Saturday, August 18, 2018

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.
ASPS Blog
 

 
 

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.

Saturday, April 1, 2017

DO YOUR HOMEWORK BEFORE CHOOSING COSMETIC SURGERY


Fake cosmetic surgeon sentenced to prison for manslaughter
A judge sentenced a bogus Florida cosmetic surgeon to 10 years in prison and five years of probation for allegedly injecting clients with a mixture of cement, mineral oil, bathroom caulk and tire sealant. The defendant, Oneal Ron Morris, did not contest the charges of manslaughter and practicing medicine without a license, but denied injecting the lethal combination into clients, at least one of whom died.


A salon worker in Dallas could be sentenced to life in prison after a jury found her guilty of murder and practicing medicine without a license. Prosecutors say a salon client died after the defendant injected the client's buttocks with industrial-grade silicone in a procedure the salon offered as a "Wee Wee Booty."
 
 

Tuesday, March 28, 2017

SKIN CARE

The American Skin Association launches its Seven Principles for a Lifetime of Healthy Skin, part of a worldwide educational effort to increase understanding of the importance of skin and the assurance of its health throughout one’s lifetime.
The principles are as follows:
  1. Minimize exposure to UV light. Limit time outdoors between 10 am and 4 pm, apply broad spectrum sunscreen daily, wear sun protective clothing, and avoid tanning beds and similar artificial tanning devices entirely.
  2. Maintain a healthy lifestyle that includes regular water intake, sleep and exercise. Do not smoke.
  3. Visit your dermatologist once a year or as needed.
  4. Examine your skin daily, and report concerning changes in skin condition and/or color to your dermatologist or Health Care Professional as soon as possible.
  5. Hydrate your skin daily, especially after bathing or showering.
  6. Maintain good hygiene for skin, hair and nails by giving gentle and constant attention to avoid irritation.
  7. Immediately attend to wounds. To avoid infection and scarring, never pick or squeeze blemishes.
These principles were developed as the result of input from more than 800 respondents (dermatologists, family practitioners, and pediatricians) to a survey, compiled by the American Skin Association and Derm101, regarding the most important tips for a lifetime of healthy skin. A consensus of members of the ASA Education Council also contributed to the principles, according to a media release from the American Skin Association.
The Seven Principles provide guidance for today’s young as well as address the more acute needs of today’s old,” says Dr Jeannette Jakus of SUNY Downstate Medical Center, in the release. “Nearly half of all primary care visits are due to skin disorders, and this burden grows significantly as we age. The Seven Principles are tools that everyone can use, at every stage of life, that will improve our quality of life today and as we age, and reduce healthcare costs for years to come.”
The educational effort begins with the inclusion of skin health in the World Health Organization’s new Health and Aging Strategy, which explains that skin diseases — including skin cancers —not only have a significant effect on quality of life, they can lead to additional health issues in both children and adults, per the release.
“Our skin is our largest organ and protects us from harmful bacteria, pollution, and toxins in the environment,” explains Dr Jean L. Bolognia, professor of dermatology at Yale School of Medicine. “As we age, those defenses weaken, making us more susceptible to infection, pain, and hospitalization. The need to establish skin healthy behaviors and protect our skin throughout our lives is more critical today than ever before.”
“A child born today will live to be 100 years old,” adds Dr David A. Norris, chair of the Department of Dermatology at the University of Colorado School of Medicine and the newly elected president of the ASA, in the release. “Our expected 21st century longevity creates a whole new set of imperatives for how we treat our skin to ensure that it lasts for 100 years or more.”
[Source(s): American Skin Association, PR Newswire]

ANAPLASTIC LARGE CELL LYMPHOMA AND BREAST IMPLANTS

The Food and Drug Administration says at least nine women have died of a rare blood cancer after receiving breast implants, and that the agency is officially acknowledging an association between the implants and the disease.
On Tuesday, the agency announced that as of Feb. 1, it had received 359 breast implant-associated reports of a rare type of non-Hodgkin’s lymphoma called anaplastic large cell lymphoma, or ALCL.
The cancers were more common in women who had implants with textured, rather than smooth, surfaces.
About 290,000 people received breast implants in the U.S. last year, according to the American Society of Plastic Surgeons, which does not track the surface textures of implants in its yearly reports.
Of the 359 cases reported to the FDA, 231 had information on the types of implants. Of those, 28 of the cancers were in women who received breast implants with smooth surfaces and 203 were in women who had a version with a textured surface.
It is still unclear whether the texturing is actually responsible for the cancer, or is just associated with a higher incidence of the disease

MERKEL CELL CARCINOMA

The US Food and Drug Administration has granted accelerated approval for Bavencio (avenulab), a treatment for a rare and aggressive form of skin cancer called metastatic Merkel cell carcinoma (MCC).
Approximately 1,600 people in the United States are diagnosed with MCC every year, and more than 30% of them will eventually develop metastatic disease, in which the cancer has spread beyond the skin into other parts of the body. Fewer than half of the patients with this disease will survive more than 1 year, and fewer than 20% will survive beyond 5 years, according to the National Cancer Institute in a media release from the FDA.
Bavencio is a human anti-PD-L1 antibody that is formulated to target the PD-1/PD-L1 pathway and help the body’s immune system attack cancer cells.
The treatment was developed, reviewed, and approved through the FDA’s Priority Review and Breakthrough Therapy programs. It also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. In addition, it received an Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients.
“While skin cancer is one of the most common cancers, patients with a rare form called Merkel cell cancer have not had an approved treatment option until now,” said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence, in the release.
The approval of Bavencio was based on data from a trial of 88 patients with metastatic MCC who had been previously treated with at least one prior chemotherapy regimen. The trial measured the percentage of patients who experienced complete or partial shrinkage of their tumors (overall response rate) and, for patients with a response, the length of time the tumor was controlled (duration of response).
Of the 88 patients who received Bavencio in the trial, 33% experienced complete or partial shrinkage of their tumors. The response lasted for more than 6 months in 86% of responding patients and more than 12 months in 45% of responding patients, the release continues.
EMD Serono—the biopharmaceutical business of Merck in the United States and Canada—and Pfizer will commercialize the treatment, the release notes.
[Source(s): US Food and Drug Administration, PR Newswire]