The fda requests allergan voluntarily recall natrelle biocell textured breast implants and tissue expanders from the market to protect patients. Natrelle siliconefilled breast implants are indicated for females for the following. All implants they produce are fda approved, and thus have been rigorously tested and found to be safe. Only clinical studies with 10 year data were considered. The fda advises women with biaalcl to have their implants. Natrelle salinefilled breast implants smooth and biocell. This is the softest gel and has been preferred by millions of women worldwide. Natrelle breast implant sizes and specifications for all silicone and saline breast implants. A primary objective of bifs001 is to compare the longterm safety of natrelle silicone breast implants with that of saline implants. Truform 1 gel breast implants, and memorygel breast implants. All natrelle saline breast implants that have been implanted in the united states on or after june 1, 2009.
Fda summary of safety and effectiveness data page 2 women who are currently pregnant or nursing iv. Allergan requests the return of all explanted breast implants associated with a complaint to assist with evaluating and maintaining the quality and safety of natrelle breast implants. Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or imp rov e th sul f ab gn y. Warranty info for allergan breast implants natrelle. The fda requested that allergan recall all biocell textured breast implants and tissue expanders marketed in the u. Allergan natrelle silicone gel breast implant specifications allergan natrelle cohesive silicone gel implant specifications allergan natrelle saline breast implant specifications allergan natrelle breast implant warranty allergan natrelle breast implant warranty lifetime product replacement automatically applies to all recipients of certain natrelle style saline and silicone. Natrelle breast implants are approved for women for the following.
Both saline and silicone gel filled textured implants are covered. Mentor, natrelle or sientra silicone allergan natrelle, mentor, and sientra are the big three in terms of breast implant companies in the united states. A large, multicenter, 10year observational study is comparing the longterm safety and effectiveness of natrelle silicone breast implants versus saline implants or national norms. Natrelle breast implants, manufactured by allergan, are fdaapproved for breast augmentation and breast reconstruction. The fda requests allergan voluntarily recall natrelle biocell. Where applicable, financial assistance will be issued upon. Food and drug administration in 2006 based on interim results from the core study. Products are available textured and smooth moderate plus, xtra moderate plus, high, xtra high and ultra high projection gel breast implants as well as the mentor becker expanderbreast implants. Federal usa law restricts this device to sale by or on the order of a licensed physician dfu.
Natrelle siliconefilled breast implants and natrelle inspira breast implants are indicated for women for the following. The natrelle collection offers over 300 product options of breast implants and tissue expanders, tailored to all body types. Natrelle product catalogue pages 1 50 text version. Emily actual natrelle inspira primary augmentation patient. The natrelle style 410 shaped, formstable silicone gel implant allergan, inc. This brochure is not intended to replace consultation with your surgeon. For this brochure, it refers to placement of a breast implant. All natrelle implants are constructed of a silicone elastomer shell and are latex free.
However, women who choose to receive silicone versus saline breast implants may potentially differ in clinically important ways that can affect safety outcomes. Irvine, california has been the subject of a pivotal study. Breast augmentation for women at least 18 years old for salinefilled implants. Customers are instructed to contact genco pharmaceutical services if the recall actions on the recall letter are unclear. Allergan natrelle breast implant lawsuit filed over alcl. Breast augmentation for women at least 18 years old for saline filled implants. The natrelle silicone and saline breast implants are indicated for females for breast augmentation and breast reconstruction. Ultimately, your surgeon will help you determine what kind of implant best fits your body, and your goals for your surgery. They vary in material, size, and profile or projection.
Breast augmentation includes primary breast augmentation to increase breast. Natrelle silicone gelfilled breast implants allergan, irvine, calif. Mdc0177 %20r2%20hschsc%2b%20breast%20implants%20product%20catalog. Featuring our highest volume fill for a fuller upper pole and truform gel that is firm and offers the softest feel.
Considering silicone gelfilled breast implant surgery 11 1. Breast augmentation for women at least 22 years old. Natrelle breast implants are indicated for women for the following. B reconstruction includes primary reconstruction to replace breast. March 2006 inamed became allergan date of approval. Allergan has prepared this information to help you better understand the breast implant procedure and assist you in making an informed decision about breast.
Jul 31, 2018 furthermore, there are surgeons who agree that silicone implants have the most natural look and feel. Natrelle gelfilled breast implants are prefilled with cohesive silicone gel designed to simulate natural breast tissue. The confidenceplus warranty applies to all natrelle breast implants listed above, provided the product has been used. 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. Irvine, california has been the subject of a pivotal study that supports. The natrelle inspira round gel implants are our roundest, fullest and most natural feeling products. Warnings and precautions the warnings and precautions can be found in the natrelle 410 highly cohesive anatomically shaped siliconefilled breast implants labeling. The letter provides the problem identified and the action to be taken.
Natrelle gelfilled breast implants are designed for use in augmentation and reconstruction mammoplasty. Please note that natrelle smooth breast implants are not subject to this withdrawal. Allergan breast implant class action lawsuit over cancer. Pdf natrelle silicone breast implant followup study. 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. Cogel gummy bear implants are anatomicallyshaped with the nagotex microtextured surface. Mdc0177%20r2%20hschsc%2b%20breast%20implants%20product%20catalog. Textured breast implants are being recalled over a link to. Actual natrelle inspira breast reconstruction patient. Jan 10, 2019 according to allegations raised in a recent investor class action lawsuit, allergan falsely inflated the companys value by failing to disclose that certain types of breast implants may increase the r. May 17, 2018 the complaint pdf was filed last week in new jersey superior court, but michele rea and her husband, carl, indicating that allergan concealed the potential alcl cancer risk with natrelle breast. Allerganinamed natrelle siliconefilled breast implants. Natrelle style 410 formstable silicone breast implants oxford.
Recipients of natrelle style breast implants are already protected against rupture or deflation with allergans confidenceplus warranty program. Breast augmentation for women at least 22 years old for siliconefilled implants. Allergan has prepared this brochure to provide you with a high level overview of the facts about breast implant surgery with allergans fdaapproved. Natrelle siliconefilled breast implants p020056 are the. Jul 27, 2019 if youre one of the hundreds of thousands of people who have the textured implants, you might be understandably concerned. Breast augmentation is one of the most common cosmetic surgical procedures performed in the united states. Allergans natrelle round siliconefilled breast implants were approved by the u. Allergan natrelle collection breast implants warranty. Jan 01, 2009 fda approval was granted in 2000, and the devices branded as natrelle salinefilled breast implants are currently in widespread use in the united states. Breast augmentation with natrelle siliconefilled breast. A recall letter dated 6815 was sent to all customers who received the natrelle 410 cc resterilizable breast implant sizer.
Allergan recalls natrelle biocell textured breast implants. 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. Large bodies of data now support the safety of breast implants in general, with the main safety concerns being the potential for local complications and the need for secondary surgeries. Apr 01, 2019 all natrelle gel breast implants that have been implanted in the united states between june 1, 2009 and december 31, 2009. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or. The natrelle 410 resterilizable breast implant sizers are constructed from a smooth silicone shell and are filled with a gel that maintains the shape. Natrelle siliconefilled breast implants and natrelle inspira breast implants. 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. The standard cohesive level gel used in mentor breast implants.
Natrelle resterilizable breast implant sizers are supplied sterile and intended for a maximum of ten additional reuses following cleaning, disinfection. Allergan breast implant recalls list of affected models. Pdf the natrelle style 410 shaped, formstable silicone gel implant allergan, inc. Natrelle saline and silicone breast implant sizes, specs. Pdf natrelle style 410 formstable silicone breast implants.
The fda requests allergan voluntarily recall natrelle. Your complete guide to nagor implants breast augmentation. By clicking accept you understand that you are directing. Breast reconstruction with natrelle siliconefilled breast. Breast augmentation for women at least 22 years old for silicone filled implants. These core clinical studies did not include natrelle inspira round truform 1 gel breast implants, natrelle 410 truform 2 gel breast implants, or natrelle 510 dual gel anatomical breast implants. The natrelle 410 and round resterilizable sizers have been designed to match the natrelle style 410 breast implants and the natrelle round silicone breast implants, respectively. Most of allergans recalled textured breast implants were sold under the natrelle brand. In july 2019, allergan recalled its biocell textured breast implants after the fda had linked them to a rare cancer called breast implantassociated anaplastic large cell lymphoma, or biaalcl. Planned radiation therapy to the breast following breast implant placement. Breast implants are not lifetime devices, and not necessarily a onetime surgery, allergan wrote in its breast augmentation with natrelle siliconefilled breast implants and natrelle inspira breast implants brochure. Evolution and update on current devices for prosthetic breast reconstruction. Read more on the pros and cons of silicone breast implants.
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