RESOURCES
for you
Actual Natrelle INSPIRA® patients.
Individual results may vary.
Individual results may vary.
resources
for your practice
Go GUMMY and get support
The decision to move forward with breast augmentation is a big one. In addition to
your plastic surgeon, the following resources are available for you as you consider all your options.
your plastic surgeon, the following resources are available for you as you consider all your options.
Natrelle® ConfidencePlus® Warranty Brochure
An overview of coverage for your breast implants.
Breast Augmentation Guide
Information you need to know about the breast implant options available with Natrelle®.
Natrelle® Augmentation Brochure
Explore your options for breast augmentation with the Natrelle INSPIRA® Collection.
download
Implant-related Conditions Brochure
Facts about complications that may occur with breast implants to help you make the best decision for you.
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Rewards
Who doesn’t love to be rewarded? Learn more about the
Brilliant Distinctions® Rewards Program and the Natrelle® Gel Rewards Program.
Rewards
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peace of mind
Make a confident choice with the
Natrelle®
ConfidencePlus® warranty program.
Warranty
Want a look that's
uniquely you?
See what going gummy looks like with before-and-after photos of real patients.
Results
Natrelle® Breast Implants Important Information
Who may get breast implants?
Natrelle® Breast Implants are approved for women for the following:
Natrelle® Breast Implants are approved for women for the following:
- Breast augmentation for women at least 22 years old for silicone-filled implants.
-
Breast augmentation for women at least 18 years old for saline-filled 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. - Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.
IMPORTANT SAFETY INFORMATION
Who should NOT get breast implants?
Who should NOT get breast implants?
- 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.
What should I know before getting breast implants?
- Breast implants are not lifetime devices, and not necessarily a one-time surgery.
- Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implant(s) removed and not replaced, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast, which may be permanent.
- Breast implants may affect your ability to breast-feed, either by reducing or eliminating milk production.
- Rupture of a silicone-filled breast implant is most often silent and may not be detected by you or your doctor. You should have an MRI 3 years after your surgery and then every 2 years after that for as long as you have your breast implants to determine if rupture is present. If implant rupture is noted on an MRI, you should have the implant removed, with or without replacement.
- With breast implants, a routine screening mammography and self-examinations for breast cancer will be more difficult. Ask your doctor to help you distinguish the implant from your breast tissue. Symptoms of a ruptured implant may be hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening. Tell your doctor of these symptoms and remove ruptured implants.
- Inform any other doctor who treats you of the presence of your implants to minimize the risk of damage to the implants.
What should I tell my doctor?
Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:
Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:
- Autoimmune diseases (for example, lupus and scleroderma).
- A weakened immune system (for example, currently taking drugs that weaken the body’s natural resistance to disease).
- Planned chemotherapy following breast implant placement.
- Planned radiation therapy to the breast following breast implant placement.
- Conditions or medications that interfere with wound healing and blood clotting.
- Reduced blood supply to breast tissue.
- Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders with your surgeon prior to surgery. Patients 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.
What are some complications with breast implants?
Key complications are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and severe capsular contracture (severe scar tissue around the implant). Other complications include asymmetry, nipple/breast/skin sensation changes, scarring, or wrinkling/rippling. Talk to your doctor about other complications.
Key complications are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and severe capsular contracture (severe scar tissue around the implant). Other complications include asymmetry, nipple/breast/skin sensation changes, scarring, or wrinkling/rippling. Talk to your doctor about other complications.
Talk to your doctor. For more information see the patient brochures at www.allergan.com/labeling/usa.htm.
To report a problem with Natrelle® Breast Implants, please call Allergan at 1-800-433-8871.
Natrelle® Breast Implants are available by prescription only.
Natrelle® 133 Tissue Expanders Important Information
Approved Uses
Natrelle® 133 Tissue Expanders are approved for breast reconstruction following mastectomy, treatment of underdeveloped breasts and treatment of soft tissue deformities.
Natrelle® 133 Tissue Expanders are approved for breast reconstruction following mastectomy, treatment of underdeveloped breasts and treatment of soft tissue deformities.
IMPORTANT SAFETY INFORMATION
Who should NOT get tissue expanders?
Do not use if you:
Who should NOT get tissue expanders?
Do not use if you:
- Already have implanted devices that would be affected by a magnetic field.
- Have tissue unsuitable for expansion.
- Have an active infection or a residual gross tumor at the expansion site.
- Are undergoing adjuvant radiation therapy.
- Have a physiological condition (e.g., obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use certain drugs (including those that interfere with blood clotting or affect tissue viability) that may result in a high risk of surgical and/or postoperative complications.
What else should I consider?
- Natrelle® 133 Tissue Expanders should NOT be used in patients who already have implanted devices that would be affected by a magnetic field.
- Active infection anywhere may increase risk of infection around the tissue expander. Certain infections may require premature removal of the device.
- Natrelle® 133 Tissue Expanders are temporary devices, and are not to be used for permanent implantation or beyond 6 months. Tissue expansion in breast reconstruction typically requires 4 to 6 months.
What are possible complications?
Deflation, tissue damage and/or appearance of the implant through the skin, infection, unwanted shape, unintended blood or fluid collection, capsular contracture (tightening of scar tissue that causes the breast to harden), premature device removal, bone/pain/sensation changes, and inflammation.
Deflation, tissue damage and/or appearance of the implant through the skin, infection, unwanted shape, unintended blood or fluid collection, capsular contracture (tightening of scar tissue that causes the breast to harden), premature device removal, bone/pain/sensation changes, and inflammation.
For more information, please visit www.allergan.com/labeling/usa.htm.
To report a problem with Natrelle®, please call Allergan at 1-800-433-8871.
Natrelle® 133 Tissue Expanders are available by prescription only.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Approved Uses
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
Approved Uses
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
BOTOX®
Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.
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, crow’s feet lines, and/or forehead lines.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic.
If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects.
Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.
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.
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.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-678-1605.
Please see BOTOX® Cosmetic full Product Information including Boxed Warning and
Medication Guide.
CoolSculpting® has not been studied with Natrelle® breast implants, nor is it intended to be used in combination with Natrelle® breast implants.
CoolSculpting® Important Information
Uses
The CoolSculpting® procedure 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. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. The CoolSculpting® procedure is not a treatment for weight loss.
Important Safety Information
The CoolSculpting® procedure is not for everyone. You should not have the CoolSculpting® procedure if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
Tell your doctor if you have any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.
During the procedure you may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb. 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.
Rare side effects may also occur. CoolSculpting® may cause a visible enlargement in the treated area which may develop two to five months after treatment and requires surgical intervention for correction.
Please see full Important Safety Information for additional information.
SkinMedica® is a physician-dispensed, cosmetic, and nonprescription skin care product line.
Sunburn alert: AHA/BHA Exfoliating Cleanser contains an alpha-hydroxy acid (AHA) that may increase the skin’s sensitivity to the sun and particularly the possibility of sunburn. Patients should use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week following discontinuation.
Most SkinMedica® products are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These SkinMedica® products have not been approved by the FDA, and the statements about SkinMedica® products herein have not been evaluated by the FDA.
SkinMedica® TOTAL DEFENSE + REPAIR Broad Spectrum SPF 34 Sunscreen is an over-the-counter drug product that is formulated and marketed pursuant to FDA’s governing regulations set forth at 21 CFR Part 352.
Sunburn alert: AHA/BHA Exfoliating Cleanser contains an alpha-hydroxy acid (AHA) that may increase the skin’s sensitivity to the sun and particularly the possibility of sunburn. Patients should use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week following discontinuation.
Most SkinMedica® products are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These SkinMedica® products have not been approved by the FDA, and the statements about SkinMedica® products herein have not been evaluated by the FDA.
SkinMedica® TOTAL DEFENSE + REPAIR Broad Spectrum SPF 34 Sunscreen is an over-the-counter drug product that is formulated and marketed pursuant to FDA’s governing regulations set forth at 21 CFR Part 352.
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Natrelle® Breast Implants Important Information
Who may get breast implants?
Natrelle® Breast Implants are approved for women for the following:
Natrelle® Breast Implants are approved for women for the following:
- Breast augmentation for women at least 22 years old for silicone-filled implants.
-
Breast augmentation for women at least 18 years old for saline-filled 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. - Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.
IMPORTANT SAFETY INFORMATION
Who should NOT get breast implants?
Who should NOT get breast implants?
- 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.
What should I know before getting breast implants?
- Breast implants are not lifetime devices, and not necessarily a one-time surgery.
- Many of the changes to your breasts following implantation cannot be undone. If you later choose to have your implant(s) removed and not replaced, you may experience unacceptable dimpling, puckering, wrinkling, or other cosmetic changes of the breast, which may be permanent.
- Breast implants may affect your ability to breast-feed, either by reducing or eliminating milk production.
- Rupture of a silicone-filled breast implant is most often silent and may not be detected by you or your doctor. You should have an MRI 3 years after your surgery and then every 2 years after that for as long as you have your breast implants to determine if rupture is present. If implant rupture is noted on an MRI, you should have the implant removed, with or without replacement.
- With breast implants, a routine screening mammography and self-examinations for breast cancer will be more difficult. Ask your doctor to help you distinguish the implant from your breast tissue. Symptoms of a ruptured implant may be hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning, or hardening. Tell your doctor of these symptoms and remove ruptured implants.
- Inform any other doctor who treats you of the presence of your implants to minimize the risk of damage to the implants.
What should I tell my doctor?
Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:
Tell your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher:
- Autoimmune diseases (for example, lupus and scleroderma).
- A weakened immune system (for example, currently taking drugs that weaken the body’s natural resistance to disease).
- Planned chemotherapy following breast implant placement.
- Planned radiation therapy to the breast following breast implant placement.
- Conditions or medications that interfere with wound healing and blood clotting.
- Reduced blood supply to breast tissue.
- Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders with your surgeon prior to surgery. Patients 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.
What are some complications with breast implants?
Key complications are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and severe capsular contracture (severe scar tissue around the implant). Other complications include asymmetry, nipple/breast/skin sensation changes, scarring, or wrinkling/rippling. Talk to your doctor about other complications.
Key complications are reoperation, implant removal with or without replacement, implant rupture with silicone-filled implants, implant deflation with saline-filled implants, and severe capsular contracture (severe scar tissue around the implant). Other complications include asymmetry, nipple/breast/skin sensation changes, scarring, or wrinkling/rippling. Talk to your doctor about other complications.
Talk to your doctor. For more information see the patient brochures at www.allergan.com/labeling/usa.htm.
To report a problem with Natrelle® Breast Implants, please call Allergan at 1-800-433-8871.
Natrelle® Breast Implants are available by prescription only.
Natrelle® 133 Tissue Expanders Important Information
Approved Uses
Natrelle® 133 Tissue Expanders are approved for breast reconstruction following mastectomy, treatment of underdeveloped breasts and treatment of soft tissue deformities.
Natrelle® 133 Tissue Expanders are approved for breast reconstruction following mastectomy, treatment of underdeveloped breasts and treatment of soft tissue deformities.
IMPORTANT SAFETY INFORMATION
Who should NOT get tissue expanders?
Do not use if you:
Who should NOT get tissue expanders?
Do not use if you:
- Already have implanted devices that would be affected by a magnetic field.
- Have tissue unsuitable for expansion.
- Have an active infection or a residual gross tumor at the expansion site.
- Are undergoing adjuvant radiation therapy.
- Have a physiological condition (e.g., obesity, smoking, diabetes, autoimmune disease, hypertension, chronic lung or severe cardiovascular disease, or osteogenesis imperfecta) or use certain drugs (including those that interfere with blood clotting or affect tissue viability) that may result in a high risk of surgical and/or postoperative complications.
What else should I consider?
- Natrelle® 133 Tissue Expanders should NOT be used in patients who already have implanted devices that would be affected by a magnetic field.
- Active infection anywhere may increase risk of infection around the tissue expander. Certain infections may require premature removal of the device.
- Natrelle® 133 Tissue Expanders are temporary devices, and are not to be used for permanent implantation or beyond 6 months. Tissue expansion in breast reconstruction typically requires 4 to 6 months.
What are possible complications?
Deflation, tissue damage and/or appearance of the implant through the skin, infection, unwanted shape, unintended blood or fluid collection, capsular contracture (tightening of scar tissue that causes the breast to harden), premature device removal, bone/pain/sensation changes, and inflammation.
Deflation, tissue damage and/or appearance of the implant through the skin, infection, unwanted shape, unintended blood or fluid collection, capsular contracture (tightening of scar tissue that causes the breast to harden), premature device removal, bone/pain/sensation changes, and inflammation.
For more information, please visit www.allergan.com/labeling/usa.htm.
To report a problem with Natrelle®, please call Allergan at 1-800-433-8871.
Natrelle® 133 Tissue Expanders are available by prescription only.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Approved Uses
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
Approved Uses
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
BOTOX®
Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.
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, crow’s feet lines, and/or forehead lines.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic.
If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects.
Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.
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.
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.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-678-1605.
Please see BOTOX® Cosmetic full Product Information including Boxed Warning and
Medication Guide.
CoolSculpting® has not been studied with Natrelle® breast implants, nor is it intended to be used in combination with Natrelle® breast implants.
CoolSculpting® Important Information
Uses
The CoolSculpting® procedure 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. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments. The CoolSculpting® procedure is not a treatment for weight loss.
Important Safety Information
The CoolSculpting® procedure is not for everyone. You should not have the CoolSculpting® procedure if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
Tell your doctor if you have any medical conditions including recent surgery, pre-existing hernia, and any known sensitivities or allergies.
During the procedure you may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb. 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.
Rare side effects may also occur. CoolSculpting® may cause a visible enlargement in the treated area which may develop two to five months after treatment and requires surgical intervention for correction.
Please see full Important Safety Information for additional information.
SkinMedica® is a physician-dispensed, cosmetic, and nonprescription skin care product line.
Sunburn alert: AHA/BHA Exfoliating Cleanser contains an alpha-hydroxy acid (AHA) that may increase the skin’s sensitivity to the sun and particularly the possibility of sunburn. Patients should use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week following discontinuation.
Most SkinMedica® products are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These SkinMedica® products have not been approved by the FDA, and the statements about SkinMedica® products herein have not been evaluated by the FDA.
SkinMedica® TOTAL DEFENSE + REPAIR Broad Spectrum SPF 34 Sunscreen is an over-the-counter drug product that is formulated and marketed pursuant to FDA’s governing regulations set forth at 21 CFR Part 352.
Sunburn alert: AHA/BHA Exfoliating Cleanser contains an alpha-hydroxy acid (AHA) that may increase the skin’s sensitivity to the sun and particularly the possibility of sunburn. Patients should use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week following discontinuation.
Most SkinMedica® products are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These SkinMedica® products have not been approved by the FDA, and the statements about SkinMedica® products herein have not been evaluated by the FDA.
SkinMedica® TOTAL DEFENSE + REPAIR Broad Spectrum SPF 34 Sunscreen is an over-the-counter drug product that is formulated and marketed pursuant to FDA’s governing regulations set forth at 21 CFR Part 352.
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