Double-sided “Eve”

The application of botulinum toxin in the field of medical beauty has been the clinical push for “instructions”

No one can reject beauty.

Driven by the United States, in 2017, more than 5 million people worldwide were injected with botulinum toxin. The number of beauty seekers in China has also continued to rise, and they have traveled through medical institutions, beauty salons, and even mobile beauty workshops.

However, this product is both a “beauty weapon” and a banned drug. Throughout July, botulinum toxins successively set off a storm of self-inspection and rectification of enterprises. The new oxygen APP of the medical beauty platform and the small red book of the content community have repeatedly revealed problems such as “botulinum toxins” in violation of the rules of the platform users. The two immediately rectified and responded.

These botulinum toxins, commonly known as “skinny needles” or “cosmetic needles”, can affect motor nerve conduction and relax facial muscles after facial injection, thereby relieving dynamic wrinkles and making people look younger.

From May 2017 to April 2018, the former National Health and Family Planning Commission, the Central Network Information Office, and the Ministry of Public Security jointly launched a joint fight against illegal medical beauty. In the meantime, the Chinese Customs filed investigations and investigated nearly 10,000 cases of smuggling and illegal crimes such as botulinum toxins, with a case value of more than 88 million yuan.

Due to the Internet, the medical beauty market has become extraordinarily messy and mixed with the violations. Under strict control, the botulinum toxins that are not known are still being publicly traded and injected. Is it a management issue, or is the balance of supply and demand already unbalanced?

The beauty industry is developing fast and is undergoing a process from chaos to smooth.

Frequently “over the line”
“A dozen or so botulinum toxins can be used in one month.” Wu Xiaojun, director of the Daxu Road Clinic of the Ninth Hospital of Shanghai Jiao Tong University School of Medicine, remembers that around 2000, botulinum toxin has become the choice of Chinese beauty lovers. Because the wrinkle effect is “immediately seen”, people use “magic” to describe the effect of botulinum toxin on the face.

A “magic” injection that can be thin-faced and can cause wrinkles to disappear is a neurotoxin produced by Botox. This toxin is released as the bacteria die, affecting motor nerve conduction, which relaxes facial muscles and relieves dynamic wrinkles, making people look younger.

Chen Guangyu, director of the Injection Center of the Department of Plastic Surgery, Chinese Academy of Medical Sciences, especially praised the pronunciation of the word “botulinum toxin”. “It is not a simple cosmetic injection, but a neurotoxin, and its toxicity is comparable to that of ‘chemical weapons.’

Botulinum toxin can be divided into 8 types, of which type A is the most toxic, and it is currently the only commercially available botulinum toxin. In 2006, the former State Food and Drug Administration listed it as a toxic drug. These drugs are highly toxic, and the therapeutic amount is similar to the poisoning dose. Improper use can cause poisoning or death.

Currently, China has only approved the listing of two botulinum toxin products. The first one is the domestic product “Hengli”, which is produced by the Lanzhou Biological Products Research Institute; the other is the imported product “Protective”.

Toxic drugs need to be sold by designated dealers. Hengli only allowed 77 dealers to sell; the well-established Chinese seller was the Sinopharm Holding Distribution Center, which designated 56 secondary dealers. This means that a qualified medical institution or medical beauty agency can only purchase compliant botulinum toxin from the above-mentioned distributors.

However, on July 15th, the new oxygen app of the medical beauty platform broke out. Some platform merchants illegally sold illicit drugs such as botulinum toxins under the online market. They had to “hurry” the suspected drug sales violations. Subsequently, the content community Xiaohongshu Information on the public sharing of illicit drugs such as botulinum toxin was removed.

The line is far more than the two. On August 6th, the reporter of Caijing did not completely find out that in the Baidu Post Bar named “Poisonotoxin”, there were 18 posts on the first two pages concerning the illegal trading or use of botulinum toxin. After nine days, the “botoxin” has disappeared. The page shows, “Sorry, according to relevant laws, regulations and policies, this bar is not open yet.” On August 27th, in the Baidu Post Bar named “Heng Li”, there were still netizens selling botulinum toxin products.

According to regulations, the drugs can only be sold to specific medical institutions or medical beauty institutions. These institutions need to obtain the “medical institution practice license” before they can engage in injection beauty.

Cao Dequan, deputy secretary-general of the China Plastic Surgery Association, told the Caijing reporter that botulinum toxin has been included in the drug, from product approval, sales and circulation to injection, all of which need to be strictly controlled. “This is an insurmountable limit.”

On August 27th, the data from the Center for Drug Evaluation of the State Food and Drug Administration showed that there were three imported botulinum toxin products in trial, including Korean botulinum toxin products “powder poison” and “white poison”, and European products “Li Shu”. Proper.” All three products are botulinum toxin type A, which has been approved for marketing in many countries for medical beauty. At present, all three products have completed the clinical phase III trial and are in the “review and approval stage”.

A review expert close to the drug testing center told the Caijing reporter that China is very cautious about the approval of the listing of toxic drugs. Previous reports on unqualified products may affect the progress of the approval process.

According to South Korean media reports, the production of “powder” Korean botulinum toxin manufacturer Medytox has produced chaos, such as unsterilized botulinum toxin products, and pointed out that some non-compliant products may flow to China. Subsequently, Medytox denied the above allegations and issued a statement saying that the “Powder Poison” listing application in China was carried out in accordance with the procedures and is awaiting the final review.

According to data from the American Society of Aesthetic Plastic Surgery (ASAPS), in 2001, more than 1 million people in the United States had injected botulinum toxin before they were approved for marketing. In 2018, only one year, this figure rose to 1.8 million in the United States.

In 2009, when Prosperity was approved for listing in China, it could be used for “wrinkle beauty”, and Chinese researchers have already started operations. As early as 2003, Chen Guangyu’s hospital was responsible for implementing the clinical phase III trial of the domestically-produced product “Heng Li” to expand the indications. One year later, the trial was completed.

However, until 2012, this “wrinkle-removing” function was written into the “balance” manual – it was approved for “improving the temporary treatment of moderate to severe eyebrow lines in adults”. In the past ten years, “Heng Li” has long been used in medical beauty.

A practitioner in the medical beauty industry told the Caijing reporter that the application of botulinum toxin in the field of medical beauty has been pushing the “instruction” in clinical practice.

Taking the popular “skinny face” effect in recent years as an example, medicine is defined as “temporary improvement to significant significant masseter muscle protrusion (hypertrophy)”. “The function of botulinum toxin for ‘face-lifting has not been approved, and the clinical use has been extensive.” Chen Guangyu said that clinical application is updated before the specification, strictly speaking, “foul”. But at this time, clinical practice has been promoted for five or six years, the participants.

On August 27, 2019, the Caijing reporter inquired about the drug clinical trial registration platform of the Drug Administration Center of the State Food and Drug Administration. It was found that Baoshi has applied to expand this “skinny face” indication, and the clinical phase III trial status shows that “in progress” , no trials have been recruited.”

“beauty” and “beast”
No drug, like botulinum toxin, is controversial, but it does not hesitate to ignore the dangerous side, and wants to stop, and gradually get the legal status of “wrinkle beauty”.

Initially, even experts questioned that botulinum toxin is the most toxic toxin in the world, and that injection of botulinum toxin is “being with the most poisonous toxins.”

The discovery that botulinum toxin can be used for “wrinkle removal” is quite accidental.

In 1986, Joan Carruthers, professor of ophthalmology at the University of British Columbia in Canada, accidentally discovered that the wrinkles on the face of the patient had disappeared when treating ocular diseases with botulinum toxin. After that, she collaborated with her husband, a professor of dermatology, to introduce botulinum toxin type A into the beauty field. The wrinkle effect study began with the eyebrow lines and expanded to crow’s feet and forehead lines.

In 2000, there were only the United States, the United Kingdom, and China in the world. These three countries realized the commercial production of botulinum toxin for the treatment of certain neuromuscular diseases. The function of botulinum toxin in medical beauty has not been approved by any country.

The “boundary” did not last long.

In 2002, the US botulinum toxin product was approved for extended indications and was approved by the US Food and Drug Administration (FDA) for “temporary improvement of moderate to severe eyebrow lines in patients aged 18 to 65.” This is the first time that the botulinum toxin “beauty” qualification has been officially certified.

In the same year, the original American “Science” magazine editor Donald Kennedy published an editorial “Beauty and the Beast”, suggesting that the botulinum toxin type A will bring great harm to people while bringing great harm.

Wang Yinyi, the developer of the Chinese product “Heng Li”, also wrote a special article that botulinum toxin is used for skin beauty, not general beauty behavior (or industry behavior), but medical behavior. The unit and individual must be certified.

However, nothing can stop the beauty, and this trend has swept the United States and the world. According to statistics from the International Society of Aesthetic Plastic Surgery (ISAPS), the number of botulinum toxin injections worldwide has exceeded 5 million in 2017.

Today, the glory side is rarely mentioned again. In the promotion of related beauty products, the effect of botulinum toxin wrinkle-reducing face is constantly amplified, and it is intentionally neglected another identity. Although experts like Chen Guangyu insisted on describing it as “poison” and “poorly poisoned”, these were also neglected by those who asked for beauty.

In 2016, the former State Food and Drug Administration issued a special report warning the risk of botulinum toxin injection: improper use of botulinum toxin type A for injection may cause muscle relaxation and paralysis. In severe cases, it may cause life-threatening such as respiratory failure and heart failure. Symptoms of health.

In April of this year, a 23-year-old Chongqing woman went to a medical and plastic surgery facility to fight botulinum toxin, hoping to lose face and legs. A few days later, he gradually developed symptoms such as fatigue, chest tightness, and dizziness. He was diagnosed as “botulinum toxin type A poisoning” after going to the hospital for examination. He was out of danger after hospitalization.

Facial injection is a medical practice and has strict requirements for medicines, medical devices, medical environments and injection doctors. Counterfeit injections can easily lead to facial collapse and asymmetry. If you enter the blood vessels, it will also cause systemic poisoning, difficulty breathing, and those who are allergic to the drug ingredients, and even directly shock.

In May 2016, Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine successively treated 4 patients with botulinum toxin poisoning, all of whom were poisoned after injection of botulinum toxin in the informal channel. The most serious one was sent to the intensive care unit for rescue due to muscle weakness.

After the injection failed, more and more patients went to the hospital for facial repair.

Yang Wei, deputy director of Peking University People’s Hospital, told the Caijing reporter that many people will go to regular hospitals for help after the injection of problems in informal medical institutions. Later repairs also take a certain amount of time.

In the past decade, data from the China Consumers Association showed that China’s annual complaints about disfigurement due to plastic surgery were about 20,000.

Those who buy online or other informal channels cannot even seek legal asylum. Liang Xiaoyue, a partner of Beijing Zhongwen Law Firm, told the Caijing reporter that most of these transactions were “online trading” through the online platform. In the event of adverse consequences, it is difficult to maintain rights because it is impossible to determine the exact information such as the real name, contact information, and contact address.

Some beauty agencies do not have medical plastics qualifications. According to Liang Xiaoyue, these institutions are unable to provide evidence such as medical record registration documents and medical expenses receipts. It is difficult for consumers to defend their rights through medical damage disputes, and only personal injury compensation can be investigated.

Liang Xiaoyue reminded that consumers should choose a qualified institution for cosmetic surgery and save the injection results before and after surgery. After the injection, the hospital may be required to provide a complete original or copy of the injecting medical record for daily storage.

Cao Dequan told the Caijing reporter that the association is establishing a list of medical institutions that can provide formal products. Taking botulinum toxin as an example, it will cooperate with manufacturers to publish a list of formal medical institutions that can provide “balance” and “guaranteed”.

Beauty or medical
“43 days, the state of the face is different every day. On the whole, the whole face muscle collapses, and the face begins to have a pit that breaks muscles. You can’t laugh naturally. You can only laugh hard. The breathing is improved, but the nose is not ventilated.”2019 At the end of April, a consumer who injected “Powder Poison” shared his experiences on “Little Red Book”.

Xu Jun, former chief physician of plastic surgery at the 301 Hospital of the People’s Liberation Army, did not recognize the botulinum toxin injection as a beauty seeker. In his view, this would make people ignore the medical risks of this behavior, “it should be said that patients are more appropriate.”

Botox is used as a narcotic drug, which is kept by a special person in the hospital and needs to be recycled after use. The delivery of medicines is extremely demanding. “This toxin is a protein that needs to be transported at a low temperature and cold chain. When the temperature is high, it will smell.” Chen Guangyu said.

Injection of botulinum toxin is a delicate activity. A bottle of botulinum toxin is 100 units and needs to be accurate to 0.5 units at a certain point on the face. The process of drug injection varies from person to person. “Everyone needs the point of injection, the amount of each point or each injection is different,” Chen Guangyu told the Caijing reporter.

Institutions that carry out medical beauty services should obtain the “Medical Institution License” and hang in a prominent position. The injecting physician should obtain the “Physician Qualification Certificate” and register with the medical institution, and the medical beauty service project should also be filed with the local health and health administrative department. The relevant person in charge of the National Health and Health Commission has introduced that the above information can be obtained through public information in the organization, and the agency and personnel qualification information can also be inquired through the official website of the health and health administrative department.

Some organizations hire employees who have not obtained any qualifications, and put them into a “consultant” to provide medical advice. Some injecting doctors do not have a fixed workplace, and wherever they go, they go there. Chen Guangyu told the Caijing reporter that the above acts are illegal and illegal. Injection of botulinum toxin is a medical practice and should be consulted and injected by a professional doctor, and the doctor can only perform botulinum toxin injection at the registered medical institution.

The location of the injection is very particular. A doctor in a chain medical beauty institution in Beijing said that it is like playing a forehead pattern. The requirement is that when the eyes are in a double-headed view, the pupil is in the middle of the forehead, and the forehead area formed by the middle of the eyebrow is bounded. Once you pass the area, it will cause the eyebrows to be lowered, the eyelids to droop, and so on.

A number of interviewees told the Caijing reporter that the injection of botulinum toxin is a very precise job. “If you don’t play well, it will become stiff.”

Not every doctor can do medical beauty. Cao Dequan said that in addition to the qualifications of practicing doctors after examination, it is necessary to go through professional study and record, in order to become a medical beauty attending physician.

Seeking beauty is eager, and in various channels, it is still full of illegal drugs. According to previous reports from the Korean media, from the first four months of 2014 to 2019, the amount of “powder poison” exported to China accounted for 50% of the total export of Korean botulinum toxin.

The seven-department of the former National Health and Family Planning Commission, the Central Network Information Office, and the Ministry of Public Security jointly launched a one-year special campaign to rectify illegal medical beauty, which has never been seen before. An industry source close to the National Health and Health Commission said that in the future, the special actions to rectify illegal medical beauty will be normalized everywhere.

Many interviewees described the above-mentioned special actions as “severe strikes”, but they did not have much confidence in reversing the chaos in the beauty and medical industry. In 2002, a report once wrote that “the situation of botulinum toxins out of control in the beauty wrinkle market has not been fundamentally reversed”. In the opinion of many insiders, 17 years later, this sentence still applies.