Any unauthorized or illegal use, copying or dissemination will be prosecuted. The REVOLVE System and REVOLVE ENVI 600 System are intended for use in the following surgeries when drawing fat is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, bone or muscle surgery, gynecological surgery, thoracic surgery, and minimally invasive surgery. Lumps, persistent pain, swelling, hardening, or changes in implant shape should be reported to your surgeon and possibly evaluated with imaging, Minimize strenuous exercise and exposure to extensive sun or heat within the first 24 hours following treatment. Tell your doctor if you have any medical conditions as CoolTone should not be used over a menstruating uterus, over areas of the skin that lack normal sensation, in patients with fever, malignant tumor, hemorrhagic conditions, epilepsy, recent surgical procedure, pulmonary insufficiency, or pregnancy. Caution should be used for patients with suspected or diagnosed heart problems. 5-star reviewed medical and legal information site. However, if your local IRB requires you submit for further review, please contact research@plasticsurgery.org to obtain the necessary documents that are required for your submission. Customer Contact [?] These are not all the possible side effects of LATISSE. Please call us using the phone number listed on this page. You should not be treated with CoolSculpting if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria. A healthcare provider will determine if Member is an appropriate candidate for a BOTOX Cosmetic or JUVDERM Ultra XC treatment. Breast Augmentation Breast Reconstruction For Consumers Loyalty Program All Find a Provider Search Consumer Product Questions Call 1 (800) 678-1605 Report a Side Effect or Adverse Event Call 1 (800) 678-1605 For Providers natrellesurgeon.com Provider Product Questions Call 1 (800) 678-1605 Do not use LATISSE if you are allergic to one of its ingredients. Natrelle Breast Implants IMPORTANT SAFETY INFORMATION AND APPROVED USES . The device will not, in and of itself, produce significant weight reduction. For more information, visit our partners page. McGhan RTV Saline-Filled Mammary Implants became Allergan Natrelle Saline-Filled Breast Implants, and Inamed Silicone-Filled Breast Implants became Allergan Natrelle Silicone-Filled Textured Breast Implants. Doctors diagnosed her with BIA-ALCL in 2017. Having a family member with major depression and anxiety, I was looking for information on her medications. Allergan Aesthetics, an AbbVie company, reserves the right to alter or cancel this offer at any time. BOTOX Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX Cosmetic. Please see bold text at beginning, Many changes to your breasts following implantation are irreversible. This means physicians can fulfill their device tracking requirements for Allergan, Mentor and Sientra by participating in the NBIR. Allergans smooth implants are not a part of the July 2019 recall. Breast implants are not considered lifetime devices. Please see full Important Safety Information for CoolSculpting on CoolSculpting.com. If you have eye problems/surgery, consult your doctor. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. CoolTone should be used with caution in patients with Graves disease (an autoimmune disorder that causes overactive thyroid), active bleeding disorders, or seizure disorders. What are key complications with breast implants? The safety of these products for use during pregnancy or while breastfeeding has not been studied, The safety of JUVDERM VOLUMA XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. Editors carefully fact-check all Drugwatch content for accuracy and quality. One of our content team members will be in touch with you soon. JUVDERM VOLBELLA XC and JUVDERM Ultra XC are intended for use in the lips and perioral area. To report a problem with Natrelle Breast Implants, please call Allergan at 1-800-624-4261. . https://www.fda.gov/medical-devices/safety-communications/breast-implants-reports-squamous-cell-carcinoma-and-various-lymphomas-capsule-around-implants-fda, https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma, https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue, https://www.tga.gov.au/alert/breast-implants-and-anaplastic-large-cell-lymphoma, https://www.allergan.com/-/media/allergan/documents/us/Products/Biocell/Affected-Products-List.pdf, https://www.statnews.com/2019/07/24/allergan-recalls-textured-breast-implant-tied-to-rare-cancer/, https://www.fiercebiotech.com/medtech/allergan-issues-worldwide-recall-textured-breast-implants-over-cancer-cases, https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan, https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl, https://www.icij.org/investigations/implant-files/australia-set-to-join-nations-banning-textured-breast-implants-over-cancer-links/, https://www.newswire.ca/news-releases/information-update-health-canada-suspends-allergan-s-licences-for-its-biocell-breast-implants-after-safety-review-concludes-an-increased-risk-of-cancer-880208806.html, https://www.reuters.com/article/us-allergan-canada/allergan-to-recall-textured-breast-implants-in-canada-idUSKCN1SY2BX, https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2019-5-10-bia-alcl-rush-complaint.pdf, https://www.fda.gov/news-events/press-announcements/statement-binita-ashar-md-fdas-center-devices-and-radiological-health-agencys-continuing-efforts, https://allergan-web-cdn-prod.azureedge.net/actavis/actavis/media/allerganinvestors/financial-information/proxy-materials/2018_10-k.pdf, https://www.medtechdive.com/news/allergan-loses-ce-mark-for-textured-breast-implants-opening-eu-market/544885/, https://news.abbvie.com/news/allergan-press-releases/allergan-suspends-sales-and-withdraws-supply-textured-breast-implants-in-european-markets.htm, https://www.allergan.com/-/media/allergan/documents/us/Investors/FAQs/FAQonCEMarkNonRenewalofTexturedBreastImplantsandTexturedTissueExpandersBreastImplantsInvestorFAQs.pdf, https://www.icij.org/investigations/implant-files/allergan-textured-breast-implants-recalled-in-europe-pending-safety-review/, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137978, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137741, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=137972, 163 BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants, Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants, 410 LL, 410 LM, 410 LF, 410 LX, 410 ML, 410 MM, 410 MF, 410 MX, 410 FL, 410 FM, 410 FF, 410 FX, Biocell Textured Round Gel-Filled Implants, 110, 115, 120 Moderate, Midrange and High Projection, Natrelle Inspira Biocell Textured Responsive Silicone-Filled Breast Implants, Natrelle Inspira Biocell Textured Cohesive Silicone-Filled Breast Implants, Natrelle Biocelle Textured Soft Touch Silicone-Filled Breast Implants, Natrelle 133 Tissue Expanders with suture tabs. Western Institutional Review Board has determined that the NBIR is not research and does not require IRB review. For JUVDERM VOLLURE XC, JUVDERM Ultra Plus XC, and JUVDERM Ultra XC injectable gels, most resolved within 14 days or less. Claims for Ocumend are based on traditional homeopathic practice, not accepted medical evidence. Retrieved from, U.S. Food and Drug Administration. TheNatrelle INSPIRA Collection offers the largest selection* of smooth breast implants, and is the #1 selected breast implant by leading U.S. physicians**. Other side effects of BOTOX Cosmetic include: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes. The recall was requested by the U.S. Food and Drug Administration (FDA) after the agency found that the implants have been linked to a form of cancer called breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). If you arent sure what model and style you have, contact your surgeon. Review our editorial policy to learn more about our process for producing accurate, current and balanced content. The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication. If you later choose to have your implants removed and not replaced, you may experience dimpling, puckering, wrinkling, or other cosmetic changes, which may be permanent, Breast implantation is likely not a one-time surgery. Not all Allergan breast implants have been linked to cancer. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin, The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse, JUVDERM VOLBELLA XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. Most cases of BIA-ALCL occur many years after receiving a textured implant, according to the FDA. Class 2 Device Recall Natrelle CUI Tissue Expander. BOTOX Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crows feet lines, and frown lines between the eyebrows in adults. 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 To report a side effect with any product in the JUVDERM Collection, please call the Allergan Product Support Department at 1-877-345-5372. Allergan. Breast implants have been associated with the development of a cancer of the immune system called breast implantassociated anaplastic large cell lymphoma (BIA-ALCL). Breast implants are not considered lifetime devices. Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. 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 BIA-ALCL. The information on this website is proprietary and protected. Phone: 8006244261 Email: ProductSupport@allergan.com CLOSE. Retrieved from, U.S. Food and Drug Administration. Your doctor may choose to treat side effects persisting over 30 days with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid). Please see LATISSE full Prescribing Information. JUVDERM VOLLURE XC, JUVDERM Ultra Plus XC, and JUVDERM Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Please scroll for BOTOX Important Safety Information including Boxed Warning, full Prescribing Information and Medication Guide. Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products. The restrictions on sale and distribution are included in the Post-Market Approval (PMA) Supplement Approval letter for these implants. Member must claim offer in the All app via text message link within 6 months of their. Allergan Textured Breast Implant Sales Halted in Europe Amid Safety Controversy. The Plastic Surgery Foundation has developed the National Breast Implant Registry (NBIR) in collaboration with the FDA, patients and breast implant manufacturers to strengthen the post-market surveillance infrastructure for current and future breast implant devices in the United States. Please wait a moment and try again. In order to sell its breast implants in 33 European countries, Allergan needs a safety certificate known as a CE mark. BOTOX Cosmetic (onabotulinumtoxinA) , JUVDERM Injectable Gel Fillers, KYBELLA (deoxycholic acid) injection 10 mg/mL , CoolSculpting Treatment, CoolTone Treatment, Natrelle Breast Implants including Boxed Warning, REVOLVE ADVANCED ADIPOSE SYSTEM, SkinMedica, LATISSE (bimatoprost ophthalmic solution) 0.03%. The value of this offer cannot be redeemed or exchanged for cash. What else should I know? When should REVOLVE System or REVOLVE ENVI 600 System NOT be used? (2018, December 31). I found information that was very helpful, that her psychiatrist never told her.". We only gather information from credible sources. All trademarks are the property of their respective owners. Only apply at base of upper lashes. Reason: Labeling error. This allows users to submit a case to the NBIR while registering a device with Allergan, Mentor and Sientra in a matter of minutes. To report a side effect, please call Allergan at. U.S. Food and Drug Administration. REVOLVE System and REVOLVE ENVI 600 System are for use only by a licensed physician. 2023 Drugwatch.com Privacy Policy / Advertising Disclosure / In July 2019, the FDA requested that Allergan recall its Biocell textured breast implants because they had been linked to BIA-ALCL, or breast implant-associated anaplastic large cell lymphoma, a rare cancer. Products in the JUVDERM Collection are available only by a licensed physician or properly licensed practitioner. Drugwatch.com is HONCode (Health On the Net Foundation) certified. Drugwatch.com has provided reliable, trusted information about medications, medical devices and general health since 2008. Some patients report complete resolution of symptoms when the implants are removed without replacement. The FDA has not released the exact number of implants affected. Of the 33 deaths, 12 patients had an Allergan breast implant at the time of their BIA-ALCL diagnosis, and one was from another company. TGA gave manufacturers until July 24, 2019, to respond. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental or submandibular area treatment. The .gov means its official.Federal government websites often end in .gov or .mil. For more information, see the patient brochures at www.allergan.com/products. Helped more than 12,000 people find legal help. You will likely need additional surgeries on your breasts due to complications or unacceptable cosmetic results. We have provided this information to help women make informed decisions about whether or not to get breast implants: The recommendations in this guidance supplement the recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued September 29, 2020, superseding the prior version dated November 17, 2006. There has not been a confirmed serious case of spread of toxin effect when BOTOX Cosmetic has been used at the recommended dose to treat frown lines, crows feet lines, and/or forehead lines. Your web browser is no longer supported by Microsoft. Textured shells allow tissue to grow into the surface of the implant and keep it in place. KYBELLA (DEOXYCHOLIC ACID) INJECTION 10 mg/mL, LATISSE (BIMATOPROST OPHTHALMIC SOLUTION) 0.03%, All Loyalty Program Terms and Conditions, Women with active infection anywhere in their body, Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions, Women who are currently pregnant or nursing, Autoimmune diseases (eg, lupus and scleroderma), A weakened immune system (eg, taking medications to decrease the bodys immune response), Planned chemotherapy or radiation therapy following breast implant placement, Conditions or medications that interfere with wound healing and blood clotting, Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders, Those with a diagnosis of depression or other mental health disorders should wait for resolution or stabilization of these conditions prior to undergoing breast implantation surgery, There is a Boxed Warning for breast implants. Drugwatch has a stringent fact-checking process. If you have symptoms of or uncertain ultrasound results for breast implant rupture, an MRI is recommended. Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as. Allergan Aesthetics, an AbbVie company, is providing these links to you only as a convenience. Can Allergan breast implants cause cancer? With five different profile options and three unique gummy gels,Natrelle gives you options to help you achieve your desired look whether thats minimal enhancement or maximum fullness. SkinMedica Total Defense + Repair Broad Spectrum Sunscreens (SPF 34, SPF 34 Tinted, and SPF 50+) and Essential Defense Broad Spectrum Sunscreens (Everyday Clear SPF 47, Mineral Shield Tinted SPF 32, and Mineral Shield SPF 35) are over-the-counter drug products which are formulated and marketed pursuant to FDAs governing regulations set forth at 21 C.F.R. Statement from Binita Ashar, M.D., of the FDAs Center for Devices and Radiological Health on agencys continuing efforts to educate patients on known risk of lymphoma from breast implants. These SkinMedica products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. Your doctor may choose to treat side effects persisting over 30 days with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid). b. Implanting/Explanting Physician Information Allergan released a list of all its recalled textured breast implant products sold across the globe. Though BIA-ALCL is a serious and potentially fatal disease, the risk of developing the cancer is low. It starts with our strict sourcing guidelines. For JUVDERM VOLUMA XC, most side effects resolved within 2 to 4 weeks. of the forms and place the device tracking label to page 2 of the forms, L for the left breast implant and R for the right breast implant. Allergan issued a worldwide recall on July 24, 2019, but other countries had already asked the company to stop selling its implants because of BIA-ALCL concerns. The disease is highly treatable, especially if diagnosed early. We need everyone who performs breast implant procedures to participate in this very important initiative. Do you wish to leave this site? Both types have a silicone outer shell. SkinMedica Pro-Infusion Serums are intended to meet the FDAs definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. Patients can access their ID card at any time through their app by tapping the Document Vault and selecting implants.Additional App FeaturesWhat does the breast implant scanner do? If labels are not available, please record the catalog number (REF) and serial number (SN) in the space provided for each page of the form. It is good to have the information but your surgeon can do the revision without it too. BOTOX Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX Cosmetic. FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market. The NBIR Device Tracking app is available for all Apple and Android mobile devices. On Aug. 2, 2019, Allergan announced it would recall the products from the Australian market. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device. 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: breast implant associated anaplastic large cell lymphoma (BIA-ALCL). JUVDERM Ultra XC injectable gel is for injection into the lips and perioral area for lip augmentation in adults over 21. For example, Sandra Rush a woman who filed an Allergan breast implant lawsuit received a McGhan textured saline implant in 1995. This includes peer-reviewed medical journals, reputable media outlets, government reports, court records and interviews with qualified experts. The longer implants are in place, the greater the potential risk for complications. This means that no one can sell Allergans Biocell breast implants in Canada or import them into the country.. The information on Drugwatch.com has been medically and legally reviewed by more than 30 expert contributors, including doctors, pharmacists, lawyers, patient advocates and other health care professionals. The company sent recall letters to customers. 2022 AbbVie. Device description with a list of specific materials in the device. Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Patients receiving breast implants have reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. (2019, August 2). Using BOTOX Cosmetic with certain other medicines may cause serious side effects. We are very excited to present the 2021 Annual Report of The Plastic Surgery Foundation's National Breast Implant Registry (NBIR). IMPORTANT: make sure the posted date is listed as "Sep 29, 2020" because there may be more than one document with this title listed there. Individual patient risk for developing these symptoms has not been well established. Sorry there is a continuing error in our system. Retrieved from, U.S. Food and Drug Administration. What Should I Do If My Implant Is Recalled? What should I discuss with my doctor before my procedure? Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc, Dysport, or Xeomin in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners. (2011, June). What is KYBELLA? Once claimed, the selected complimentary treatment cannot be changed and the offer must be redeemed within 6 months of the offer being deposited into Members All Wallet. Rare serious side effects may also occur and include severe skin irritation and allergic reactions. Perform self-examination every month for cancer screening and ask your surgeon to help you distinguish the implant from your breast tissue. To report a side effect, please call Allergan at 1-800-678-1605. Offer cannot be applied to past transactions. Other complications include breast pain, swelling, asymmetry, wrinkling/rippling, implant malposition nipple complications, hypertrophic scarring, and implant palpability/visibility. If you arent sure if your implant is on this list, make sure you check with your surgeon. This website and its content may be deemed attorney advertising. KYBELLA can cause serious side effects, including: The most common side effects of KYBELLA include swelling, pain, numbness, redness, and areas of hardness in the treatment area. CoolSculpting is FDA-cleared for the treatment of visible fat bulges in the submental (under the chin) and submandibular (under the jawline) areas, thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm. The 5,990 incidents were submitted in bulk by breast implant makers Allergan and Johnson & Johnson affiliate Mentor on three dates in 2019: Jan. 14, June 26 and Nov. 7, according to CBC's analysis . Talk to your doctor about other complications. Breast implants are medical devices implanted under the breast tissue or chest muscle to increase breast size (augmentation) or to replace breast tissue that has been removed due to. Now, NBIR Participants can choose from three different data entry pathways to contribute their data to the registry: The NBIR case report form (CRF) was designed to capture data that is required for the purposes of device tracking a federally-mandated requirement of manufacturers of breast implants. File a claim by contacting the product evaluation department at the following numbers. Retrieved from, U.S. Food And Drug Administration. Natrelle Breast Implants, please call Allergan at 1-800-433-8871. Use of the device is limited to those physicians who have the appropriate level of medical education and surgical experience in the appropriate surgical procedures. To report an adverse reaction, please call Allergan at 1.800.367.5737. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Manually enter all of your breast implant procedure data into the NBIR case report form using your computer. Will Allergan pay to have my breast implants removed? Enter your comments by clicking on the blue "Comment" button under the title. SkinMedica Purifying Foaming Wash is an over-the-counter drug product that are formulated and marketed pursuant to the FDAs governing regulations set forth at 21 CFR Part 333 Subpart D. LATISSE is an FDA-approved treatment to grow eyelashes for people with inadequate or not enough lashes. Breast implants and anaplastic large cell lymphoma. MENU Home; About; News; API . Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers. The recalled breast implants represent less than 5 percent of implants sold in the United States. This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. On July 11, 2019, the Australian Therapeutic Goods Administration proposed either canceling or suspending several textured implants because of their link to BIA-ALCL. The information provided on this website is designed to support, not replace, the discussion that exists between a patient and a physician. The safety of JUVDERM VOLLURE XC and JUVDERM VOLBELLA XC has not been studied in patients under 22 years, and the safety of JUVDERM Ultra Plus XC and JUVDERM Ultra XC has not been studied in patients under 18 years, The safety and effectiveness of treatment with JUVDERM products in anatomical regions outside of their approved uses have not been established in clinical studies, If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation, If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVDERM injectable gel treatment, Tell your doctor if you are on therapy used to reduce your bodys natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site, Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site, JUVDERM VOLUMA XC was not studied in patients with significant loose skin of the chin, neck, or jaw, The effect of JUVDERM VOLUMA XC injection into the chin on facial hair growth has not been studied, Patients who experience skin injury near the site of JUVDERM VOLUMA XC injection may be at a higher risk for adverse events, Nerve injury in the jaw (which can cause an uneven smile or facial muscle weakness), Injection site problems, including a collection of blood under the skin (hematoma) or bruising, damage to an artery or vein if KYBELLA is inadvertently injected into it, hair loss, open sores (ulcers), damage and tissue cell-death (necrosis) around the injection site, infection. 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