Adhering to the policy of safe and efficient use of medical devices, Allergan Ukraine LLC, which represents the interests of ALLERGAN, a manufacturer of textured breast implants in Ukraine, informs about the situation regarding the sale of textured breast implants by ALLERGAN.
In the European Union market, the sale of this product has been suspended since December 18, 2018. In Ukraine, textured breast implants, as before, continue to be sold without any suspension.
On estet-portal.com, read what caused such a decision, as well as what the company's further tactics will be.
Suspension of sales of ALLERGAN textured breast implants in the EU
Effective December 18th, ALLERGAN will suspend the sale of textured breast implants and tissue expanders and will also recall all products that remain on European Union markets in accordance with European Union law.
The decision to recall this product in the European Union markets was made in response to a request for a forced recall by the National Agency for the Safety of Medicines and Medical Devices (ANSM), the French regulatory authority. The suspension of sales is due to the expiration of the CE certification of conformity with European standards, and has nothing to do with product quality.
Medical practice: safety in the legal field
Are ALLERGAN textured breast implants available in Ukraine now
While ALLERGAN disagrees with the ANSM request, ALLERGAN continues to cooperate fully with regulators. ALLERGAN defends the benefit/risk profile of its breast implants. The ANSM request and related actions have no basis based on new scientific evidence. In addition, ANSM did not identify any immediate health risks for women with textured breast implants.
The decision to recall products does not affect the availability of textured breast implants in Ukraine.
In Ukraine, breast implants and tissue expanders of ALLERGAN passed the full procedure for assessing the quality management system and verifying the design of medical devices in accordance with the requirements of the Technical Regulations for Medical Devices (Decree No. 753 of October 2, 2013) and received certificates of conformity in November 2016, confirming the quality of products and permission to sell on the territory of Ukraine.
Supervisory audits are also conducted annually by the Ukrainian accredited conformity assessment body to confirm the quality of ALLERGAN breast implants and tissue expanders. This year, the supervisory audit took place in October with a positive conclusion.
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The product recall does not affect ALLERGAN smooth breast implants
ALLERGAN Smooth Breast Implants have recently been re-registered by the GMED Notified Body and are therefore not affected by the above recall. They continue to be sold in the markets of the European Union without restrictions.
The highest priorities for ALLERGAN are patient safety and product quality.
ALLERGAN strives to ensure that products meet all regulatory requirements, scientific evidence and the highest industry standards.
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Safety Profile of Textured Breast Implants
It is important to note that the safety profile of textured breast implants is well known, therefore, given the known risks to patients that may result from implant removal, surgical removal of implants is not recommended based on this information alone.
ALLERGAN takes this situation seriously and will make every effort to provide all stakeholders with timely and detailed updates on this subject as new data become available.
If you have any questions for the company, please send them to: info.ukraine@allergan.com
Texturing Breast Implants by ALLERGAN
Дотримуючись політики щодо безпечного та ефективного використання наших медичних виробів, компанія ТОВ «АЛЛЕРГАН Україна», що представляє інтереси компанії ALLERGAN, виробника текстурованих грудних імплантатів, на території України, звертається до Вас, щоб поінформувати про ситуацію стосовно текстурованих грудних імплантатів
ALLERGAN.
Starting from 12/18/2018, ALLERGAN is suspending sales of textured breast implants and tissue expanders, as well as releasing all products that are no longer eligible for legal status in the European Union markets until the legislation of the European Union.
The decision on the notification on the markets of the European Union has been adopted by the request on the primus stove, which is the best opinion of the National Agency for the Safety of Medicines and Health Care (ANSM), the regulatory authority
of France.
Admission to sale due to the end of the term dії CE certification for compliance with European standards and the same rank is not due to the quality of the products.
Regardless of what ALLERGAN doesn't do well with ANSM, ALLERGAN continues to practice with regulatory authorities around the world.
ALLERGAN is protecting the core/risk profile of its breast implants. Ask ANSM and come in not to miss the occasion, as if they were based on new scientific evidence. In addition, ANSM has not shown any significant risk to women's health with texturized breast implants.
This decision does not affect the availability of textured breast implants in Ukraine. В Україні грудні імплантати та тканинні експандери компанії ALLERGAN пройшли повну процедуру оцінки системи управління якістю та перевірки
проекту медичних виробів у відповідності до вимог Технічного регламенту щодо медичних виробів (постанова № 753 від 2 жовтня 2013 р.) та отримали сертифікати відповідності в листопаді 2016 to the fate, which confirms the quality
of our products and allowed to be sold on the territory of Ukraine.
Surprising audits are also conducted by the Ukrainian accreditation body to confirm the viability of ALLERGAN's breast implants and tissue expanders. In any other way, a visual audit of the letters with positive whiskers.
It also appears that ALLERGAN's smooth implants have recently been re-registered by the GMED Notification Authority and, apparently, the higher-approved label is not eligible. The stench continues to be sold on the markets of the European Union without any annual borders. ALLERGAN's top priorities are patient safety and product quality.
We report all the evidence that our products are exactly in line with current regulatory guidelines, scientific evidence, and the latest Galuzian standards.
It is important to be attached, the profiles of the nonsense of textbooks of the chest izhplataty is good, that is not recommended for the piddle of the ilimi іziki, and the vitaenna is not recommended to
The ALLERGAN Company will be taken seriously as soon as the situation becomes clear and will report our best judgment to all affected parties at the same time and report updated information as soon as possible, after receiving the new informationIf you have winickles, be it a source of company, be a caress, come to us. You can get inquiries at:
info.ukraine@allergan.com
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