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.
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 [...]
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.
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.
Two main court cases attracted our interest this week. While the situations contrast, the common thread of patient suffering runs through both cases.
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.
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.
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.
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.
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.
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.
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.
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?
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.
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.
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.