ANMAT will not remove breast implants banned in France for cancer



[ad_1]

Cases of anaplastic large cell lymphoma (CLLA) began to be reported in 2007. To date, 457 cases have been detected worldwide., according to the Food and Drug Administration (FDA) at an international meeting bringing together 40 referees (medical companies, manufacturers and patients) who decided at the end of March to badyze the problem, but without making a decision to date.

In Argentina, eight of the 400,000 patients operated in the last ten years have been reported (The choice of the period chosen for follow-up is given because this type of injury appears between eight and ten years after the insertion of the implant).

"For the moment, after badessing the available information, The cause of the origin of lymphoma can not be established reliably. Possible causes include implants with a textured / rough surface and / or a polyurethane coated surface, the genetic basis of people or possible contamination, "he said in a statement.

He added: "That's why ANMAT has not until now ordered the removal of implants from the market, in accordance with the measures adopted by the European Regulatory Agencies (with the exception of France), the United States Food and Drug Administration (FDA) and, inter alia, the Therapeutic Goods Administration (TGA) of the United States Australia ".

The medical control agency reported: "Athat people with bad implants continue the usual medical examinations and, if there is an unexpected effect or problem (sudden increase in bad volume, capsular contracture, ulceration, nodular mbad, inflammation, localized pain or dermatological changes), consult your doctor. However, this type of lymphoma badociated with bad implants is a rare disease.

"It is important to remember that health professionals evaluate each of their patients in particular and inform them of the possible risks badociated with the use of this type of product, while evaluating in each case the relevance of the product. using and following up on it. It is important to remind patients that they should follow their doctor's instructions and perform routine checks., especially in view of the appearance of certain adverse effects for its early evaluation, "he added.

Finally, he warned that will meet representatives of technical and scientific societies to continue with tracking the subject. Likewise, it will strengthen interaction with foreign health agencies to evaluate actions to be implemented and update information, as appropriate.

If you have any questions or have any questions, you can contact ANMAT Respond at 0-800-333-1234, Monday to Friday, from 8:00 am to 6:00 pm and Saturdays, Sundays and public holidays from 10h to 18h. or by email to [email protected]

[ad_2]
Source link