FDA approves treatment for metastatic cutaneous squamous cell carcinoma

Bloomberg News (9/28) reported the Food and Drug Administration approved Regeneron Pharmaceuticals Inc.’s and Sanofi’s Libtayo (cemiplimab-rwlc) for the treatment of “a deadly form of skin cancer.” The article points out that “it’s the first drug to come out of the companies’ 2015 partnership to research therapies that use the body’s immune system to fight various malignancies.”

Reuters (9/28, Babu) reported the Food and Drug Administration approved Sanofi SA’s and Regeneron Pharmaceuticals Inc.’s Libtayo (cemiplimab-rwlc) for the treatment of metastatic cutaneous squamous cell carcinoma “in patients whose condition has not improved following surgery or chemotherapy.” The article added that “metastatic cutaneous squamous cell carcinoma is the second-most common form of skin cancer, which accounts for an estimated 7,000 deaths in the United States each year.”

According to MedPage Today (9/28, Ingram), Richard Pazdur, M.D., the director of the FDA’s Oncology Center of Excellence, said in a statement, “This type of cancer can be difficult to treat effectively when it is advanced and it is important that we continue to bring new treatment options to patients.” Dr. Pazdur added, “We’re continuing to see a shift in oncology toward identifying and developing drugs aimed at a specific molecular target. With the Libtayo approval, the FDA has approved six immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway for treating a variety of tumors, from bladder to head and neck cancer, and now cutaneous squamous cell carcinoma.

GET YOUR FLU SHOT!

Nearly 80,000 died of flu last year, CDC says

The AP (9/26, Stobbe) reports about 80,000 Americans died of the flu and related complications this past winter – “the disease’s highest death toll in at least four decades” – according to CDC Director Robert Redfield, M.D. Dr. Redfield said, “I’d like to see more people get vaccinated. ... We lost 80,000 people last year to the flu.” Daniel Jernigan, M.D., “a CDC flu expert,” explained that while the flu detected this year appears to be a less aggressive strain, officials still “don’t know what’s going to happen, but we’re seeing more encouraging signs than we were early last year.” The AP adds that in recent years, “flu-related deaths have ranged from about 12,000 to – in the worst year – 56,000, according to the CDC.”

Fortune (9/26, Shoot) reports the flu vaccine “turned out to not be very effective” last year, which contributed to “the sudden increase in flu-related deaths.” After the last flu season, “the CDC began using a new methodology for ranking severity of flu seasons,” classifying the 2017-2018 winter as “a high severity season across all age groups,” the only season to receive a high severity classification.

Senate passes opioids package

Several outlets reported on the Senate’s passage of legislation to address the opioid epidemic. Colby Itkowitz writes in the Washington Post (9/17) that the Senate “overwhelmingly” passed a package of bills aimed at the nation’s opioid epidemic Monday by a 99 to 1 vote. The package includes 70 bills covering $8.4 billion in funding for programs across multiple agencies. The legislation requires the U.S. Postal Service to screen packages from overseas, typically China, for synthetic opioids and provides greater access to treatment.

The Wall Street Journal (9/17, Andrews, Subscription Publication) reports the package provides funding to the National Institutes of Health to research a nonaddictive pain medication. Another provision clarifies that the FDA has the authority to require prescriptions for opioids to be packaged in set amounts, such as three or seven days.

The AP (9/17, Fram) reports the package creates “new federal grants for treatment centers, training emergency workers and research on prevention methods.” The House passed its own package earlier this summer.

Afghan minorities seek plastic surgery to blend in with others

Cosmetic surgery has become more widely available in Kabul, Afghanistan, and many of surgeon Zalmai Khan Ahmadzai's patients are Hazara -- a long-persecuted religious and ethnic minority with Asian-like features -- who want to look more like other Afghans.

BEWARE OF SURGERY IN FOREIGN COUNTRIES - JUST BECAUSE IT'S CHEAP DOES NOT MEAN IT IS GOOD

Jane Park, 22, from Edinburgh, has described how she was left with searing pain all over her body after Turkish surgeons performed a "Brazilian bum-lift which involves the removal of fat from one part of the body to enlarge her bottom.
 She said: "They take fat from unwanted places and put it back into your bottom. When I woke up from surgery I was very cold and sore.

"I looked in the mirror and I was swollen from head to toe. I could barely open my eyes - it was horrible. It makes me feel sick looking at it.
 Park from Edinburgh suffered a drastic reaction when her bum-lift surgery ended with complications. (ITV)    
"I thought I was going to die, I didn't know what was wrong with me and they said it was a reaction to the local anaesthetic," she told the programme.
Jane became a social media celebrity after winning the Euromillions in 2017, and has since earned 43,000 Instagram followers who she keeps up-to-date with swimsuit photo shoots and glamour poses.
She added that she idolised celebrities on social media and that body image was very important to her before making the trip to Turkey in 2017 for the dramatic surgery.

She added: "I saw loads of celebrities on social media, there was your Kim Kardashians, and people in the UK who had had it done, and it seemed like an idea to lose weight. I had been looking at Instagrams of surgeons and clinics and researched the celebrities who all said it was fine."
But the American Society of Plastic Surgeons (ASPS) reported early this month that the procedure has the highest death rate for any kind cosmetic surgery.
Some 20,000 buttock augmentation procedures using fat grafting were performed in 2017, said ASPS. One in 3,000 people who undertook the bum-lift in the US died afterwards.

"Patient safety is the highest priority for board-certified plastic surgeons," said Dr Jeffrey Janis, President of ASPS. "The task force is concerned with the high mortality rate of this operation and is aggressively investigating ways to make this procedure safer. This new warning emphasises the continued risk that is being encountered with this procedure."
The risks are so great that Dr Gerard Lambe of the British Association of Aesthetic Plastic Surgeon (BAPS) told presenters Eamonn Holmes and Ruth Langsford he decided not to undertake similar procedures at his own practice.

Ms Park idolised celebrities who had undertaken the surgery and travelled to a clinic in Turkey where TOWIE stars Lauren Goodger and Amber Dowding, as well as Chloe Khan, from The X Factor and Celebrity Big Brother have both reportedly had surgery. (ITV)

He said: "We use (fat transfers) often to correct things in breasts, and it started in Brazil where you would take fat from other areas in this way. It would have been taken from the flank area, processed, washed and injected back in.

"People tend to want to go bigger and bigger, that's the trend - then you have to put the fat deeper. When you put the fat very deep into the muscle there are veins, and if the fat gets into those veins that's when you get very serious complications. Fat flies around the circulation, it can block the lungs, block the heart, and lead to very serious illness."
Ms Cambridge died after receiving bum lift surgery at the Elite Aftercare clinic in Izmir, according to reports. Her exact cause of her death is unknown.

Her partner Scott Franks said in tribute to the 29-year-old from Leeds:“How can this happen am I dreaming?”

“Two days ago I was happy. Now I’m a broken man and will be forever. I’m hurt so bad and this is only the start. My life has crashed," he wrote on social media on Tuesday.
A neighbour of Miss Cambridge told LeedsLive: She didn't need it, she didn't. She was a beautiful woman, absolutely stunning, and your heart goes out to those three little ones.
"Young people like her need telling, all these TV shows and celebrities are putting pressure on these girls to go out and have these expensive treatments."
The family are still waiting to return her body to the UK

MD Anderson Study of Silicone Implants Raises New Concerns
The largest ever study of silicone breast implants has found the devices are generally safe but associated with a slightly higher risk of a few rare diseases, a controversial conclusion that quickly reheated the seemingly settled issue.

The finding by MD Anderson Cancer Center researchers was disputed Friday by many experts, including federal health regulators, who have nevertheless scheduled a public meeting of medical advisers next year to consider implant safety. The study was based on the outcomes of nearly 100,000 patients who received one of the devices since they returned to the market in 2006.

“These findings aren’t meant to suggest implants caused these problems,” said Dr. Mark Clemens, an MD Anderson professor of plastic surgery and the senior investigator of the study. “They’re associations, which underscore the need for more research in this area, but do provide key safety information for women and their providers to consider when thinking about cosmetic or reconstructive surgery with breast implants.”

FDA: Avoid ‘energy-based’ vaginal treatment

For vaginal treatment, including cosmetic or for menopause or incontinence, the FDA recommends staying away from "energy devices" that include radiofrequency and laser. Treatment using energy-based therapies for the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse and recurring/chronic pain, the agency states.

BIA-ALCL Advisory Update The following advisory represents a collaborative effort between ASPS and ASAPS to produce biannual updates on recent disease developments, government regulatory communications, and consensus recommendations. Q: What is BIA-ALCL? A: BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma) is an uncommon lymphoma that has only been reported in patients with a history of a textured breast implant device. When caught early, it may be curable in most patients. BIA-ALCL is not a cancer of the breast tissue itself, but of the scar envelope that the body naturally forms around a breast implant – called the capsule. All government authorities and oncology organizations currently classify BIA-ALCL as a lymphoma.* However, BIA-ALCL consists of a spectrum of disease that ranges from indolent CD30+ fluid collections within the capsule, to capsular tumors, to lymph node involvement and rarely distant metastases. Ongoing research continues to strive to better understand and define BIA-ALCL.   *Lymph cells are part of the body's immune system that helps to protect and rid the body from noxious agents. A lymphoma is cancer of the lymph system. Lymph nodes are glands in many locations in the body that are part of the lymph system. Indolent refers to a cancer that is slow to progress. Q: What are the symptoms of BIA-ALCL? A: The most common presenting symptom of BIA-ALCL is a swelling of the breast that develops over several years (average 8 years, range 2 to 28 years) after the insertion of textured breast implants. The disease can also present as a lump in the breast or the lymph node in the armpit. Q: What is the risk of developing BIA-ALCL? A: In March 2018, the FDA issued a report stating that it has received 414 adverse event reports of BIA-ALCL, and nine disease-related death reports. However, the FDA warns this data may have duplicates and unverified cases. The ASPS/FDA PROFILE Registry reports 230 unique U.S. cases to date. For a frame of reference, both the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery report that approximately 300,000 breast augmentations and 150,000 breast reconstructions are performed annually in the United States. Approximately 12 percent of these patients receive textured implants. The lifetime risk of developing BIA-ALCL, from previous epidemiological studies and implant sales data from the U.S., Canada, Netherlands and Australia, ranges from 1:1000 to 1:30,000 people with textured implants. There appears to be some variability in risk depending on the type of texturing used on the implant. The risk is higher with textured implants that have greater surface area, such as the Biocell and polyurethane coating*, compared to those that have less surface areas. However, BIA-ALCL has been identified in patients with all types/brands of texturing. At this time there are no reported cases of a patient who has only had a smooth implant developing BIA-ALCL.   *Polyurethane sponge covered implants have not been available in the U.S. since the early 1990s. Q: What did the latest FDA statement say in regard to BIA-ALCL? A: The FDA's March 2018 statement recognizes BIA-ALCL is an uncommon and highly treatable condition and emphasized that most cases are in patients who have had textured implants. The FDA also acknowledged and agreed with the World Health Organization's classification of BIA-ALCL as a lymphoma, and the National Comprehensive Cancer Network (NCCN) treatment guidelines.* The FDA noted surgical management for the majority of patients, and recommends all confirmed BIA-ALCL cases be reported to the PROFILE registry for detailed tracking of cases. The statement also affirmed that if a breast implant patient is not experiencing symptoms then there "is no need to change your routine medical care and follow-up." In October 2017, the European Commission's Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) released a scientific advice report on BIA-ALCL where it stressed the importance of future research and reporting to prospective patient registries. In June 2018, the French regulatory body National Agency for Medicines and Health Products Safety (ANSM) released a report on biocompatibility testing of textured implants, and recommended no changes to current device approval. Both ASPS and ASAPS are funding research focused on determining the cause of this cancer and finding a solution to the disease.   *The National Comprehensive Cancer Network (NCCN) is an alliance of 27 cancer centers in the United States which establishes consensus diagnosis and treatment recommendations for the majority of known cancers. NCCN established evidence-based guidelines for BIA-ALCL in 2016, which are updated annually. Q: What is the significance of the latest FDA statement? A: The FDA statement emphasized that this disease was predominantly associated with textured implants. The FDA acknowledged and agreed with the World Health Organization classification of BIA-ALCL as a lymphoma and treatment guidelines established by the National Comprehensive Cancer Network (NCCN). Both ASPS and ASAPS fund research to ascertain what might be the underlying issues causing this cancer, and to try to find a solution so that the disease may be eradicated. Q: Is BIA-ALCL a major concern? A: All patients should be advised of the risk of BIA-ALCL. Although the incidence is uncommon, any procedure that may lead to the death of a patient must be considered a major concern, and patients should be made aware of it prior to undergoing breast implant surgery. As of July 30, 2018, the PROFILE registry* has received 230 unique cases of BIA-ALCL in the U.S.: 56 percent had a history of cosmetic breast augmentation; 44 percent had a history of post-mastectomy reconstruction. Worldwide, 570 unique cases have been reported, which includes 16 disease-related deaths. ASAPS and ASPS provide online patient education tools that help breast implant patients put this disease in perspective. The relative risk of capsular contracture versus BIA-ALCL is approximately 100 to 3000 times higher in any given patient. Though the risk is small, patient safety is the primary focus of the plastic surgery community, and we strive to educate and inform our members and the public about the symptoms and risk of BIA-ALCL.   *The National Comprehensive Cancer Network (NCCN) is an alliance of 27 cancer centers in the United States which establishes consensus diagnosis and treatment recommendations for the majority of known cancers. NCCN established evidence-based guidelines for BIA-ALCL in 2016, which are updated annually. Q: Can you explain the differences in implant texture and what role that factor plays in the research? A: Although it is uncommon, BIA-ALCL appears to develop exclusively in women who have or have had textured implants. There is a higher incidence of BIA-ALCL in higher surface area/roughness devices. To date, there has not been a documented case of BIA-ALCL in a patient with only smooth implants. Suggested theories of the cause of BIA-ALCL include textured implant particulate, chronic allergic inflammation, and/or response to a biofilm. Research is ongoing in all these areas. In both the US and the worldwide reported cases of BIA-ALCL, there does not appear to be a difference in risk in silicone versus saline-filled implants, nor between reconstructive or cosmetic use of breast implants. Q: How does this impact those with breast implants? A: ASPS, ASAPS and the FDA advocate that all women, including those with breast implants follow their normal routine medical care and follow up, including mammography when appropriate. Patients should immediately contact their physician if they sense any abnormalities within the breast or notice any significant changes. There is no recommended BIA-ALCL screening for patients without symptoms. Fluid collections around implants within the implant capsules can occur and are usually not malignant. However, if the fluid collection around the implant is present one year or more after implantation, it should be considered suspicious and MUST be aspirated and the fluid tested with CD30* immunohistochemistry and cytology.   *CD30 refers to a cell membrane protein that occurs normally on activated T-cell lymphocytes and abnormally in some lymphomas. CD30 immunohistochemistry is the screening test for BIA-ALCL and should be performed on all fluid collections developing more than one year after implantation. If CD30 is negative, BIA-ALCL is excluded. If CD30 is positive, it may or may not be BIA-ALCL and cell block cytology and flow cytometry are required to make the diagnosis. Q: What about those considering breast implants? A: Physicians should include BIA-ALCL in breast-implant patient education materials and during the informed consent process, so that patients can determine the right procedure for them. Breast implants have established as well as ongoing long-term safety data available – and the incidence of BIA-ALCL is low. Q: How is BIA-ALCL treated and what is the prognosis? A: Diagnosis and treatment follow standardized guidelines established by the National Comprehensive Cancer Network (NCCN). (Algorithm available on ASPS and ASAPS websites). Current recommendations for the treatment of BIA-ALCL call for total capsulectomy, removal of the breast implant, as well as excision of any associated lumps or masses. Cases have been reported where both breasts are affected, and therefore surgeons may consider removing both implants and capsules. All cases of BIA-ALCL with disease limited to the scar tissue around the breast capsule and treated with complete surgical excision have been cured to date. The majority of early-stage patients treated with total capsulectomy require no additional treatment. Chemotherapy is required for unresectable disease, lymph node spread or distant metastases. Q: Are some patients at greater risk than others? A: It is not possible to predict who will develop BIA-ALCL. It has occurred in women who have a history of textured breast implants for both cosmetic and reconstructive purposes and has occurred in women with both saline and silicone implants. The following are the current risk factors for BIA-ALCL based on published data and research: 1. Device. Textured surface devices. There have been no reported cases in patients with only smooth-walled implants. 2. Genetics. There have been two published reports that there may be a genetic predisposition (germ line mutations in JAK1 and STAT3 genes). Further investigation is required. 3. Inflammation. Chronic inflammation triggered by an allergic response, bacteria, another as yet unknown factor, or some combination has been implicated. 4. Time. BIA-ALCL typically presents several years (average 8 years, range 2-28 years) after the implants were placed. Q: Should healthy patients have their implants removed prophylactically? A: The FDA does not suggest additional screening or removal of implants for women that are not having symptoms. Q: Should women with breast implants be screened for BIA-ALCL? A: The FDA advises that women without breast changes do not require more than routine follow-up. If a patient experiences a change in her breasts – especially if there is swelling or a lump – she should see her surgeon and undergo examination, imaging, and fluid testing if present. Q: What causes BIA-ALCL? A: The ASPS, PSF, ASAPS, ASERF and the FDA are studying BIA-ALCL.* Bacterial contamination, long-term allergic inflammation and/or irritation from implant texturing, and genetic factors have been theorized and are undergoing further study. Research is ongoing and cases are being monitored. Concentrations of reported cases vary widely across the globe, with some geographic areas reporting very few cases. Ongoing data collection worldwide will help to determine any genetic propensities for this disease.   *American Society of Plastic Surgeons (ASPS), The Plastic Surgery Foundation (PSF), American Society for Aesthetic Plastic Surgery (ASAPS), The Aesthetic Surgery Education and Research Foundation (ASERF), United States Food and Drug Administration (FDA). Q: Does the FDA recommend against the use of textured implants? A: The FDA confirms that all breast implants carry a reasonable assurance of safety when used as indicated. Best practice requires plastic surgeons to discuss the known risks and potential complications associated with any procedure. It is important for the patient and her surgeon to frankly discuss all treatment options available, along with the risks that include BIA-ALCL, capsular contracture, implant malposition, and rates of reoperation. The plastic surgeon must provide a frank and transparent discussion regarding the benefits and risks of implants, both smooth and textured. The patient must then make an informed decision, based upon her own assessment of her needs and the risks involved. If the surgeon's evaluation deems equivalent results from both a smooth or textured implant, the use of a smooth implant may prove prudent. Q: Have there been any deaths due to BIA-ALCL? A: There have been 16 confirmed deaths globally, which includes 5 U.S. cases, attributed to BIA-ALCL to date. Disease-related deaths have been reported in Australia, Brazil, France, Netherlands, New Zealand, Sweden, United Kingdom and the United States. In the 16 known deaths from the disease, all patients either received chemotherapy/XRT alone, died of the treatment itself, had incomplete capsule removal, or disease spread prior to treatment (metastatic disease). These reports emphasize the importance of disease recognition and proper treatment in a timely fashion. Q: What is the recommended clinical response to a patient presenting with symptoms that could be attributable to BIA-ALCL? A: Diagnosis of BIA-ALCL follows international recommendations by the National Comprehensive Cancer Network (NCCN).* Following NCCN guidelines, a swollen breast can be evaluated with ultrasound for either a fluid collection, capsular mass, or lymph node swelling. Fluid collections should be sampled with a needle through the skin (aspirated percutaneously). A minimum 20ml and ideally as much fluid available should be sent for: 1. CD30 immunohistochemistry 2. Cell block cytology and flow cytometry evaluation and labelled to "rule out BIA-ALCL."   CD30 testing is critical to direct pathologists and help establish a diagnosis prior to any surgical intervention. CD30 testing is critical to direct pathologists and efforts should be made to establish a diagnosis prior to any surgical intervention.   *In July 2016, ASPS and ASAPS issued a joint "Tear Sheet" describing the recommended clinical treatment for patients presenting with symptoms that could be a sign of BIA-ALCL which ultimately was the framework for NCCN guidelines. For a copy of the ASPS/ASAPS Tear Sheet please go to: Joint-ASPS-ASAPS Statement on Breast Implant-Associated ALCL. The document can also be accessed on the ASAPS website at: http://www.surgery.org/professionals. Q: How is BIA-ALCL diagnosed? A: Diagnosis should be made by fluid sampling (aspiration) in a clinic or by interventional radiology prior to any surgical intervention. Diagnosis requires very specific findings: large anaplastic cells on cytology, CD30+ immunohistochemistry, and clonal expansion on flow cytometry. Mammography is not useful in diagnosing BIA-ALCL. In confirmed cases, PET and CT scanning is performed to help stage the disease, evaluate for associated capsule masses, lymph node metastasis or organ metastasis. Once the diagnosis is confirmed, oncologic consultation should be obtained prior to any surgical intervention. Q: Should patients that have textured implants in place be contacted about the risk of BIA-ALCL? A: Physicians can provide preoperative disclosure and maintain adequate patient records and operative reports. Patient education resources are available to surgeon members from ASPS* and ASAPS**.   *Available at www.plasticsurgery.org/alcl or **www.surgery.org/professionals Q: Should patients with implants in place be followed on a routine basis, i.e., annually? A: There are no current screening recommendations for BIA- ALCL. The FDA recommends patients be screened post-operatively with MRI to diagnose implant rupture but this may or may not detect BIA-ALCL. Periodic clinical examination for implant patients is recommended, as one would do to screen for implant complications such as capsular contracture. Patients should also undergo age-appropriate breast cancer screening with mammography and be encouraged to perform monthly self-examination. Q: Where can I find more information on BIA-ALCL? A: Additional information, downloadable manuscripts, and resources on BIA-ALCL are available online at www.thepsf.org/PROFILE and at www.plasticsurgery.org/alcl, and in the Medical Professionals section of www.surgery.org as well as by searching "ALCL" on RADAR. Reporters seeking information or plastic surgeons contacted by a member of the media are encouraged to forward inquiries to: • Adam Ross at aross@plasticsurgery.org or 847-228-3361. • Leigh Hope Fountain at leigh@surgery.org or Sarah Lilburn at sarah@surgery.org or 562-799-2356. This information represents the data known as of July 30, 2018. Updates to this document will be provided as warranted and as more information is known. Contribute to the ASPS Blog » If you are an ASPS member surgeon, we invite you to become a blog contributor and advance our patient education mission. The American Society of Plastic Surgeons 444 E. Algonquin Rd. Arlington Heights, IL 60005 (847) 228-9900 This message was intnded for: bradgarber@sbcglobal.net You were added to the system June 30, 2011 For more information click here. Update your preferences

 

CDC: Drug overdoses killed 72,000 in 2017

In a front-page story, the New York Times (8/15, A1, Sanger-Katz) reports that drug overdoses killed more than 72,000 Americans in 2017, a rise of about 10 percent from the year prior, according to new preliminary estimates from the Centers for Disease Control. The rising death toll “reflects two major factors: A growing number of Americans are using opioids, and those drugs are becoming more deadly.” Experts who are monitoring the epidemic point to the increase in synthetic opioids like fentanyl “most likely explains the bulk of the increased number of overdoses last year.” According to the CDC estimates, “overdose deaths involving synthetic opioids rose sharply, while deaths from heroin, prescription opioid pills and methadone fell.”

YouTube not a reliable resource for plastic surgery info

An analysis using keyword searches on YouTube for popular facial plastic surgery procedures revealed that many videos were part of marketing campaigns posted by non-qualified medical professionals, researchers reported in JAMA Facial Plastic Surgery. Many of the most-viewed videos contained biased information, lacked balanced information regarding risks and benefits and offered potentially misleading information about the practitioner's qualifications, and even some posted by board-certified surgeons were marketing tools designed to look like educational videos, the researchers found.