast implantation is not necessarily a onetime surgery. The fda has not released the exact number of implants affected. Breast augmentation for women at least 18 years old. Breast augmentation with natrelle siliconefilled breast implants aug patient labeling rev 4609 page 1. Allergans july 2019 biocell textured breast implant recall doesnt include its smooth or microcell breast implants or tissue expanders, which have a much smaller risk of biaalcl. The natrelle collection combinesthe form stability benefits and a naturalfeel implant 2,4 control over final breast shape 1 constant distribution of gel throughout the shell in any position optimal gel fill one breast feel single unified breast mound 1 optimal longlasting shape control 1, 8, 9 better longterm maintenance of breast.
This study included 345 women with 460 implants 379 breast reconstruction and 81 contralateral breast augmentation, all of them were natrelle 410 breast implants who had undergone breast reconstruction surgery after mastectomy from 20052010 in our institute. Bucky has found it to be an excellent choice for many women seeking breast augmentation, breast revision, or breast reconstruction surgery. Breast augmentation with natrelle siliconefilled breast implants. Featuring our highest volume fill for a fuller upper pole and truform gel that is firm and offers the softest feel.
Natrelle product catalogue pages 51 56 text version. Considering silicone gelfilled breast implant surgery 11 1. Natrelle siliconefilled breast implants and natrelle inspira breast implants. General and plastic surgery devices panel march 2526, 2019 fda. All implants they produce are fda approved, and thus have been rigorously tested and found to be safe. Actual natrelle inspira breast reconstruction patient. Table of contents indications and important safety information 2 natrelle the most complete portfolio 8 the natrelle inspira collection natrelle 410 anatomical gel breast implants 23 natrelle salinefilled breast implants 31 natrelle 3plus tissue expanders 36 natrelle 3 tissue expanders 41 natrelle tissue expander accessories 46. Natrelle salinefilled breast implants allergan, santa.
This means the product is not stocked and will only be manufactured on receipt of a confirmed order. Sep 24, 2019 the 24page complaint states that the fda in 2011 identified a link between breast implants and biaalcl, a type of nonhodgkins lymphoma. Any time there is another surgery to replace the implant, it is referred to. You should become familiar with and use the following components provided in this planner. Breast augmentation for women at least 18 years old for saline filled implants. The information supplied in this directions for use document is intended to provide physicians an overview of essential information about natrelle siliconefilled breast implants and natrelle inspira breast implants, including the indications for use, contraindications, warnings. Along with this download you will receive a pdf of the directions for use in a compressed. In addition to silicone gel and saline choices, a womans implant is based upon breast width, projection, and volume. Do not use the product if the thermoform package or seal has been damaged. The natrelle inspira round gel implants are our roundest, fullest and most natural feeling products.
Women who underwent primary augmentation, revisionaugmentation, primary reconstruction, or revisionreconstruction were invited to participate. To report a problem with natrelle breast implants, please call allergan at 18004338871. Reconstruction acknowledgement of informed decision. Natrelle silicone gelfilled breast implants are available worldwide in a range of implant options. Each natrelle sterile silicone filled breast implant sizer is supplied in a sealed, double primary package. Natrelle salinefilled breast implants are indicated for females for the following. Summary basis of decision sbd for natrelle siliconefilled breast implantssmooth shell with barrier and narelle tm silicone filled breast implants textured shell with barrier layer. Round implants with smooth styles 60 or 68 or textured style 168 surfaces and shaped implants with textured surfaces styles 163, 363, and 468 were eligible for implantation in the study. Key benefits of natrelle inspira breast implants include. Sterility of the implant is maintained only if the thermoform package, including the package seal, is intact. The confidenceplus warranty applies to all natrelle breast implants listed above, provided the product has been used. Natrelle breast implant for cosmetic breast surgery. Natrelle continuing medical education for calvin lee, md. The natrelle collection important information natrelle breast implants and tissue expanders are latex free.
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