Injectable fillers, liposuction and eyelid surgery used to be the most commonly requested items on plastic surgeons’ menus. Now, safety information is patients’ biggest demand. Focused on—but not limited to—the health hazards of breast implants, the new concern was sparked by an October 2019 FDA recommendation that “a boxed warning, patient decision checklist, and patient information booklet/brochure specific to the breast implant should be provided by manufacturers and given to patients prior to implantation.”
It sounds like a reasonable idea for all breast implants, but the FDA only referred to implants with textured shells, not smooth. Many patients don’t know the difference or can’t remember what kind they have. “Our office phone was ringing constantly,” says Dr. Gary Wingate of Legacy Plastic Surgery. “While the concern was alarming, it was also a good opportunity for patient education.”
Breast implants can be filled with either saline or silicone. “There isn’t a huge visual difference, but they do feel different,” says Dr. Ryan Hoffman of Main Line Institute of Plastic Surgery. “Silicone feels more natural to the patient and anyone who touches them.”
Implants are covered with shells. Smooth ones are round and used for both cosmetic enhancement and reconstructing the breasts of women who’ve had mastectomies. Textured shells are more commonly used for breast reconstruction “to recreate that teardrop shape and a natural looking slope,” Wingate says.
Within three to four days of surgery, capsules of collagen form around implants. It’s a natural part of the healing process and occurs with implanted medical devices of all kinds. Problems arise if a tumor forms in that collagen capsule. Understandably, this can provoke anxiety in any woman—especially those who’ve survived breast cancer.
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Ruptures are another risk, and they can happen with both textured and smooth implants. The third risk is breast-implant illness, an unproven but documented condition with a suite of symptoms that mirror autoimmune diseases. Fatigue, hair loss, headaches, chronic pain, insomnia, plus neurological and hormonal dysfunctions, are among the problems reported by some women following breast implant surgeries.
“We acknowledge that it exists, but there’s no scientific proof that there’s a one-to-one relationship between breast implants and illness,” says Hoffman. “Nonetheless, there are women who say they have an autoimmune disorder from breast implants, and we take that seriously.”
Lymphoma is another associated disease, but it’s not proven to have a direct correlation to silicone breast implants. “If there’s rupture or silicone bleeds through the shell, the body doesn’t absorb it and it can form a capsule,” says Dr. Mark Ginsburg of Providence Facial Plastic & Cosmetic Surgery.
There is a rare form of lymphoma associated with silicone, Ginsburg says, but ruptures are rare. “It was a potential problem with older implants, but the newer implants are made differently. Barring a car accident or serious impact, new implants shouldn’t rupture.”
Hoffman agrees. “I truly feel that today’s silicone implants are very, very safe. It is a foreign body, but the implants have minimal risk for rupture and leakage.”
Rupture or not, some women’s advocates accuse Allergan and other pharmaceutical giants of hiding important information about implants’ health risks. “I can’t change policies at those companies, but I can ensure that my patients always receive educational materials about risks and benefits prior to surgery,” Ginsburg says. “That’s my responsibility as a physician.”
The FDA now recommends that “a boxed warning generally inform patients that: breast implants are not considered lifetime devices; the chance of developing complications increases over time; some complications will require more surgery; and breast implants have been associated with the risk of developing BIA-ALCL [breast implant associated anaplastic large cell lymphoma] and may be associated with systemic symptoms.”e
What’s not recommended: immediate implant removal. Unless women are exhibiting symptoms, physicians and the FDA advise against it. Ginsburg, Hoffman and Wingate concur that asymptomatic patients needn’t go through another surgery—even those with textured implants. “Removal won’t necessarily reduce their risk of developing problems,” Wingate says. “It might, but there isn’t clinical data to support that.”
Instead, Wingate suggests increased surveillance. His rigorous plan includes annual physical exams, plus imaging and biopsies if problems arise.
Tumors and ruptures can often be detected with imaging. The FDA’s updated screening guidelines suggest an ultrasound or MRI five to six years after surgery and every two years after. Hoffman and Ginsburg recommend imaging every three years.
Concerns over breast implants and other surgeries continue to fuel the popularity of non-invasive cosmetic procedures. Botox remains the queen of the wrinkle-reducing injectables, but there’s a new contender for the crown. Dubbed “new-tox,” Jeauveau claims to reduce the “elevens”—those pesky, persistent wrinkles between the eyebrows. While its substance is similar to Botox, Jeuveau is less expensive.
Unfortunately, it’s also less effective. Where Botox lasts three to four months in almost every patient, it’s a maximum of three months for Jeuveau. In some patients, it doesn’t even last that long. “I don’t actively recommend it because my patients want their injectables to last,” Hoffman says. “For some things, a good deal is not appropriate. Your face is one of them. That’s not where we cut corners.”
Ginsburg has had similar experiences with Jeuveau, and Botox remains his neurotoxin of choice. “Unless there’s something with a distinct advantage over Botox, I don’t foresee a product getting a lot of attention from patients,” he says.
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Also getting a great deal of attention of late is the so-called O-Shot. Made famous in October 2019 when a 50-something, newly single cast member of The Real Housewives of Orange County had it done on camera, the O-Shot is now one of the most requested procedures at Claytor Noone Plastic Surgery. The 15-minute in-office treatment “volumizes and helps build collagen in vaginal tissue and sensitizes the G-spot to enhance the opportunity for orgasm,” says Dr. Brannon Claytor.
All women are eligible for O-Shots, but in Claytor’s practice, the biggest demand is among patients 40 to 60 years old who’ve had children. As Claytor explains, vaginal birth can negatively impact women’s pelvic floor and cause laxity in the sphincter along the urethra pathway. Hormonal changes in menopause—and a host of medications, including breast cancer fighter Tamoxifen—can also cause vaginal dryness. The O-Shot and other vaginal rejuvenation modalities attempt to repair that tissue damage and reduce or eliminate urinary stress incontinence.
For this procedure, blood is drawn from the patients’ arms and put through a dual-spin centrifuge to separate and concentrate platelet-rich plasma. PRP contains elements that improve tissue growth. Via a syringe, the PRP is injected into a patient’s clitoris and the anterior vault of her vagina. The process of injecting PRP through the syringe causes platelets to release cytokines, which increase the growth of collagen in vaginal tissue, Claytor says.
After-care is minimal. A sanitary pad may be needed to absorb spotting, and there may be localized soreness. Some patients experience immediate results; others feel the full effects within four weeks. Based on patients’ responses, the procedure may need to be repeated every six months, though none of Claytor’s patients mind repeating the treatment. “We started doing O-Shots eight months ago, and 100 percent of our patients have been ecstatic with the results,” Claytor says.
Women looking for clinical proof of efficacy won’t find it, but a second opinion is available from the American Society of Plastic Surgeons. “The preliminary evidence indicates that these shots can enhance the orgasms of some women,” the ASPS noted in a written statement. “However, in the woman who has never achieved orgasm, they are unlikely to help. As with many treatments in the growing field of female genital procedures, we will have a greater understanding of their effectiveness when we have rigorous scientific studies.”
Not all Main Line surgeons are on board the O-train. “The O-Shot is outside my comfort zone, literally,” says Hoffman. “Everyone has their line, and mine is that I’m not going inside. I stay outside.”
By that, Hoffman is referring to labiaplasty, the surgical procedure that corrects asymmetry and removes excess skin. Both of those things can cause irritation and interfere with sex, he explains. Requested by moms who’ve delivered babies vaginally and those unhappy with their genital appearance, labioplasty is a minimally invasive procedure, though it does require two to three days of recovery time. Patients should refrain from exercise for two weeks and sex for six weeks. “The results are permanent,” Hoffman says.
Many physicians attribute the growing popularity of vaginal rejuvenation to social media. That’s also true of Brazilian butt lifts, breast implants, lip injections and other cosmetic procedures. Awareness isn’t a bad thing, and education is always great—so long as it comes from reliable sources. “Good physicians provide good information about recovery, risks and results,” says Hoffman, echoing his colleagues’ sentiments.
But potential patients are now looking to social media influencers for inspiration. Some cosmetic surgeons and med-spas give free injections and other treatments to women with large social media followings. In exchange, these patients post glowing reviews and before-and-after photos, many of which are Photoshopped.
Hoffman is skeptical of any plastic surgeon who works with influencers. “I’m trying to keep my Instagram as professional as possible,” he states. “Using it as an adjunct for your practice is fine, but there’s a line where you’re still a doctor. It’s a slippery slope.”
Hoffman will post self-described “gory” pictures of surgical procedures, and he frequently shows before-and-after shots. So does Claytor, especially when he’s introducing new techniques.
Few local physicians, however, have as much Instagram fun as Dr. Jason Bloom of Bloom Facial Plastic Surgery. He’s developed a hearty following for his surgical snaps and humorous commentary. His posts attract patients from far and wide. “I just had a husband and wife fly in from Montana,” Bloom says. “They both got face lifts and neck lifts, and they had their eye lids done.”
As a paid advisor for several pharmaceutical companies, Bloom has the inside scoop on what’s next in the cosmetic enhancement industry. He travels around North America demonstrating just-approved products and testing injectables and technologies that are in FDA clinical trials. He even acquired a Canadian medical license to learn about a new hyaluronic acid injectable that’s about to be released in the U.S. “There are so many new products about to be introduced that 2020 will be a huge year for cosmetic procedures,” Bloom promises.
First on the list is Restylane Kysse, the product that took him to Canada. Pronounced “kiss,” the filler is specifically for lip augmentation. Already the most used lip filler in Canada, Europe and Asia, Kysse should receive FDA approval in early 2020. “The substance is very soft, so it moves with the mouth, which is a concentric muscle,” Bloom says. “You don’t want something hard or stiff on your lips. This is also good for augmentation because it doesn’t cause much swelling after injected.”
Next is RT002, an injectable neuromodulator aiming at the Botox market. RT002’s parent company, California-based Revance, touts an efficacy of up to eight months—almost double that of Botox. Also known as Daxi, RT002 successfully completed Phase 3 clinical trials and is awaiting FDA approval. “Revance took a lot of people from Allergan’s Botox team to launch the company,” Bloom says. “I’ve been to the facility. It’s really impressive.”
Collagenase clostridium histolyticum doesn’t sound like something to get excited about, but Bloom says it could be the next big advance in cellulite reduction. More collagen isn’t always a good thing. It can form scar bands between skin and underlying tissue, and that creates cellulite. “The fat herniates or pops up between the bands,” Bloom says. “That creates pits, hills and valleys.”
Bloom describes CCH as “an injectable chemical collagen knife” that may reduce the need for surgical cutting, liposuction, lasers and other more invasive cellulite fighters. All of this may sound familiar to patients who tried Kybella, only to be disappointed by its results. But Kybella was only for under-chin fat, Bloom points out, and CCH has already been proven to have fewer side effects. Currently in Phase 3 clinical trials, CCH could be on the market within a year.
Also coming soon: a new hyaluronic acid filler from South Korea. The new filler is about to enter FDA clinical trials. If approved, it could be in local physicians’ hands in a few years. At the forefront of cosmetic science, South Korea exported a slew of serums, devices and injectables in 2019. Not all of them came to the U.S.
“As a responsible physician, we don’t want to use something unless it’s been proven to work—and work better than what we already have,” Bloom says.