Customers are instructed to contact genco pharmaceutical services if the recall actions on the recall letter are unclear. According to allergan, the company behind it, the latest option called natrelle inspira cohesive combines a high gelfill ratio. An arizona woman has filed a product liability lawsuit against allergan, alleging that she suffered a number of complications from the companys. Breast augmentation for women at least 18 years old for salinefilled implants. 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. Natrelle410 breast implants are anatomically shaped and. Bengtson, a plastic surgeon in grand rapids, mi, holds the largest single surgeon augmentation patient series of natrelle highly cohesive gel breast gummy bear implants in the u. May 10th, 2000 mcghan salinefilled breast implant recalls. Table of contents indications and important safety information 2 natrellethe 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. Examination showed that her left breast was smaller. Revis is pleased to offer allergan natrelle silicone gel and saline breast implants as options to his breast augmentation patients. A recall letter dated 6815 was sent to all customers who received the natrelle 410 cc resterilizable breast implant sizer.
Natrelle breast implants, manufactured by allergan, are fdaapproved for breast augmentation and breast reconstruction. Breast augmentation can be lifechanging if you have always felt selfconscious about your breast size. I have not had a chance to examine these implants, but my gut feeling says the very firm one is similar to the gummy bear implant natrelle style 410 anatomical shaped implant. New fdaapproved inspira designed for increased fullness. Breast augmentation is one of the most common aesthetic operations. Available in both saline and silicone, natrelle breast implants are used in breast augmentation as well as breast reconstruction surgery.
Natrelle has been used for over 25 years and is available as a mode of breast augmentation, revision, and reconstructive surgery for women in over 60 countries. Your plastic surgeon is best decision for you its your body and you deserve all the facts about getting breast implants. Whether you are seeking breast augmentation for the first time or. Oct 03, 2016 last week, the fda gave the green light to new breast implants. As a board certified plastic surgeon and have the answered sent to. Breast augmentation for women at least 18 years old for saline filled implants. Reconstruction acknowledgement of informed decision. Allergan manufactures the natrelle line of saline and silicone breast implants, and the more recently fdaapproved inspira line. Natrelle breast implants allergan natrelle, mentor, and sientra are the big three in terms of breast implant companies in the united states. 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. Natrelle continuing medical education for calvin lee, md. Breast surgery with natrelle salinefilled breast implants, is designed to provide you with an.
We can help you achieve that result with breast implants in san francisco. Breast augmentation for women at least 22 years old for silicone filled implants. Primary breast augmentation the first time a breast implant is placed for the purpose of breast augmentation. 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. Agn, headquartered in dublin, ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Natrelle breast implant for cosmetic breast surgery. The initial 3year and subsequent 6year clinical data on these implants from an investigational device exemption study initiated in february 2001 have been published previously. Allergan began manufacturing and distributing natrelle implants soon after the fda silicone ban was lifted in 2006. Core study results at 10 years article pdf available in plastic and reconstructive surgery 36. Its hard to miss the display of natrelle breast implants in the waiting room when you arrive at cape and islands plastic surgery many patients and their friends are drawn to this display. Natrelle breast implants look and feel natural, maintain their shape over time, and are offered in a full range of sizes to help you achieve your desired fullness. Linders blog 3 months postop using natrelle inspira scx implants. Jun 14, 20 natrelle a complete line of breast implants from allergan.
Natrelle breast implants are approved for women for the following. Breast augmentation for women at least 18 years old. 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. Sep 25, 2015 the natrelle 410 breast implant allergan, inc. With over 140 different implant styles and shapes, the natrelle collection truly provides personalized breast augmentation or enhancement. Newsstatistics20162016plasticsurgerystatisticsreport. The following are warnings associated with natrelle siliconefilled breast implants and natrelle inspira breast implants. We now have so many choices regarding breast implant options, it is almost like going to a supermarket and trying to pick one cereal over the other.
All implants they produce are fda approved, and thus have been rigorously tested and found to be safe. When you choose natrelle gel implants for your breast augmentation, you. Revisionaugmentation refers to the correction or improvement of a primary augmentation. 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. Natrelle salinefilled breast implants directions for use. The natrelle inspira round gel implants are our roundest, fullest and most natural feeling products. Tenyear results from the natrelle 410 anatomical form. Additional notes regarding the natrelle style 410 breast implants. Breast reconstruction a surgical procedure to replace breast tissue or reconstruct a breast after tissue was taken out because of cancer or injury. We now have so many choices regarding breast implant options, it is almost like going to a.
Dec 10, 2012 an arizona woman has filed a product liability lawsuit against allergan, alleging that she suffered a number of complications from the companys natrelle silicone breast implants, including neurologic. Relative contraindications for 410 natrelle breast implants. Reoperation an additional surgery after your first breast implantation. 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. Style 10, 15, 20, 110, 115, 120, 410, inspira this is a limited warranty only and is subject to the terms and conditions set forth in. They enjoy the ability to examine actual samples of both salinefilled and silicone gelfilled breast implants while they wait to consult with dr. The letter provides the problem identified and the action to be taken. For similar base width, choose from moderate, midrange and high profile designs. There has been a steady increase in breast augmentation surgery with. 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.
Featuring our highest volume fill for a fuller upper pole and truform gel that is firm and offers the softest feel truform cohesive gel provides desired firmness. Breast augmentation with natrelle siliconefilled breast. Shaping the future with you only natrelle does gummy. Depending who you speak to, all other gummy bear implants are either an. The implant may vary in shape, profile, volume, shell surface, and shell thickness.
Even metaanalysis research combining data from over 87,000. Apr 01, 2019 for patients choosing natrelle saline breast implants, enrollment in the confidenceplus premier warranty must be submitted within 45 calendar days of surgery. Evolution and update on current devices for prosthetic breast reconstruction. For patients choosing natrelle saline breast implants, enrollment in the confidenceplus premier warranty must be submitted within 45 calendar days of surgery. I am choosing to proceed with salinefilled breast implant surgery. Natrelle breast implants are indicated for women for the following. Implant and the allergan natrelle 410 breast implant core studies. Natrelle salinefilled breast implants are indicated for females for the following. To report a problem with natrelle breast implants, please call allergan at 18004338871. Shaping the future with you san francisco plastic surgery. Werecommitted to giving you the results you desire with natrelle gel breast implantsalong with a complimentary allergan facial treatment for you and a friend.
Breast implants are not lifetime devices, and breast implantation is not necessarily a onetime surgery. In 2011 the fda identified the possible association between breast implants and the development of anapestic large cell lymphoma alcl. Feb 23, 2015 the initial 3year and subsequent 6year clinical data on these implants from an investigational device exemption study initiated in february 2001 have been published previously. Actual natrelle inspira breast reconstruction patient. Mentor silicone gelfilled breast implants around the world. Natrelle inspira breast implants are indicated for women for the following. Natrelle highly cohesive gel breast implant available for interviews. For information on biocell textured implants and tissue expanders, please click here. 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.
Longterm safety of textured and smooth breast implants. Silicone breast implant lawsuit filed over problems with. Depending who you speak to, all other gummy bear implants are either an imitation of the natrelle 410, or an improvement. Natrelle and natrelle inspira siliconefilled breast implants. In 2011 the fda identified the possible association between breast implants and. All designed to help you find the fit thats right for you. There are many exciting new types of implants available today, including anatomical teardrop shaped and cohesive silicone gel. For the complete list of questions, download the full pdf. Breast augmentation for women at least 22 years old for siliconefilled implants.
Mar 29, 2018 silicone gelfilled breast implant a sterile implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxanes, with a single lumen filled with a fixed amount of silicone gel. Considering silicone gelfilled breast implant surgery 11. Factors such as pregnancy when milk glands are temporarily enlarged, rapid weight loss, and the effects of gravity as you age combine to stretch the skin, which. The following information answers many common questions possibly your partner throughout your augmentation or reconstruction. The new natrelle inspira cohesive line of breast implants is the newest entry into the category of breast implants commonly referred to as gummy implants, designed for women who are. Allergan announces fda approval of natrelle inspira. The allergan natrelle 410 breast implant was approved for sale in the united states in february 20. As more and more women decide upon breast augmentation, breast enhancement surgery, or plastic surgery, it is reassuring to know that implants in the natrelle collection are safe.
It can reinvigorate your confidence and selfesteem. You may be considering breast implant surgery to restore your breast shape after a mastectomy or an injury that resulted in either partial or total loss of your breast s or to correct a birth defect. Natrelle a complete line of breast implants from allergan. Sientra texture is described as a blend of the micro and. 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. Natrelle siliconefilled breast implants and natrelle inspira breast implants. Breast implantassociated anaplastic large cell lymphoma biaalcl is a cancer of the immune system caused by breast implants and predominately linked with textured implants. Qualified allergan breast implants are the following hereinafter referred to as allergan breast implants. Natrelle is arguably the most popular line of breast implants used in the u. You will likely need additional surgeries on your breasts due to complications or unacceptable cosmetic results. Last week, the fda gave the green light to new breast implants. Breast augmentation with natrelle siliconefilled breast implants aug patient labeling rev 4609 page 1. Allergan natrelle breast implants south florida plastic.
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