BfArM

April 7, 2019

Bundesinstitut für Arzneimittel und Medizinprodukte

German state authority for pharmaceutical products and medical devices

Latest News

Concerns about shortages of orthopaedic implants due to the EU Medical Device Regulation

February 16, 2024The German Society for Endoprosthetics (AE) is concerned about potential shortages of artificial hip and knee joints. Bureaucratic hurdles urgently need to be removed, as otherwise the EU Medical Device Regulation (MDR) would increasingly jeopardize patient safety, it said today. The MDR, which came into force in 2021, has been criticized since its inception and the warnings issued at the time seem to be increasingly coming true: Specialized medical devices in particular, which are manufactured in small quantities, are increasingly disappearing from the supply chain. In addition to reducing bureaucratic hurdles, the association is therefore also calling for a simplified approval and recertification process in order to safeguard care and continue to enable innovation. Only this would make it possible to bring implants for special requirements onto the market quickly and unbureaucratically and ensure modern and patient-oriented medical care. Author(s) Source lau/aerzteblatt.de aerzteblatt.de 16.02.2024 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...

Testing company to pay more than ten million euros in breast implant scandal

January 12, 2024In the scandal surrounding defective breast implants from French manufacturer Poly Implant Prothèse (PIP), a court has ordered TÜV Rheinland to pay more than ten million euros. The testing company must compensate 605 of 1,319 plaintiffs. Most of the women in these proceedings come from Great Britain. The court stated that from 2002 onwards, there had been a discrepancy at PIP between the quantity of gel ordered for the breast implants and the number of prostheses produced. This should have been noticed. The TÜV’s lawyer criticized the ruling and recommended an appeal. From 2001 to 2010, PIP sold around one million of the poor-quality implants worldwide. 400,000 women suffered damage to their health. In Germany, Belgium, Italy and Spain, complaints have been dismissed, emphasized TÜV Rheinland. Only in France are there still legal disputes. According to its own information, TÜV Rheinland did not test the implants of the manufacturing company PIP, but certified the company’s quality management system. In 2016, PIP founder Jean-Claude Mas was sentenced to four years in prison and a fine of 75,000 euros for serious fraud and deceiving TÜV. He died in 2019. Author(s) Source afp/aerzteblatt aerzteblatt 12.01.2024 (german original) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...

Implant reduces intraocular pressure

December 29, 2023The US Food and Drug Administration (FDA) has approved an intraocular implant for the treatment of open-angle glaucoma or ocular hypertension. The capsule placed in the angle of the chamber continuously releases the prostaglandin analog travoprost, which improves the outflow of aqueous humor. The implantation of “iDose” frees patients from the daily use of eye drops. It is implanted in the iridocorneal angle between the cornea and the iris. There it penetrates the sclera with its tip, where it is firmly anchored with a barb. The most common ocular side effects, which occurred in 2 % to 6 % of iDose TR patients, were increases in intraocular pressure, iritis, dry eyes and visual field defects, which were mostly mild and improved on their own. Author(s) Source FDA, Reference ID: 5292678 NDA 218010 Page 4 – accessdata.fda.gov This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...

A Double-Lung Transplant and a Pair of Breast Implants to Save a Life

December 21, 2023The patient, had a history of vaping and multiple infections, first viral infections and then Pseudomonas pneumonia. He had a really severe infection in both lungs. He was ventilated but the ventilator was not sufficient to keep him alive. He was then placed on the extracorporeal membrane oxygenation (ECMO), and he was dying on the ECMO, with no other options for him at that time. He was failing antibiotic treatments, and unfortunately, ECMO was not bridged for his survival or improvement. The hope, of course, is that bypassing the heart-lung system allows the lungs times time to heal and eventually you can wean the patient off ECMO, back to the ventilator, and then off the ventilator. But this was not the case here. In his current condition, he was not a candidate for a lung transplant. We came to idea to actually remove the lungs from the patient. The patient would be living without his lungs while we waited for new lungs to be available from a donor. We had to create artificial channels in the heart, reconnecting the right and left side of the body and implanting oxygenators to take over the function of the lungs. The heart was beating in a chest cavity in the absence of lungs stabilizing it from either side. To keep the heart stable two breast implants were put on either side of it. When the transplant lungs arrived, the breast implants were removed and the lungs were put in. Now the patient is out of the hospital, out of rehab, and here, at his temporary home in Chicago and doing really well. Author(s) Source Wilson FP Medscape Dec 21, 2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/a let us know [...] Read more...

New Companies

CircumFix™ Solutions, Inc.

March 19, 2024unregistered register now update records IMPLANTS U.S.A. product group skeletal implant products Varitrax Sternal CircumFixator™ System (for sternal closure) contact n/a This is a post of a nonregistered company. Information given here is checked thoroughly by “Implant-Register”. However we can not guarantee for any material, property or completeness. Products may not be available in all countries. Ask the company for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they may be taken from the companies website. The publishing company may inform us to improve or hide them. [...] Read more...

Glaukos Corp.

February 19, 2024unregistered register now update records IMPLANTS U.S.A. product group eye implants products iDose® TR travoprost intracameral implant iStent infinite® to reduce the intraocular pressure (IOP) iStent inject® W reduction of IOP in adult patients with mild to moderate primary open-angle glaucoma contact n/a This is a post of a nonregistered company. Information given here is checked thoroughly by “Implant-Register”. However we can not guarantee for any material, property or completeness. Products may not be available in all countries. Ask the company for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they may be taken from the companies website. The publishing company may inform us to improve or hide them. [...] Read more...

Suzhou Kangli Orthopaedics Ienstrument CO.Ltd

January 23, 2024unregistered register now update records IMPLANTS CHINA product group skeletal system implants (general) products anatomical plate system bone screws cannulated bone screws interlocking nail system locking plate system straight plate system product group upper extremity implants products metacarpal plate phalange plate product group spine implants products AF RF Spinal System Anterior Cervical Plate I System Anterior Cervical Plate II System Anterior Thoracolumbar Plate System Fusion Device System KCO 3.2 Nail Rod System KLP Posterior Cervical Fixing System KSS-I 6.0 Spinal System KSS-II 5.5 Spinal System (posterior fixation) KSS-II 5.5 Spinal System (anterior fixation) KSS-III 6.0 Spinal System (Slipping) PCS Posterior Cervical Fixing System Titanium Mesh Cage System contact n/a This is a post of a nonregistered company. Information given here is checked thoroughly by “Implant-Register”. However we can not guarantee for any material, property or completeness. Products may not be available in all countries. Ask the company for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they may be taken from the companies website. The publishing company may inform us to improve or hide them. [...] Read more...

New Implants

NEXPLANON®

September 28, 2023IMPLANT PROFILE unregistered register here update records radioopaque the implant X-ray 01 indication hormone-releasing birth control implant for use by women to prevent pregnancy for up to 3 years 02 specific implant, for subdermal use only 03 contraindication(s) ◊◊◊◊◊ 04 implant description ◊◊◊◊◊ 05 specific attributes ◊◊◊◊◊ 06 material etonogestrel 07 implant surface n/a n/a 08 key literature ◊◊◊◊◊ 09 notes about the company n/a 10 approvals CE-Marking (?) FDA-Approval learn more about approvals, certifications, authorities No comments yet. You are welcome to send comments or experiences. HERE, if you received this implant. and HERE, if you placed this implant. Received this implant? You can register it HERE (fee). Placed this implant? You can register it HERE for your patient (fee). current as of 2023-09-25 unregistered / this page is not approved by the provider / unregistered implants have no professionnal lines or advertising This “Implant Profile” shows a non-registered implant. This is a most comprehensive description of the important parameters of an implant. Information given here are checked thoroughly by “Implant-Register” and is not approved by the manufacturer/the company. Illustrations refer to the company, if not shown differently. However we can not guarantee for any material or properties. Implants may not be available in all countries. If there are pictures like logos or implants, they are taken from the companies website. The publishing company may inform us to hide them. [...] Read more...

REFLECT™ Scoliosis Correction System

September 27, 2023IMPLANT PROFILE unregistered register here update records the implant in situ 01 indication minimally invasive implant system designed to correct progressive scoliosis in young patients 02 specific it preservs motion, maintains stability, and allows for future modulated growth 03 contraindication(s) ◊◊◊◊◊ 04 implant description ◊◊◊◊◊ 05 specific attributes ◊◊◊◊◊ 06 material titanium, coated with HA 07 implant surface n/a <picture> 08 key literature ◊◊◊◊◊ 09 notes about the company n/a 10 approvals CE-Marking FDA-Approval learn more about approvals, certifications, authorities No comments yet. You are welcome to send comments or experiences. HERE, if you received this implant. and HERE, if you placed this implant. Received this implant? You can register it HERE (fee). Placed this implant? You can register it HERE for your patient (fee). current as of 2022-08-25 unregistered / this page is not approved by the provider / unregistered implants have no professionnal lines or advertising This “Implant Profile” shows a non-registered implant. This is a most comprehensive description of the important parameters of an implant. Information given here are checked thoroughly by “Implant-Register” and is not approved by the manufacturer/the company. Illustrations refer to the company, if not shown differently. However we can not guarantee for any material or properties. Implants may not be available in all countries. If there are pictures like logos or implants, they are taken from the companies website. The publishing company may inform us to hide them. [...] Read more...

Sientra saline sizer

May 13, 2023saline sizers (discontinued) products round moderate plus projection smooth surface high projection smooth surface teardrop shape, classic base moderate plus projection smooth surface teardrop shape, round base high projection smooth surface [...] Read more...

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