A recall letter dated 6815 was sent to all customers who received the natrelle 410 cc resterilizable breast implant sizer. Class action lawsuit alleges recalled allergan biocell. As a board certified plastic surgeon and have the answered sent to. Six month postoperative photographs show the results following a bilateral dual planeone, subpectoral breast augmentation with natrelle style 20 high profile, smooth, round silicone gelfilled breast implants placed via an inframammary incision. Ultimately, your surgeon will help you determine what kind of implant best fits your body, and your goals for your surgery. Natrelle silicone gelfilled breast implants are available worldwide in a range of implant.
Breast reconstruction a surgical procedure to replace breast tissue or reconstruct a breast after tissue was taken out because of cancer or injury. In 2012, an arizona woman filed a lawsuit pdf against allergan, alleging that she suffered a number of complications from natrelle silicone breast implants, including neurological problems and vision loss. Natrelle silicone gelfilled breast implants allergan, irvine, calif. Mentor memorygel silicone breast implant lawsuits started in october 2016 with ebrahimi v. Customers are instructed to contact genco pharmaceutical services if the recall actions on the recall letter are unclear. 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. Warranty info for allergan breast implants natrelle. Study baseline data and surgical characteristics are reported here. Mdc0177%20r2%20hschsc%2b%20breast%20implants%20product%20catalog. A large, multicenter, 10year observational study is being conducted to compare the longterm safety and effectiveness of natrelle silicone breast implants with saline implants or national norms.
Women seeking primary augmentation, revisionaugmentation, primary reconstruction, or revisionreconstruction. The kit includes implants, a sizing bra and educational products that will help you try out your ideal look in a scientific manner and with a great degree. Natrelle and natrelle inspira siliconefilled breast implants. Breast implant lawsuit breast implant complications lawyer. Allergan announces fda approval of natrelle inspira. Allergan natrelle salinefilled breast implants formerly mcghan rtv salinefilled mammary implant approved under p990074. Natrelle 3s smooth tissue expanders important information approved uses natrelle 3s. Natrelle breast implants are available by prescription only.
The lawsuit says the warranty, which is to run until july 24, 2021 and apply only to revision surgeries done on or after july 24, 2019, provides that allergan will replace patients biocell textured. Mentor, passed preemption twice, first in january and then in june 2018. Breast augmentation is one of the most common cosmetic surgical procedures. Breast augmentation for women at least 18 years old. Briefly, subjects were implanted with natrelle round siliconefilled breast implants. Depending who you speak to, all other gummy bear implants are either an. Breast augmentation with natrelle siliconefilled breast. Results for prospective breast augmentation patients. Six days after the fda recalled allergans biocell textured breast implants, the company announced the creation of a replacement warranty for all patients who currently had the product. A primary objective of bifs001 is to compare the longterm safety of natrelle silicone breast implants with that of saline implants. The confidenceplus warranty applies to all natrelle breast implants listed above, provided the product has been used. Evolution and update on current devices for prosthetic breast reconstruction. Allerganinamed natrelle siliconefilled 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. The third quarter 2019 results demonstrate our commitment to. Actual natrelle inspira breast reconstruction patient. The fda has evaluated and approved natrelle silicone gelfilled breast implants for breast augmentation and breast reconstruction based on years of data collected from more than 50,000 women.
Assessment of shaped implants from allergan and sientra. Allergan has prepared this brochure to provide you with a high level overview of the facts about breast implant surgery with allergans fdaapproved. The detailed study design and inclusionexclusion criteria were published in the 2007 article along with the 6year results. They vary in material, size, and profile or projection. 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. How to find out what type of breast implant you have. Weber alleges that the allergan natrelle silicone breast implants were defectively designed and also claims that she was unwittingly enrolled in a. For the complete list of questions, download the full pdf. A mentor memorygel silicone breast implant case, gravitt et al v. Allergan breast implant class action lawsuit over cancer. All designed to help you find the fit thats right for you. So far, the majority of reported cases worldwide involved allergans textured implants, according to the fda. Pdf natrelle silicone breast implant followup study.
The fda requests allergan voluntarily recall natrelle. 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. 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.
Core study results at 10 years article pdf available in plastic and reconstructive surgery 36. Breast augmentation for women at least 22 years old. Natrelle salinefilled breast implants are indicated for women at least 18 years old. Silicone breast implant lawsuit filed over problems with. The main injury claimed in allergan breast implant lawsuits is a rare type of cancer called breast implantassociated anaplastic large cell lymphoma, or biaalcl. Natrelle breast implants, manufactured by allergan, are fdaapproved for breast augmentation and breast reconstruction. All implants they produce are fda approved, and thus have been rigorously tested and found to be safe. Shaping the future with you only natrelle does gummy. Lawsuits scroll down for a current list of breast implant lawsuits. However, women who choose to receive silicone versus saline breast implants may potentially differ in clinically important ways that can affect safety outcomes. Natrelle siliconefilled breast implants and natrelle inspira breast implants. Breast augmentation includes primary breast augmentation to increase breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.
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. Natrelle breast implants 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. Both of the women were forced to pay outofpocket for surgery to remove and replace their recalled implants.
Natrelle salinefilled breast implants directions for use. Plaintiff received the implants in 2009 and was subsequently required to undergo a bilateral mastectomy due to breast cancer. Allergan breast implant lawsuit potential links to biaalcl. The letter provides the problem identified and the action to be taken. Cancer victims file breast implant class action in california in august 2019, two women who were diagnosed with cancer filed a class action pdf against allergan in california. To report a problem with natrelle breast implants, please call allergan at 18004338871. Examination showed that her left breast was smaller. Reconstruction acknowledgement of informed decision. Allergan is recalling its biocell textured breast implant products, including. For general questions about allergan, or to request additional information, please use the form below to contact us. Allergan nabs fda clearance of natrelle inspira softtouch. A silicone gelfilled breast implant is a sac implant shell of silicone elastomer rubber filled with silicone gel.
1620 504 1015 795 418 902 1432 599 232 1097 438 86 323 845 1350 1481 218 526 1463 1543 1219 529 809 134 756 3 549 1261 1264 67 965 903 219 531 130 304 1346 34 826 846 622