FDA asks Allergan to recall textured breast implants
FDA has finally drawn a line in the sand on an issue that has plagued the breast implant industry for years, writes Amanda Pedersen in sister brand MD+DI. On July 24, the agency called on medical device manufacturer Allergan to take specific models of its textured breast implants off the market due to the risk of a rare type of cancer, she reports.
The request from FDA comes on the heels of an updated worldwide total of 573 unique cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including 33 patient deaths. Most of the BIA-ALCL cases were attributed to Allergan implants.
Back in April, France announced that it would ban textured and polyurethane-coated breast implants and Canada's regulatory agency advised Allergan that it will suspend those types of implants as a “precautionary measure.” At that time, FDA said it would continue to monitor cases of BIA-ALCL but did not suspend or ban sale of the devices.
Breast implants on the market today have a silicone outer shell, with either a textured or non-textured surface, and are filled with silicone gel or saline, explains Pedersen in the MD+DI article. “Over the years there have been reports of risks associated with breast implants, such as capsular contracture, implant rupture and BIA-ALCL. More confirmed cases of BIA-ALCL have been reported in patients with textured surface implants than in patients with smooth-surface implants, the agency said in March.”
Of the worldwide total of of 573 unique cases of BIA-ALCL and 33 patient deaths, 481 of the cases were associated with Allergan textured breast implants.
Medtech and the final frontier
The 50th anniversary of the moon landing on July 20 inspired countless articles and programs across all media. As you might expect, PlasticsToday focused on the contribution of plastics to space travel yesterday and today. MD+DI chose the medical orbit, featuring “out of this world medical devices inspired by space” in a slide show.
Highlighted technologies include the development of portable ventilators; the use of origami principles to design spacecraft, which led to use of the technique to design ultracompact surgical tools; and research into nanotechnology-enabled deep brain stimulation to treat disease.
Medical 3D printing startup closes $3 million funding round
Axial3D announced this week that it had raised an additional $3 million in funding, which it will use to expand headcount at its Belfast headquarters and to support expansion in the U.S. market. The company, which was founded in 2013, is developing an automated 3D printing solution for the healthcare sector.
The funding round was led by London-based Imprimatur Capital Fund Management, an international science and technology investor. The round was also supported by a U.S. investment consortium consisting of a number of surgical angel investors, which was not named in the press release. Axial3D’s previous institutional investors Techstart Ventures, Clarendon Fund Managers and Innovation Ulster Ltd. also participated in the round.
“Following our recent collaborations with Tallahassee Memorial Healthcare and University Hospital Basel, we will focus further on the North American and European markets,” said CEO Daniel Crawford. “This includes opening an office in the USA, and recruiting more talent into our team, particularly to grow our machine learning capability. This will enable us to continue to innovate and find new ways to bring 3D printing on-demand to the entire healthcare sector.”
The most innovative medical devices of the year
The finalists of the 13th Annual Prix Galien USA awards in the pharmaceuticals, biotechnology and medical technology categories were recently revealed. The winners will be announced at an awards ceremony on Oct. 24, 2019.
The Galien Foundation recognizes and rewards scientific innovation that improves human health. Founded in France in 1945 by pharmacist Roland Mehl, the U.S. component was launched in 2007. The awards ceremony and dinner is traditionally held at the New York City Museum of Natural History.
This year’s finalists in the medical device category include a device from Boston Scientific that can predict heart failure weeks in advance, deep brain stimulation technology from Medtronic for epilepsy patients and a hearing aid that also tracks body and brain health from Starkey Livio AI.
A slide show featuring the 17 finalists in the medical device category can be viewed on the Medical Design & Outsourcing website.