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Allergan Textured Breast Implant Recall

Allergan recently issued a recall on all their textured breast implants. This was in response to concerns by the FDA and health organizations around the world about the association between Allergan textured breast implants and a rare form of cancer, ALCL.

At Burgess Plastic Surgery, Dr. Burgess has placed thousands of breast implants, most being round, smooth-shelled implants. In some cases, we have placed shaped textured-shell implants, but those devices have been either Mentor or Sientra devices.

Mentor and Sientra textured implants are not subject to the FDA recall because they carry an extremely low risk of being associated with ALCL. Our patient’s health and safety are our foremost concern. We will continue to closely monitor the scientific data and FDA guidance on all breast implants and any possible risks associated with breast augmentation surgery. Our patients with textured-shaped implants should be reassured that their risk of ALCL is extremely low and that no additional treatment is recommended.

For detailed information, here is the adapted, important part of the FDA statement on the recall of Allergan textured breast implants:

FDA STATEMENT ON RECALL OF ALLERGAN TEXTURED BREAST IMPLANTS

To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S.
based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.

These products have the same BIOCELL textured surface (shell), which is a unique surface used only by Allergan. A list of Allergan’s BIOCELL textured devices marketed in the U.S. that will be voluntarily recalled can be found at https://www.allergan.com

The FDA’s analysis was attributed to a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time of their BIA- ALCL diagnosis. The manufacturer and/or texture is unknown for the remaining 20 reported deaths from BIA-ALCL.

Based on the currently available information, including the newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan’s Biocell BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.

The FDA will continue to evaluate any new information and may, as a result, take action regarding other breast implants, if warranted. Although most cases of BIA-ALCL are associated with the use of textured breast implants, particularly macro-textured implants – such as those made by Allergan, we are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants. Therefore, at the present time, we believe all individuals who are considering a breast implant of any type be informed of the risk of developing BIA-
ALCL.

BIA-ALCL is not breast cancer – it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. At this time, the overall incidence of developing BIA-ALCL is considered to be low; however, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated. In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant; however, some patients may require treatment with chemotherapy and/or radiation therapy.

Patients: Important Recommendations If You Have Allergan BIOCELL Breast Implants

If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to your health care provider.

Know the symptoms of BIA-ALCL – primarily persistent swelling or pain near the breast implant – and monitor the area around your breast implants for any changes.

If you experience any of these symptoms or other changes, talk to your health care provider regarding the need for further evaluation. Evaluation for BIA-ALCL typically involves a physical exam, imaging, and/or assessment of the fluid or tissue around the breast implant. It is important to undergo an evaluation to diagnose BIA-ALCL since a confirmed BIA-ALCL diagnosis may change the type of operation that should be performed.

Based on discussions with your health care provider, patients with confirmed BIA-ALCL should undergo implant removal and removal of the surrounding scar capsule, which is a more extensive operation than implant removal alone.

As with any implanted device, it is good to keep a record of the device manufacturer, unique device identifier, and implant model name. You may have received this information on a patient device card from your surgeon. If you would like to obtain any of this information, consider asking your surgeon or obtaining the record of your surgery (operative notes) from the facility where it was performed.

Understand that most cases of BIA-ALCL occur many years after breast implant placement. Talk to your surgeon about your risk of developing BIA-ALCL. (This ends the FDA update section.)

Remember that Dr. Burgess cares about patient safety and encourages her patients to call or come into the office for any questions or concerns. Dr. Burgess will remove or replace implants, if desired by her patients, and she encourages an annual visit in the office for those with silicone implants. Keep in mind that the Mentor and Sientra implants are not subject to the textured implant recall. Please note that patients who would like to have their implants removed or replaced would be responsible for the additional cost of surgery and that insurance may not cover this as it is not recommended by the FDA for Sientra and Mentor implants.

Get Selfie-Ready with Non-Surgical Lip Augmentation

Brunette woman in front of blue background taking selfie to show off full, plump lips after fillersDo you have lips that are thinner than you’d like? Full, plump lips are a sign of youthfulness and vitality, but many people have lips that are either naturally thin or have thinned out with age. Thin or asymmetrical lips can make you self-conscious about your smile, and you may end up avoiding photos or using makeup or filters to create an impression of plumper lips.

Here at Burgess Plastic Surgery in Portland, OR, we offer a number of injectable fillers that can be used to plump and shape the lips. Lip filler injections are a quick and relatively painless procedure, with immediately visible results. Call our office at 503-699-6464 to schedule your appointment today.

Benefits of Lip Fillers

Plumping your lips with fillers is a safe and effective way to get a full, youthful pout. Today, there are many different types of fillers on the market, each designed to accomplish a specific function, such as smoothing fine lines and wrinkles, augmenting the cheeks or chin, or augmenting the lips.

Gone are the days when lip fillers could look unnatural or give you “duck lips”; we are able to give you beautiful, natural results that are harmonious with your facial features. Other benefits of lip fillers include:

  • Short treatment time requiring no incisions
  • Relatively short healing time; you will have some bruising and swelling, but with proper care this should subside over a few days
  • Highly customizable to each individual
  • Reversible should you for some reason decide you don’t like your new, fuller lips

We will listen carefully to your concerns and goals during your appointment and help you to achieve the best results possible.

Combination Injectable and Non-Surgical Treatments

If you have other concerns besides just your lips, such as wrinkles or volume loss, we can perform multiple injectable and non-surgical treatments at the same time in what’s known as a “liquid facelift.” Common combination treatments include:

  • BOTOX™, Dysport, Xeomin, or Jeuveau: These treatments help to smooth expression lines in the upper face. If you have crow’s feet, forehead lines, or deep lines between the brows (also known as “11s”), consider one of these treatments.
  • Dermal fillers: Aside from the lips, dermal fillers can also help to give you more pronounced cheekbones, reduce small lines around the lips, smooth nasolabial folds, enhance the chin, and more.
  • Non-surgical skin tightening: If you’re just beginning to see signs of laxity and drooping in your skin, a non-surgical skin tightening procedure such as Ultherapy or ThermiTight may help.

Combining these procedures can revive and refresh your appearance significantly, allowing you to feel comfortable and confident when friends or family whip out the camera.

Schedule Your Lip Augmentation Appointment Today

If you’re interested in plumping your lips with dermal fillers, please call Burgess Plastic Surgery today at 503-699-6464 to schedule your appointment. We serve patients in Lake Oswego and other nearby areas of greater Portland, Oregon.

Is Jeuveau™ the New BOTOX® Cosmetic?

Woman with style hair making an ironic face and wondering about Newtox injections

There’s a new injectable neurotoxin on the block, and its name is Jeuveau™. It’s also been lovingly coined “NewTox,” because it works the same way as BOTOX® Cosmetic. One is not better than the other, but treatments may indicate that Jeuveau™ injections may last longer. We also know many of our patients are BOTOX® loyalists, and we still trust its results, reputation and efficacy as well. Therefore, we’re happy to provide both of these options to patients at our Lake Oswego practice. Give both a try and see which one you prefer! To learn more, please call Burgess Plastic Surgery at 503-699-6464.

Hello, Jeuveau™: Another Option for Facial Rejuvenation

Jeuveau™ – a name inspired by “nouveau,” meaning “new” – is highly structurally similar to BOTOX® Cosmetic. This NewTox injectable was FDA-approved specifically for cosmetic rejuvenation this past February, which means it has received the FDA’s stamp of approval for safety and effectiveness for its intended use.

Jeuveau™ is FDA approved to treat:

  • Vertical lines between eyebrows (also called glabellar lines or “11s”)

The two injectables are different strains of the same toxin. BOTOX® is onabotulinumA, while Jeuveau™ is prabotulinumtoxinA. The former is created by Allergan at their Westport, Ireland facility, while the latter comes to us from the company Evolus, out of Seoul, South Korea. The injections work the same way, by temporarily halting the over-activity of specific muscles that cause furrows and wrinkles. Both injectables allow you to retain your emotive expression, but simply relax the contractions that cause unsightly wrinkles.

The Jeuveau™ Treatment Process

This fast, no-downtime treatment includes the following:

  • Visit our office for the injection appointment
  • Relax while we inject Jeuveau™ in the treatment areas
  • Leave the office with the option to get right back to your normal routine – there’s no downtime

The vast majority of people describe these injections as extremely tolerable. Most people don’t even need a topical anesthetic. You will feel a slight prick as the injection is administered.

Patients can start to see results around 3-5 days after injection, with full results expected by 2 weeks. The results may last 3-4 months, just like BOTOX®, and potentially a little longer. You can schedule another injection appointment after 90 days to maintain the effect.

“I had it on a Friday afternoon and by Sunday morning, my forehead was smooth and lines were erased. I feel that it set up quickly and with greater results”  -happy patient from Burgess Plastic Surgery

Ready to Give Jeuveau™ a Try?

Burgess Plastic Surgery is excited to offer the new kid on the block – Jeuveau™. It’s one of several injectables offered so that we can tailor treatment to you and your skin. To learn more, please call the practice of board-certified cosmetic and reconstructive surgeon Dr. Elisa A. Burgess at 503-699-6464. We are passionate about providing results for our patients. Men and women from Portland and across the surrounding areas visit us at our Lake Oswego practice.

Skin Care Tips for Skin Cancer Awareness Month

Young woman in Oregon applying sunscreen to prevent skin cancer and premature aging

At Burgess Plastic Surgery, we want you to love your skin. Your skin will feel radiant and refreshed by the professional skin care services at our Lake Oswego practice. We know that beautiful skin is healthy skin. One of the most significant factors related to skin health and aging is sun exposure. Ultraviolet radiation leads to wrinkles, volume loss, discoloration and an increased risk for melanoma and other skin cancers.

It’s National Skin Cancer Awareness Month and below you’ll find our tips and advice for everyday sun protection. The seasons ahead of us in Oregon mean time outdoors with friends and loved ones. Take these simple steps to reduce your risk of harmful sun damage. We also offer a wide variety of medical-grade products, which erase past sun damage, repair current damage and protect your skin from the elements.

Renew and Protect with Medical-Grade Skin Care Products

Our products come from leading brands, including:

  • ZO® Skin Health. In addition to sun protection products, the ZO line targets aging, discoloration, acne, rosacea and pigmentation.
  • Neocutis. This innovative line includes an SPF-30 day cream called Journee. Neocutis uses processed human skin cell proteins, which are rich in beneficial growth factors and antioxidants.
  • Epionce®. This line features a wide array of products targeted at improving the wellness and health of your skin. They fight inflammation and rebuild the outer protective layer of cells.
  • Teoxane. The RHA serum by Teoxane smoothes and brightens skin. Working from the inside out, this serum renews cells and restructures tissue. It’s a form of hyaluronic acid, so it attracts and retains hydrating water molecules in your skin.

A Hydrafacial is another great way to prep your skin for spring and summer. This facial is a comprehensive approach to refreshing your skin. It works similarly to a chemical peel, but it also hydrates your skin and protects it with antioxidants and a variety of optional boosters. It cleanses, extracts, hydrates and protects. You’ll head into the sunny season with vibrant, glowing skin.

For those who have visible sun damage, there are options to diminish the pigmentation. Treatments like IPL (intense pulse light) or a Clear + Brilliant laser, are devices that target sun damage by turning over superficial pigment. Series of treatments can help clear the skin and slow down future brown spots from forming.

Before and after of skin care treatment

Protect Your Skin this Summer

Skin cancer is the most common cancer in the United States, according to the Skin Cancer Foundation. About 5 million cases are diagnosed in our country each year. UV exposure is the most common and widespread contributing factor to skin cancer. It is also one of the most preventable forms of cancer. Because sun exposure is the largest risk factor, you can protect yourself by protecting your skin. Here are a few ways to do so:

  • Wear a wide-brimmed hat when you’re outside
  • Wear loose long sleeves and pants if you’ll be out in the sun for a while
  • Wear sunscreen for extended outdoors time and an SPF-rated cream or foundation daily
  • Reapply sunscreen every 2 hours if you’re hiking, boating, playing volleyball, swimming, etc.
  • Stay in the shade, if possible, between the hours of 10am-2pm, which is when the sun is most intense

Unfortunately, we continue to see patients who keep tanning because they think their skin looks better because it evens out their brown spots. However, this only creates more brown spots and greatly increases your risk of skin cancer. It is best to break out of this cycle of tanning. As Dr. Obagi, of our medical grade skin care line, Z.O., says, “a tan is your skin crying for help.”

Consult your doctor if you notice any moles, spots or discolorations on your skin that concern you. Generally, you should address any new changes, especially if it’s a new growth or a sore that doesn’t heal. Your dermatologist can evaluate these marks.

Find Out Which Skin Treatments are Right for You

If you are interested in rejuvenating your skin and protecting it from UV radiation with professional products, please arrange an appointment at Burgess Plastic Surgery by calling 503-699-6464. Dr. Elisa Burgess is an experienced cosmetic surgeon who is personally committed to her patients’ best results. Our friendly, state-of-the-art practice is located in Lake Oswego, and we proudly care for patients from Portland and all of the surrounding areas in Oregon.

How Does a HydraFacial Work?

Woman Getting HydraFacial at Burgess Plastic Surgery

A HydraFacial is a popular skin care treatment that combines the power of a soothing facial with pore-cleansing dermabrasion to give you a radiant complexion. This procedure is quick, painless, and can benefit just about anyone looking to improve the appearance of their skin.

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