были произведены под обновленным брендом и продавались под названием M implants. Это предупреждение было разослано по всей Европе 24 июня 2010 года, чтобы прекратить использование продукции Rofil Medical.
Буквально на днях Международный союз пластической реконструктивной и эстетической хирургии получила сообщение из Финляндии о том, что у одной из пациенток был эксплантирован M implant, который был вставлен незадолго до этого. Rofil Medical признана банкротом с 2009 года. Все предупреждения, которые относятся к имплантатам PIP, относятся и к продукции M implants. Поэтому хирургам, которые использовали M implants при маммопластике, следует информировать своих пациентов и осуществить осмотр.
Приводим текст письма президента IPRAS (International Confederation for Plastic, Reconstructive and Aesthetic Surgery), обращенное ко всем специалистам в области пластической хирургии:
Dear colleagues,
the German Federal Institute for Drugs and Medical Devices BfArM just informed me that the breast implants PIP and M implants, marketed by the Dutch company Rofil Medical, are identical. Obviously PIP implants were "rebranded" and sold under the name M implants. There was a warning sent throughout Europe to stop the use of Rofil Medical M implants on June 24th, 2010.
We were informed by a plastic surgeon from Finland yesterday, that he explanted an M implant, that was recently inserted in a country in his neighbourhood.Rofil Medical has filed bankruptcy already in 2009. All the warnings that have been issued for PIP implants apply to M implants as well.
If you have used M implants in the past, please inform your patients and call them in for an examination.
If you happen to have M implants on stock, please contact your supplier and return them.
We expect the French Health Authorities to publish an announcement tomorrow December 23rd in regard to PIP implants. Their recommendations will also apply to all patients with M implants.
We shall inform you immediately.
We also would be very grateful if you could send us all information regarding the use of M implants since June 24, 2010 which might be available to you. Please inform us as well if you have used M implants and if so in how many cases. We need to know urgently how many patients we have to expect in addition to the 300.000 patients who have PIP implants.
The information which we sent to you earlier this month regarding all other breast implants continues to be valid. Please use this information to reassure your patients that they may feel safe with their implants.
Best regards
Marita Eisenmann-Klein
President IPRAS
3616
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