Plastic/Reconstructive

TEI Biosciences, Inc. has gained FDA Investigational Device Exemption (IDE) approval to initiate a human clinical trial to gain specific … continue reading “Trial Will Test SurgiMend® PRS Breast Cancer Reconstruction Claims”

According to a release from the UK’s MHRA, its Swedish equivalent has adopted the position that PI implants should be removed as a precautionary measure. The MHRA has issued its own statement reasserting its position that this is not necessary in all cases.

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 … continue reading “Last Days Of PIP Trial”

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.