THIS WEEK'S ARTICLES
The Plastic Surgery Boom Drives Growth in Outpatient Surgeries - Sponsored Content
FDA Warns Cancers Can Form in Scar Tissue Around Breast Implants
The agency, still in the early stages of gathering relevant data, advises providers and patients to watch for symptoms.
The Food and Drug Administration (FDA) announced it has received reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue that forms around breast implants. It added that the lymphomas are not the same as those described in previous FDA communications as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
The FDA's safety communication, issued in September, says it is aware of fewer than 20 cases of SCC and fewer than 30 cases of various lymphomas in the capsules around breast implants. As of Sept. 1, it had received 10 Medical Device Reports (MDRs) about SCC and 12 MDRs about various lymphomas related to breast implants, respectively. The FDA continues to monitor the situation and is seeking more reports of such cancers from providers and patients to gather more data. "This is an emerging issue and our understanding is evolving," says the agency.
"While the FDA believes that occurrences of SCC or various lymphomas in the capsule around the breast implant may be rare, healthcare providers and people who have or are considering breast implants should be aware that cases have been reported to the FDA and in the literature," the agency writes, adding that the incidence rate and risk factors are currently unknown. It adds that in some cases, patients were diagnosed years after receiving breast implants. Reported signs and symptoms include swelling, pain, lumps and skin changes.
The FDA advises patients to monitor their breast implants for as long as they have them, and to speak with their surgeon or healthcare provider promptly if they notice any abnormal changes in their breasts or implants. The FDA does not recommend removal of breast implants in asymptomatic patients.
The FDA says providers should be aware that cases have been reported, and to characterize all findings and potential diagnoses when examining breast implant specimens for diagnostic evaluation. It says providers should report cases of SCC, lymphomas and any other cancers in the capsule around the breast implant to the FDA to help it identify and better understand the risks associated with the devices.
"The FDA will collaborate with other regulatory authorities, clinical and scientific experts, manufacturers, and breast implant registries to gather all available information about SCC, lymphomas and any other cancers in the capsule around the breast implant," writes the agency. "We will continue to communicate to the public on significant findings as new information and analyses become available."
Could Tattoos Replace Medical Alert Bracelets?
Microneedle patch technology could have numerous healthcare applications.
Researchers at the Georgia Institute of Technology have developed low-cost, painless, bloodless tattoos that they say could have healthcare applications.
The researchers say the tattoos, which are skin patches containing microscopic needles, could be used to cover up scars, guide cancer radiation treatments or restore nipples after breast surgery. They could also serve as an alternative to medical alert bracelets to communicate conditions such as diabetes, epilepsy or allergies.
"We've miniaturized the needle so that it's painless, but still effectively deposits tattoo ink in the skin," says Mark Prausnitz, PhD, principal investigator on a paper about the technology published in iScience. He says these microneedle patches could make medical tattoos more accessible to patients.
Microneedles have been marketed and used for cosmetic purposes, but the concept of pairing the technology with tattoos is novel, says Dr. Prausnitz, who has long studied the use of microneedle patches to painlessly administer drugs and vaccines without using hypodermic needles.
Unlike large tattoo needles that puncture repeatedly into skin, the Georgia Tech team's microneedles are described as smaller than a grain of sand and made of tattoo ink encased in a dissolvable matrix. Because they can deposit ink into skin so efficiently, the microneedles are pressed into the skin just once and then dissolve. The process involves no bleeding and takes just a few minutes.
The researchers say their microneedle patch tattoos differ from patches for pharmaceuticals or cosmetics that have dozens or hundreds of microneedles arranged in a square or circle. Instead, they can enable a provider to imprint a design that includes letters, numbers, symbols and images by arranging the microneedles in a specific pattern within a mold. The microneedles in the mold are then filled with tattoo ink and a patch backing is added for convenient handling.
When the patch is applied to the skin for a few minutes, the microneedles dissolve and release the tattoo ink, which can include black-light ink that can only be seen when illuminated with ultraviolet light. The researchers say black-light ink can provide privacy for patients who don't want the tattoo to be visible in normal light.
The Georgia Tech study found that the microneedle patch tattoos could last for at least a year and are likely to be permanent, although they could be loaded with temporary tattoo ink to address short-term medical needs.
The Plastic Surgery Boom Drives Growth in Outpatient Surgeries
Patients are seeking more procedures in breast and abdominoplasty as they look to improve their overall well-being and health.
The demand for plastic surgery has increased since the beginning of the pandemic for a variety of reasons including a renewed focus on health, improving mental and physical well-being and the opportunity to recover at home. According to a new national survey conducted by the American Society of Plastic Surgeons (ASPS), cosmetic procedures have increased with young women responsible for the steady uptick in procedures.
Three-quarters of the society's member surgeons report that their practice volumes are increasing, with 30% reporting their business has at least doubled.
Outpatient Surgery Magazine spoke to Tripp Holton, MD, a plastic surgeon in Annapolis, Maryland who is affiliated with Luminis Health Anne Arundel Medical Center to talk about the trends in plastic surgery today.
Q: Your specialties are breast reconstruction including reconstructive microsurgery as well as cosmetic plastic surgery of the face and body. Have you seen an increase in patient interest in these areas and what do you think is driving that demand?
For my practice there has been a noticeable increase in demand for aesthetic procedures since early after the beginning of the pandemic. Initially, this seemed to relate to patients' inability to travel (domestic and international) and possibly to bonuses of money associated with PPP loans, etc. Interestingly, in particular, there was an uptick in injectables and procedures for areas of the face not covered by masks such as the forehead and upper and lower eyelids as these areas remained visible. However, the trend seems to have continued beyond mask mandates, travel restrictions, strictly enforced social distancing and shelter in place recommendations. While our Millennial and Generation Z populations are lauded for valuing experiences over "things," they seem to also value looking great when they do experience things and certainly when they share their experiences visually on social media.
Q: What are the challenges of performing successful breast reduction surgery?
Breast reduction surgery is a commonly performed procedure nationally and certainly my practice echoes that trend. I refer to these procedures as "cosmedical" because they are medically necessary to address back, neck and shoulder pain while simultaneously inherently cosmetic because patients have an understandable interest in maintaining or achieving a symmetric, attractive and harmonious appearance after the surgery.
Symmetry after breast reduction does not only mean breast volume but also the position and diameter of the nipple and areola and the shape and drape of the breasts.
Achieving symmetry, often when the breast started with significant asymmetry, can be a challenge. Additionally, breast reduction surgery is invasive and requires a tremendous amount of dissection, suturing and wound healing and, accordingly, the greatest challenge to the surgeon is likely guiding the patient through the often lengthy and intensive process of healing.
Q: For abdominoplasty can you describe the challenges here? Are these higher risk surgeries?
Abdominoplasty or "tummy tuck" surgery which is often combined with liposuction in the region (flanks, back and/or upper abdomen) is a high yield procedure associated with tremendous patient satisfaction, but it can be complicated by issues such as bleeding, asymmetry, widened, raised or discolored scars, wound development and most concerning but fortunately rare deep vein thromboses (blood clots). Excellent aesthetic results after abdominoplasty hinge on competing factors: to remove as much extra skin and fat from the region as possible the surgeon must then close the incision under moderate to large amounts of tension. Too little tension typically means that not enough tissue was removed, and the result is accordingly disappointing whereas the removal of a bit too much tissue can result in more complications such as wound development and issues with the appearance of the scar.
Q: What do you do to keep the patient safe from infection and complications?
The patient is paying the surgeon for two often competing goals: they want the best looking result and they expect to be kept out of harm's way. To accomplish these competing priorities, I rely heavily on experience, judgement and technology. In particular, I ask a lot of the dressings that I use in abdominoplasty and breast reduction surgeries. Specifically, I typically use closed incision negative pressure dressings because they do several critical things for me and by proxy my patient. These advanced dressings actively manage the incisions and the surrounding soft tissues: they off load tension across the incisions, reduce swelling within and below the skin, increase blood supply to the tissue and protect the incision from contamination by creating and maintaining a sealed and sterile environment after the surgery.
Q: For wound care, what do you see as the best practices?
While wound care is a critically important process, I strive for and focus on active incision management because the Holy Grail of cosmetic surgery is to manage incisions to prevent the development of wounds. I have personally enacted a zero-tolerance policy for wound development after cosmetic procedures. To help achieve this austere but important goal I mandate that all tummy tuck and breast lift patients are managed with an advanced incisional management dressing such as a 3M™ Prevena™ Dressing along the waistline closure after abdominoplasty and a 3M™ Prevena Restor™
BellaForm™ Dressing to cover the breast after a lift especially when an implant is placed at the same time.
Q: Are you seeing more patients seeking combination procedures and what does that mean for your preparation?
Combination procedures are common. Typically, when a patient has cosmetic issues in one location they have those same issues in another region. I will often perform a breast lift and a tummy tuck or a tummy tuck and a thigh lift with or without liposuction, but I never combine more than two areas per procedure.
A little more than a decade ago surgeons were still commonly performing combined procedures informally known as total body lift, but we eventually recognized that this approach exposed patients to unnecessary risk in the form of required transfusions, infection, increased likelihood of wound development and challenges with controlling pain.
While many of my patients could benefit from procedures in more than one location, I generally limit them and myself to two regions at time. While this means more than one surgery and possibly incrementally more expense it rewards the patient with better results and fewer complications. It also allows the surgeon to revise the initial procedures while performing subsequent operations. In these cases, I am careful to optimize their care with adjunctive therapies such as regional pain blocks and advanced dressings.
Q: What do you see as the most important new trends in plastic surgery?
I have always believed that advancements in technology allow advancements in techniques. Recent trends in breast reconstruction for cancer provide an excellent example of how intelligent use of technology has informed our choice of surgeries. When I trained and when I was first in practice all of my implant-based breast reconstructions after mastectomy started with placement of a breast tissue expander beneath the patient's pectoralis major muscle. This was then followed by a series of visits for expansion and culminated in a second operation to replace the temporary device (tissue expander) and place a permanent implant into that pocket.
In 2016, I began to build all breast above the muscle since we finally had technologies that made that possible such as blood supply mapping, excellent tissue for implant support, higher quality breast prostheses and, importantly, dressings that protect the breast while improving the nascent blood supply. Shortly after switching to this new approach (pre-pectoral reconstruction) I learned that almost all of my patients could be accelerated to placement of an implant immediately rather than requiring an expander and the associated visits for expansion and final operation to exchange the expander for an implant. Now, technology had allowed the breast to be made in front of the muscle (far less pain) and with the immediate placement of the implant. With patients in far less pain we were suddenly able to safely and compassionately send patients home on that same day.
I see technology helping my cosmetic patients in much the same way. I, and now they, expect to be back to normal activity very soon after surgery.
Q: What advice would you give fellow surgeons and OR teams in the outpatient environment to create a successful practice?
As hospital systems nationwide move rapidly towards diverting less complex cases from the hospital operating rooms into high quality but lower cost ambulatory surgery centers, the intelligent practice will prepare to use these advanced technologies and supplies in that outpatient setting. When insurance-based care is transferred to the ambulatory care environment advanced therapies in the form of regional pain care and advanced dressings become even more valuable – adept practices will adapt by adopting intelligent approaches and technologies.
NOTE: For more information please go to 3M.com/PrevenaCentral
Note: Dr. Holton is a consultant and speaker for 3M due to the value that he places on the 3M products designed for management of incisions, tissue and wounds.
A Safer Option for Nipple-Sparing Mastectomy
Batwing mastopexies can improve aesthetic outcomes for women with sagging or larger breasts.
Nipple-sparing procedures, which involve surgeons preserving the nipple and surrounding tissues for use in immediate breast reconstruction using implants, have become a popular alternative for women undergoing mastectomies. Preservation of the nipple areolar complex (NAC) allows for a more natural-looking reconstruction, which leads to higher patient satisfaction. However, nipple-sparing mastectomies (NSM) are generally not offered to women with sagging or larger breasts due to complication risks.
A recent report published in Plastic and Reconstructive Surgery says women with sagging or larger breasts can benefit from the batwing incision, which consists of two semicircular incisions above the nipple connected by angled "wings" on either side of the NAC. This technique allows the surgeon to perform a breast lift at the same time as a mastectomy, the researchers say.
"Our findings show that a simultaneous batwing mastopexy can be safely performed at the time of immediate breast reconstruction, while providing comparable complication rates and improving the aesthetic outcome," says Hahns Y. Kim, MD, a plastic surgeon at Loma Linda (Calif.) University Medical Center and member of the American Society of Plastic Surgeons.
Dr. Kim and his colleagues reported their experiences employing batwing mastopexy for NSM in 80 women with larger breasts and a greater degree of ptosis, and compared the outcomes to 244 patients undergoing standard implant-based reconstruction without preserving the NAC. In an average of 16 months after mastectomy and immediate reconstruction, the two groups of women had similar outcomes. At least one complication occurred in 23.8% of operated breasts in the batwing mastopexy group and in 27.5% of the standard reconstruction group. Necrosis of the skin or nipple was less frequent in the batwing mastopexy group: 6.3% versus 11.5%.
The researchers conclude that the batwing technique provides comparable complication rates, improves aesthetic outcomes in patients with significant ptosis or macromastia, and allows nipple-sparing mastectomy to be an option for those who would otherwise be excluded.
Botox Alternative Greenlit by FDA for Treatment of Frown Lines
The promise of the new injectable centers on longer-lasting effects and less-frequent injections.
The FDA's recent approval of Daxxify for injection to temporarily improve moderate to severe frown lines is offering providers and patients an intriguing alternative to Botox, long considered the cosmetic treatment of choice for facial skin enhancements.
Revance Therapeutics, which is marketing the new injectable, says the product requires fewer injections than Botox to work over an extended period of time. It cites studies that show as few as two injections of Daxxify per year can provide a year's worth of results, and claims that some patients get six to nine months of desired outcomes from the initial injection.
Revance, which touts Daxxify as the first new long-acting neuromodulator to hit the market in 30 years, says the drug contains no human serum albumin or animal-based components. It claims the new product has been proven to be effective, generally safe and well tolerated.
Jeffrey Dover, MD, co-director of SkinCare Physicians of Chestnut Hill, Mass., says patients in studies involving the new product were highly satisfied with the results. "I look forward to helping patients who have been accustomed to a three- to four-month duration profile with conventional neuromodulators achieve yearlong results with as few as two treatments per year," he says. Data from the clinical trials that drove the FDA's approval of Daxxify shows that results were typically seen two days after the first injection.
Revance says its product will be launched soon in conjunction with a training and education program regarding its use to be held at its Nashville headquarters. The company envisions future applications for the product beyond temporary removal of frown lines, including treatment of forehead lines, crow's feet, cervical dystonia and upper limb spasticity.