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Natrelle® | Breast Implants - Allergan Aesthetics. Actual Natrelle INSPIRA® patients. Individual results may vary. The Natrelle ® INSPIRA® Collection offers the largest selection* of smooth breast implants, and is the #1 selected breast implant by leading U.S. physicians**.
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What types of breast implants can I get from Allergan?
Why are Allergan breast implants recalled?
Does Allergan have a clinical study on Natrelle ® 410 breast implants?
Natrelle ® Breast Implants are approved for the following: Breast augmentation for women at least 22 years old for silicone-filled implants and for women at least 18 years old for saline-filled implants.
Jul 25, 2019 · The pharmaceutical company Allergan has recalled all BioCell textured breast implants at the request of the US Food and Drug Administration (FDA) because they have been linked to a rare type of lymphoma.
Aug 25, 2023 · As the new-generation cohesive silicone gel implant from Allergan, Natrelle Inspira implants add natural-looking fullness and shape to flat chests or breasts that have lost volume from breastfeeding or aging. They can also help reconstruct breasts after a mastectomy or significant lumpectomy.
- Natrelle Inspira implants are the latest generation of smooth, round, silicone gel–filled breast implants from Allergan. These implants are FDA-app...
- ProsAs the new-generation cohesive silicone gel implant from Allergan, Natrelle Inspira implants add natural-looking fullness and shape to flat che...
- Your price will depend on several factors, including the type of Inspira implants you choose, your surgeon’s level of experience, their practice lo...
- The outer shells of Natrelle Inspira implants used to be available in both smooth and textured surfaces, but now they are available only with smoot...
- The Inspira breast implant photos in our gallery have been shared by the provider who performed the procedure, with the patient's consent.
- Smooth surface implants
- Directions to the Physician
- Patient Counseling and Informed Decision Information
- Certification
- Device Tracking
- DEVICE DESCRIPTION
- INDICATIONS
- CONTRAINDICATIONS
- AVOID DAMAGE DURING SURGERY
- Specific Populations
- Important Factors to Convey to Patients
- Radiation to the Breast
- Breast Examination Techniques
- Screening Mammography
- Avoiding Damage During Treatment
- Mental Health and Elective Surgery
- POSSIBLE ADVERSE EVENTS
- Capsular Contracture
- Reoperation
- Implant Removal
- Lactation
- Pain
- Changes in Nipple and Breast Sensation
- Unsatisfactory Results
- Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
- Additional Complications
- OTHER REPORTED CONDITIONS
- Detection of Breast Implant Rupture
- ALLERGAN’S POST-APPROVAL STUDIES
- INSTRUCTIONS FOR USE
- Planning & Preparation
- Examination of Silicone Gel-Filled Breast Implants
- Sterile Product
- How to Open Sterile Product Package
- Device Implantation and Explantation Considerations
- Surgical Placement
- DOCUMENTATION THE PHYSICIAN SHOULD PROVIDE TO THE PATIENT
- GRAPHICAL SYMBOLS
WARNING: Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery. Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lympho...
The information supplied in this Directions for Use document is intended to provide physicians an overview of essential information about NATRELLE ® Silicone-Filled Breast Implants and NATRELLE INSPIRA® Breast Implants, including the indications for use, contraindications, warnings, precautions, important factors for a patient to consider, adverse...
You should review this document prior to counseling the patient about breast implant surgery with NATRELLE ® Silicone-Filled Breast Implants or NATRELLE INSPIRA® Breast Implants. Please familiarize yourself with the content of this document and resolve any questions or concerns prior to proceeding with use of the device. As with any surgical proce...
Certification via Allergan’s Physician Certification Program specific to NATRELLE ® Silicone-Filled Breast Implants is required in order to gain access to these implants. Please see the section “Preoperative Education, Planning, and Preparation” in the Instructions for Use, visit www.allerganacademy.com, or contact your local Hospital or Surgical ...
NATRELLE ® Silicone-Filled Breast Implants and NATRELLE INSPIRA® Breast Implants are subject to Device Tracking per federal regulation. This means that the physician is required to report to Allergan the serial number of the implanted device(s), the date of surgery, information relating to the physician’s practice, and information on the patient r...
NATRELLE ® Silicone-Filled Breast Implants and NATRELLE INSPIRA® Breast Implants are constructed with barrier shell technology resulting in a low diffusion silicone elastomer shell and are filled with silicone gel. All styles are single “lumen” round design and consist of a shell, a patch, and silicone gel fill. Allergan has approval for 3 types o...
NATRELLE ® Silicone-Filled Breast Implants and NATRELLE INSPIRA® Breast Implants are indicated for women for the following: Breast augmentation for women at least 22 years old. 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 augme...
Breast implant surgery should not be performed in: Women with active infection anywhere in their body Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions Women who are currently pregnant or nursing WARNINGS There is a boxed warning on all breast implants. Please see the cover page.
Care should be taken to avoid the use of excessive force and to minimize handling of the implant during surgical insertion. Data accumulated from Allergan’s retrieval study analyses of explanted ruptured silicone gel-filled breast implants, observations of surgeries, and a review of the published literature indicate that the forcing of implants thr...
Safety and effectiveness have not been established in patients with the following: Autoimmune diseases (e.g., lupus and scleroderma) A compromised immune system (for example, currently receiving immunosuppressive therapy) Planned chemotherapy following breast implant placement Planned radiation therapy to the breast following breast implant placeme...
Below are some of the important factors (Table 5), possible adverse events (Table 6), and other conditions (Table 7) your patients need to be aware of when considering NATRELLE ® Silicone-Filled Breast Implants or NATRELLE INSPIRA® Breast Implants. The patient labeling provides additional information on important factors for patients. Table 5: Imp...
• Allergan has not tested the effects of radiation therapy in patients who have breast implants. The literature suggests that radiation therapy may increase the likelihood of capsular contracture, necrosis, and implant extrusion
Patients should perform breast self-examinations monthly and be shown how to distinguish the implant from their breast tissue The patient should not manipulate or squeeze the implant excessively The patient should be told that the presence of lumps, persistent pain, swelling, hardening, or change in the implant shape may be signs of symptomatic rup...
Presurgical mammography with a follow-up mammogram after implantation may be performed to establish a baseline for routine future mammography in augmentation patients Patients should be instructed to undergo routine mammography exams as per their primary care physician’s recommendations. The importance of having these exams should be emphasized. Th...
• Patients should inform other treating physicians of the presence of implants to minimize the risk of damage to the implants
• It is important that all patients seeking to undergo elective surgery have realistic expectations that focus on improvement rather than perfection. Request that your patient openly discuss with you, prior to surgery any history that she may have of depression or other mental health disorders.
Potential adverse events that may occur with silicone gel-filled breast implant surgery include: implant rupture, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, he...
Patients should be advised that capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time Capsular contracture occurs more commonly in revision patients than in primary augmentation or reconstruction patients Capsular contracture is also a risk factor for implant rupture...
Patients should be advised that additional surgery to their breast and/or implant will likely be necessary over the course of their lives. Additional surgeries to the patients’ breasts will likely be required, either because of implant rupture, other complications, or unacceptable cosmetic outcomes. Patients may decide to change the size or type of...
Implants are not considered lifetime devices, and patients likely will undergo implant removal(s), with or without replacement, over the course of their lives When implants are explanted without replacement, changes to the patient’s breasts may be irreversible
Breast implant surgery may interfere with the ability to successfully breastfeed, either by reducing or eliminating milk production Breastfeeding difficulties have been reported following breast surgery, including breast reduction and breast augmentation A periareolar surgical approach may further increase the chance of breastfeeding difficulties
Pain of varying intensity and length of time may occur and persist following breast implant surgery In addition, improper size, placement, surgical technique, or capsular contracture may result in pain Patients should be advised to contact their surgeon if there is significant pain or if pain persists
Sensation in the nipple and breast can increase or decrease after implant surgery, is typically lost after complete mastectomy where the nipple itself is removed, and can be severely lessened by partial mastectomy Radiation therapy also can significantly reduce sensation in the remaining portions of the breast or chest wall The placement of breast ...
Patients should be informed that dissatisfaction with cosmetic results related to such things as scar deformity, hypertrophic scarring, capsular contracture, asymmetry, wrinkling, implant displacement/migration, incorrect size, and implant palpability/visibility may occur Careful surgical planning and technique can minimize, but not preclude, the r...
Based on information reported to global regulatory agencies and found in medical literature, an association has been identified between breast implants and the development of anaplastic large cell lymphoma (ALCL), a type of non-Hodgkin’s lymphoma. Women with breast implants may have a very small but increased risk of developing Breast Implant Assoc...
After breast implant surgery the following may occur and/or persist, with varying intensity and/or for a varying length of time: hematoma/seroma, implant extrusion, necrosis, delayed wound healing, and breast tissue atrophy/chest wall deformity Calcium deposits can form in the tissue capsule surrounding the implant with symptoms that may include pa...
The following symbols appear in the package labels for NATRELLE ® Silicone-Filled Breast Implants, NATRELLE INSPIRA® Responsive Breast Implants, NATRELLE INSPIRA® SoftTouch Silicone-Filled Breast Implants, and NATRELLE INSPIRA® Cohesive Silicone-Filled Breast Implants.
The following symbols appear in the package labels for NATRELLE ® Silicone-Filled Breast Implants, NATRELLE INSPIRA® Responsive Breast Implants, NATRELLE INSPIRA® SoftTouch Silicone-Filled Breast Implants, and NATRELLE INSPIRA® Cohesive Silicone-Filled Breast Implants.
The following symbols appear in the package labels for NATRELLE ® Silicone-Filled Breast Implants, NATRELLE INSPIRA® Responsive Breast Implants, NATRELLE INSPIRA® SoftTouch Silicone-Filled Breast Implants, and NATRELLE INSPIRA® Cohesive Silicone-Filled Breast Implants.
The following symbols appear in the package labels for NATRELLE ® Silicone-Filled Breast Implants, NATRELLE INSPIRA® Responsive Breast Implants, NATRELLE INSPIRA® SoftTouch Silicone-Filled Breast Implants, and NATRELLE INSPIRA® Cohesive Silicone-Filled Breast Implants.
The following symbols appear in the package labels for NATRELLE ® Silicone-Filled Breast Implants, NATRELLE INSPIRA® Responsive Breast Implants, NATRELLE INSPIRA® SoftTouch Silicone-Filled Breast Implants, and NATRELLE INSPIRA® Cohesive Silicone-Filled Breast Implants.
The following symbols appear in the package labels for NATRELLE ® Silicone-Filled Breast Implants, NATRELLE INSPIRA® Responsive Breast Implants, NATRELLE INSPIRA® SoftTouch Silicone-Filled Breast Implants, and NATRELLE INSPIRA® Cohesive Silicone-Filled Breast Implants.
The following symbols appear in the package labels for NATRELLE ® Silicone-Filled Breast Implants, NATRELLE INSPIRA® Responsive Breast Implants, NATRELLE INSPIRA® SoftTouch Silicone-Filled Breast Implants, and NATRELLE INSPIRA® Cohesive Silicone-Filled Breast Implants.
The following symbols appear in the package labels for NATRELLE ® Silicone-Filled Breast Implants, NATRELLE INSPIRA® Responsive Breast Implants, NATRELLE INSPIRA® SoftTouch Silicone-Filled Breast Implants, and NATRELLE INSPIRA® Cohesive Silicone-Filled Breast Implants.
The following symbols appear in the package labels for NATRELLE ® Silicone-Filled Breast Implants, NATRELLE INSPIRA® Responsive Breast Implants, NATRELLE INSPIRA® SoftTouch Silicone-Filled Breast Implants, and NATRELLE INSPIRA® Cohesive Silicone-Filled Breast Implants.
The following symbols appear in the package labels for NATRELLE ® Silicone-Filled Breast Implants, NATRELLE INSPIRA® Responsive Breast Implants, NATRELLE INSPIRA® SoftTouch Silicone-Filled Breast Implants, and NATRELLE INSPIRA® Cohesive Silicone-Filled Breast Implants.
The following symbols appear in the package labels for NATRELLE ® Silicone-Filled Breast Implants, NATRELLE INSPIRA® Responsive Breast Implants, NATRELLE INSPIRA® SoftTouch Silicone-Filled Breast Implants, and NATRELLE INSPIRA® Cohesive Silicone-Filled Breast Implants.
The following symbols appear in the package labels for NATRELLE ® Silicone-Filled Breast Implants, NATRELLE INSPIRA® Responsive Breast Implants, NATRELLE INSPIRA® SoftTouch Silicone-Filled Breast Implants, and NATRELLE INSPIRA® Cohesive Silicone-Filled Breast Implants.
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NATRELLE ® 410 Breast Implant. Who may get . NATRELLE ® 410 Breast Implants (INDICATIONS)? reast Implants have been approved for women for the . gery to correct or imp. rauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision sur.
Aug 2, 2019 · In a recent follow-up statement, Allergan announced the creation of the BIOCELL Replacement Warranty for all patients who currently have BIOCELL textured breast implants.
