Your Medical Device News Resource
Somehow the idea that using an illicit material in a bodily implant is now OK, regardless of whether it’s approved. So claim the defendants in the PIP case which has seen its closing remarks today. This cavalier approach is what got PIP into hot water, but they seem to be in a state of denial that they’ve done much wrong at all.
Categories: News, Plastic/Reconstructive
So we’re nearly there. The trial of PIP boss Monsieur Mas is at the stage of final remarks and prosecutors are calling for a sentence amounting to four years in jail for a variety of offences including aggravated financial fraud. According to an item in today’s (May 16) Daily Telegraph (UK), prosecutors also called for PIP [...]
Categories: News, Plastic/Reconstructive
Parametrics Medical, LLC, a private tissue bank has announced its release of its Coll-e-Strong line of soft tissue allografts. Using E-Beam Technology, to terminally sterilize the tissue without compromising the biomechanical properties of the collagen, the company claims its allograft line is the first to bridge the gap between biomechanics and sterility.
Categories: Knee, Orthopaedics, Plastic/Reconstructive, Shoulder, Sports
It’s a form of ultimate recycling, fat tissue removed using Andrew Technologies’ HydraSolve device now being FDA cleared for reinjection into the same patient.
Categories: Approvals, Plastic/Reconstructive
Two main court cases attracted our interest this week. While the situations contrast, the common thread of patient suffering runs through both cases.
Categories: Hip, medlatest Editorial, Plastic/Reconstructive
Jean-Claude Mas and his allegedly comspiratorial team from PIP start their trial today, facing charges of aggravated fraud in France’s biggest legal proceedings.
Categories: Plastic/Reconstructive
Tenex Health’s TX1 is a clever ultrasonic device can cut and debride damaged tendon without affecting the surrounding healthy tissue. Now FDA has expanded its indications with a new 510(k) clearance that enables the company to press on with its pipeline of applications.
Categories: Approvals, General Surgery, Orthopaedics, Plastic/Reconstructive
Manufactured by Allergan™, “Gummy Bear” breast implants have been used successfully in Europe and Canada for more than a decade. Now they have been cleared for market in the United States.
Categories: Approvals, Plastic/Reconstructive
Allergan’s Natrelle® breast implant line now extends to a newly FDA approved shaped silicone gel option. The implant is already available in Europe and has proven popular, not least because of its anatomical shape.
Categories: Approvals, Clinical Studies/Trials, Plastic/Reconstructive
A new liposuction cannula that avoids the traumatic sawing action employed during fact removal seems like a good idea. Now it’s gained FDA clearance.
Categories: Approvals, Plastic/Reconstructive, Techniques
Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, has announced that it has received approval from the U.S. FDA for the first of four modules of the Company’s PMA filing plan for its TissuGlu®Surgical Adhesive product.
Categories: Approvals, Plastic/Reconstructive
AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, has received European CE Mark approval for AeroForm™, a needle-free, patient-controlled tissue expansion system.
Categories: Approvals, Plastic/Reconstructive
It’s taken the illegal actions of a rogue implant manufacturer to catalyse what looks increasingly like a radical reform of the cosmetic “surgery” industry in the UK. Lots of sensible recommendations from the aesthetic surgical fraternity, but weren’t these obvious deficiencies?
Categories: medlatest Editorial, Plastic/Reconstructive, Regulatory News
The UK’s Aesthetic Plastic surgeons meet next week in an annual event that might just attract more attention than usual in the wake of the PIP scandal which has cast something of a cloud over the specialty throughout 2012.
Categories: Congresses and Meetings, Plastic/Reconstructive
Human amniotic membrane-derived device company MiMedx Group, Inc., has announced that its Board of Directors has appointed two new members, effective September 5, 2012. The new directors are healthcare executive Charles R. Evans and Neil S. Yeston, M.D., F.A.C.S., a healthcare practitioner, innovator and leader.
Categories: People, Plastic/Reconstructive
While the toxicology work continues, it seems implant data is still saying the same thing, that PIP implants rupture more frequently than other implants, that in most cases there is no reaction, and when there is a reaction it’s obvious. Most significantly data confirms no resultant cancer.
Categories: Academic Studies, Alerts/Adverse Events, Plastic/Reconstructive
With so much going on in the world of medical technology, medlatest likes to reflect each week on the big news items of the past seven days.
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