The survey was sent to 2,553 plastic surgeons across 22 countries and focused on understanding the impacts to the specialty from non-physicians and/or physicians across the globe who did not train in plastic surgery but perform plastic surgery procedures. Respondents were further asked to provide input on how such practices affect patient safety worldwide. 

The survey’s objectives also sought to identify knowledge of and implications for regulatory agencies in determining the scope of practice for physicians and nonphysicians in each country.

Key findings from the survey include:

• Most countries have a regulatory entity, but some face regulations that vary by region or lack a regulatory agency entirely.
• Responses were mixed on whether the regulatory entities in their country specifically govern professional titles or advertising.
• Many respondents stated they believe there are no restrictions for noncertified plastic surgeons performing cosmetic surgery in their location.
• Most respondents have the opinion that injectables should be restricted to trained physicians and view fillers and neurotoxins as cosmetic medical treatments.

The results also underscore a widespread issue of patients consulting trained plastic surgeons after undergoing procedures by under-trained or non-medical professionals. Many note patients present with additional complications or harm resulting from procedures performed by undertrained or non-medical professionals in their country.

Regarding advertising, responses indicated challenges plastic surgeons face in differentiating themselves from uncertified counterparts. Although these plastic surgeons indicate they use credentials and accreditations in social media messaging, the high-volume use of social media by untrained professionals and influencers continues to blur these lines in the patient audience worldwide.

ASPS officials say they remain dedicated to upholding high standards in plastic surgery nationally and internationally and investing in the education and safety of patients around the globe.

ESPRAS, which represents national associations in plastic surgery across Europe, ensures that all its member plastic surgeons have undergone advanced multi-year training in plastic surgery. However, it points out that in most European countries, laws do not prohibit medical doctors without specialization, and in some cases, even paramedics, from referring to themselves as “aesthetic surgeons” or “beauty doctors.”

Riccardo Giunta, ESPRAS President and consultant plastic surgeon in Munich, Germany, underscores the potential risk to patient safety. “The financial allure of both aesthetic surgery and non-surgical aesthetics attracts many individuals,” he says, adding that the public is generally uninformed about the standard of care in training.

Giunta further warns that patients might believe that professionals with these titles have the appropriate qualifications to ensure safety, but this might not be the case. “They may not have passed the standards of a board-certified plastic surgeon and lack essential knowledge,” he explains, suggesting that unregulated commercial organizations could contribute to this problem.

ESPRAS recently conducted a survey across 23 European countries to assess levels of education and specialization in plastic surgery. The results highlighted the high level of training required for board certification, underscoring the potential risks of opting for a practitioner who is not trained to this standard.

In its position paper, ESPRAS calls for patient safety to take precedence over financial gain. It is working to support national legislation that would provide clear regulation of aesthetic surgery across Europe, and is urging the public to be aware of the dangers of under-trained practitioners.

The new regulation aims to create ‘a robust, transparent, and sustainable regulatory framework, recognized internationally, that improves clinical safety and creates fair market access for manufacturers’ and is widely viewed to be a more thorough and stringent regulation process in comparison to its predecessor, the Medical Device Directive (MDD).  

Over the course of the past year, Neauvia compiled and submitted all the required technical and clinical documentation for its facial dermal fillers which was assessed and subsequently approved by a European Union notified body. 

Gabriele Drigo, Neauvia’s founder & CEO, said, “The MDR was created with the goal of enhancing overall transparency, creating better access to information on medical products for both the public and healthcare professionals. Due to the dedication and hard work of the team, we are now able to confirm that our facial dermal fillers have successfully passed this rigorous process which should give the medical community and our customers the utmost confidence when using facial dermal fillers products recognized by MDR.” 

The news of Neauvia’s CE marking under the EU’s new MDR for its facial dermal fillers comes as the company recently opened a new international training center in Dubai and the unveiling of new clinical research at this year’s IMCAS with further developments expected throughout 2023. 

The final guidance—Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C—from the FDA describes steps companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled product is on the market and, thus, limit the public’s exposure to risk. 

“Voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe,” says Associate Commissioner of Regulatory Affairs Judith McMeekin, Pharm. D. “It is critical that all companies in the supply chain are ‘recall ready’ to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain.”   

A voluntary recall is an action taken by a company to correct a violative product or remove it from the market. A recalling company may act on its own initiative or the FDA may inform the company that a distributed product violates the law and recommend the company recall the product. The FDA has the authority to require recalls of certain products in particular circumstances, such as controlled substances, biological products, human cells, tissues and cellular and tissue-based products, medical devices, and foods. 

The final guidance explains how companies should have adequate product coding and maintain distribution records to facilitate faster, more accurate recall actions, which the FDA recommends that all companies do.

The guidance also urges companies to act quickly to initiate a recall when public health is at risk and to do so prior to completing an investigation into the cause of the problem. Because recalls can affect the entire supply chain, including downstream suppliers, wholesalers or vendors, the FDA recommends that companies develop recall procedures to quickly inform their entire distribution chain, so consignees can rapidly identify affected lots and recall downstream products when necessary. 

The government notes that the majority of the aesthetics industry shows good practice when it comes to patient safety. However, it sees this legislation as a way to ensure consistent standards and protect individuals from those without licenses. 

“While most of those in the aesthetics industry follow good practice when it comes to patient safety, far too many people have been left emotionally and physically scarred after botched cosmetic procedures,” said Health and Social Care Secretary Sajid Javid. “I am committed to protecting patient safety by making it an offense for someone to perform these cosmetic procedures without a license.”

Minister for Patient Safety Maria Caulfield added, “The spread of images on social media has contributed to an increase in demand for cosmetic procedures such as Botox and fillers. While these can be administered safely, we are seeing an unacceptable rise in people being left physically and mentally scarred from poorly performed procedures. Today’s amendment is the next step on the road to effective regulation of non-surgical cosmetic procedures in England.”

This latest legislation comes on the heels of the Botulinum Toxin and Cosmetic Fillers (Children) Act, which came into effect in October. That law prohibits people under 18 years of age in England from receiving Botox and dermal lip fillers for cosmetic reasons and applies to those visiting from outside England and those who have permission from someone over age 18. Treatments can still be approved by a medical practitioner for those with clinical need. 

In addition, England banned adverts on all forms of media, including social media, influence advertising, and traditional advertising for cosmetic procedures which target those under 18. 

Photo 145548810 © Artem Medvediev | Dreamstime.com

The US Food and Drug Administration (FDA) [recently] finalized guidance explaining when it considers microneedling devices to be medical devices subject to premarket notification (510(k)) requirements.
 
The final guidance, which comes more than three years after being released in draft form, has been revised to reflect the classification of microneedling devices for aesthetic use as Class II devices in response to a De Novo classification request for Bellus Medical’s SkinPen. Since issuing the classification order, FDA has cleared several other microneedling devices including Esthetic Education’s Skinstylus Sterilock Microsystem and Refine USA’s Rejuvapen NXT. 

Read the full article at www.raps.org

The group’s first action is to work with Congress to stop planned cuts to Medicare payments that would hurt patients, it notes in a media release. 

The cuts, planned by the Centers for Medicare & Medicaid Services (CMS), are set to take place in January 2021 and reduce payments for surgical care. These cuts could force surgeons to see fewer Medicare patients, which would lead to reduced access to care for older Americans and lower their quality of life.

To preserve care for patients, the coalition wants Congress to waive Medicare’s budget neutrality requirements to prevent the cuts. This will ensure Medicare patients continue to have the best access—to the best care—when they need it and where they need it.

The Surgical Care Coalition commissioned a survey of more than 5,000 surgeons, which found that surgeons are facing serious financial distress due to the COVID-19 pandemic. While the cuts were announced before the pandemic, with the combined impact of the planned CMS cuts and the financial distress due to COVID-19, surgeons and hospitals will face difficult decisions to keep surgical practices afloat. In addition to other findings, the survey found that even before the CMS cuts:

• One-in-three private practice surgeons are concerned they will have to shut down, limiting choice and access.
• Nearly half of surgeons face more difficult financial decisions and are responding by either cutting their own pay or by paying employees in the face of declining revenues.

“These cuts presented a difficult future for surgical patients, even before COVID-19 hit. If they go into effect while the country is dealing with the consequences of the pandemic, American patients will pay an even greater, devastating cost. Surgeons play a key role in America’s health care system, which is already under strain from COVID-19. The Surgical Care Coalition is against these cuts because they will ultimately hurt the patients we care for every day.”

— David B. Hoyt, MD, FACS, American College of Surgeons Executive Director

About the Surgical Care Coalition

The Surgical Care Coalition advocates for access to quality surgical care for all Americans, the release continues.

The Surgical Care Coalition is comprised of 12 surgical professional associations that represent more than 150,000 surgeons working across the country with a common goal of improving the quality of care, and quality of life, for all patients. The founding members have met and informally worked together for nearly 3 decades to promote sound policy solutions to the U.S. Congress and federal regulatory agencies to solve the biggest challenges in health care.

Founding members of the Surgical Care Coalition:

• American Academy of Ophthalmology
• American Association of Neurological Surgeons
• American College of Osteopathic Surgeons
• American College of Surgeons
• American Society for Surgery of the Hand
• American Society of Colon and Rectal Surgeons
• American Society of Plastic Surgeons
• Congress of Neurological Surgeons
• Society for Vascular Surgery
• Society of American Gastrointestinal and Endoscopic Surgeons
• The American Society of Breast Surgeons
• The Society of Thoracic Surgeons

[Source(s): Surgical Care Coalition, PR Newswire]

The agency issued a warning letter to Irvine, Calif-based breast implant manufacturer Allergan for failing to comply with requirements—under two separate premarket approval orders—to conduct post-approval studies to assess the long-term safety and risks of two models of breast implants, both of which were voluntarily recalled from the market last year.

The FDA also issued a warning letter to Dallas-based Ideal Implant Inc for failure to comply with current good manufacturing practice requirements and adverse event reporting requirements following an inspection conducted in early 2020.

Allergan Warning Letter

Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate the safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer. Generally, a manufacturer must still comply with post-approval requirements even if a breast implant has been voluntarily recalled from the market, in part, to continue assessing long-term outcomes in patients who are already implanted with these devices.

“The FDA imposes post-approval requirements because they are an important tool for ensuring the safety and effectiveness of the medical devices we regulate,” says Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, in a media release.

“The agency has been diligently tracking post-approval studies as part of our ongoing efforts to evaluate, understand and provide updates to the public on breast implant safety and risks. Post-approval studies are especially important to inform our understanding of the long-term potential risks associated with Allergan’s implants, including the models that have since been recalled from the market due to increased risk of breast implant associated anaplastic large cell lymphoma. The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable. The FDA will continue to hold manufacturers accountable if they fail to fulfill their obligations.”

The FDA’s warning letter to Allergan noted several serious deficiencies in the manufacturer’s post-approval study to evaluate its NATRELLE Silicone Gel-Filled Breast Implants (“Round Responsive implants”) and its NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (“Style 410 implants”). The post-approval study group of subjects with Round Responsive implants has shown poor recruitment and follow-up rates. Allergan’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s premarket approval order.

The FDA requested a response from Allergan within 15 working days of issuance of the warning letter and asked Allergan to provide details about how the company will correct the violations. Failure to promptly comply with post-approval requirements may result in additional action.

Ideal Implant Inc Warning Letter

Manufacturers must also adhere to quality system regulations, which includes compliance with applicable current good manufacturing practice requirements. Further, under the Medical Device Reporting (MDR) regulation, manufacturers must report certain device-related adverse events and product problems to the FDA—one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

“Quality system inspections are a way for the FDA to determine if a manufacturer’s activities and procedures, conducted during and after the manufacturing of a device, comply with applicable regulations. When these regulations are followed, it results in safer products for patients,” Ashar adds, in the release.

“While inspecting the Ideal Inc facility in January and February, FDA inspectors observed potential violations of the Federal Food, Drug, and Cosmetic Act. Although Ideal Implant Inc responded to the FDA Form 483-List of Inspectional observations provided to the company at the end of the inspection, most of the corrective actions they took were not adequate. To protect patients, the company should now take additional action to make sure these issues are properly addressed. Addressing quality system and medical device reporting violations helps ensure patient safety, which is our top priority.”

The warning letter issued to Ideal Implant Inc revealed the Ideal saline-filled breast implants were adulterated due to a failure to maintain proper files for device complaints the manufacturer received from customers, failure to establish and maintain appropriate procedures for implementing corrective and preventive actions and failure to establish and maintain adequate criteria for testing finished devices. The FDA’s warning letter requests that, in a response to the agency, Ideal Implant Inc more adequately describe and clarify details about device complaints, including what happens when a customer cancels a complaint. The FDA also requests that the firm clarify how it tests a finished product to ensure it meets specifications.

The FDA’s inspection also revealed the products were misbranded because the firm failed to provide timely reports of device malfunctions to the FDA that could result in death or serious injury.

The FDA requested a response from Ideal Implant Inc within 15 working days of issuance of the warning letter with details about how the company will correct the violations. Failure to address the violations identified within the Warning Letter could result in enforcement action, such as seizure, injunction and civil money penalties.

The FDA’s actions are part of the agency’s ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. As part of the Medical Device Safety Action Plan, the FDA is committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues in a more timely and effective manner, including taking action against manufacturers when their postmarket studies are non-compliant with study requirements.

The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements. For example, the FDA issued warning letters to Mentor Worldwide LLC of Irvine, Calif, and Sientra Inc of Santa Barbara, Calif, in March 2019. Those warning letters and the letters sent to Allergan and Ideal Implant Inc reflect the agency’s continued commitment to act against manufacturers who fail to comply with post-approval requirements.

In addition to the required post-approval studies, the FDA has taken additional steps in the last several years to ensure the agency is monitoring the safety and risks of breast implants. For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology, or PROFILE, which collects real world data regarding patients who have a diagnosis of Breast Implant Associated ALCL (BIA-ALCL). The data collected from this registry have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL.

Additionally, the FDA worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry to provide a platform for collecting additional real world data on the safety and performance of breast implants. This registry will add to the information the FDA collects in post-approval studies about the long-term safety of breast implants, and potentially enhance the understanding of the long-term safety and risks associated with breast implants.

The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness.

Health care professionals and consumers should report any adverse events related to breast implants to the FDA’s Adverse Event Reporting program. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

[Source: US Food and Drug Administration]

Members of the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) are facial plastic surgeons, board certified, and trained experts on the face and neck. They offer front line perspectives to block the spread of the virus with tips for keeping the mouth, nose and eyes healthy. The COVID-19 viral particle is both infectious by aerosolization and by being present on surfaces. The germs become infectious by the particles entering the body by the mouth, nose or eyes.

While scientists work on a vaccine, the following tips should be followed:

Masks: This virus can be transmitted by people who aren’t showing symptoms. So, covering the nose and mouth to prevent spread from an asymptomatic infected person is important. Also, a mask protects the mask wearer from others who are contagious.

“It is important to wear masks correctly,” says Theda Kontis, MD, a facial plastic surgeon and AAFPRS board member. “They should cover the nose and mouth; sanitize hands before and after placement of the mask. Also masks can be irritating to our skin, can cause friction injuries and increases acne, rosacea, and other skin conditions. We encourage washing the face well with warm water and antibacterial soap and pat dry. Apply a dimethicone-containing product to protect the skin and use a moisturizer about 30 minutes before applying a mask.”

Hand Washing: Washing or sanitizing the hands frequently is important so people don’t get the viral particles on hands and then infect themselves by touching their eyes, nose or mouth. Don’t’ forget cell phones—they are dirty. Clean them as often as you clean your hands (either with a UV light sterilizer, or alcohol-based sanitizer).

Eye Protection: Medical professionals wear eye protection when less than 3 feet from patients. Social distancing of 6 feet probably does not require eye protection from aerosolized viral particles. However, rubbing your eyes with infected hands will probably result in COVID infection. Keep hands off the face and mouth and sanitize hands and disinfect surfaces frequently.

Gloves: Kontis doesn’t recommend that the general public wear gloves. “Most people think of gloves as a means to keep hands clean. Medical professionals use gloves to do one task then throw the gloves away. I see so many people now wearing winter or medical gloves, who are touching potentially infected surfaces, then touching their face, cell phone, steering wheel, etc. Gloves can make the situation WORSE by spreading infection.”

There can be rare exceptions of course, but by and large protecting yourself from contracting this disease really comes down to simple measures. “You’ve got to develop a strategy to prevent the virus from moving from your hands to your mouth, nose or eyes. This is how the vast majority of infections are likely acquired. When you venture out of your house, be prepared. Give yourself a pep talk,” says facial plastic surgeon Patrick Byrne, MD, AAFPRS board member.  “You are going to be careful. The mask is key because it serves as a reminder not to touch your face. Consciously reminding yourself about your hands is something you cannot do too frequently. What must you touch? Can you avoid touching much?  How can you make sure you wash your hands frequently, especially prior to touching your face?” 

Today’s new normal is very different because of COVID-19. Practicing these simple Coronavirus safety tips when going out in public will help protect you especially as more states begin reopening.

[Kelz Media]

BRUSSELS (Reuters) – Victims of defective breast implants made by French company Poly Implant Prothese (PIP) may only get compensation if they had the procedure in France, an adviser at Europe’s top court said on Thursday, in a potential blow to thousands of women worldwide.

The opinion by Advocate General Michal Bobek at the Court of Justice of the European Union (CJEU) came after a German patient sought compensation from PIP’s French insurer Allianz IARD in a German court for faulty breast implants.

The PIP scandal, which emerged in 2010, affected about 300,000 women in some 65 countries worldwide. The company filled its implants with unauthorized industrial silicone instead of medical silicone. It shut down in 2010.

“The civil liability insurance of breast implant producer PIP could validly be limited to women who underwent surgery in France,” Advocate General Michal Bobek said in his non-binding opinion on Thursday.

Bobek said that it was for EU countries to regulate insurance policies relating to medical devices used on their territory even if they were imported from another member state.

PIP founder Jean-Claude Mas was jailed for four years and fined 75,000 euros ($82,522.50) in 2013 after a police investigation revealed a sophisticated fraud.

The court, which will issue its ruling in the coming months, usually follows the opinions of its advisers in four out of five cases.

[Source: Reuters Health]