All Articles in: 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.
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.
Europe’s Most Popular Breast Implant Gets FDA NodFebruary 21, 2013
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.
No More “Fat Hacking” As FDA Clears HydraSolve™ Lipoplasty SystemDecember 18, 2012
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.
Tummy Tuck TissuGlu® Over First PMA HurdleOctober 31, 2012
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.
Cosmetic Surgeons Must Be “Surgeons”, BAAPS Tells PIPS EnquiryOctober 17, 2012
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?
UK Plastic Surgery Meeting Will Address PIP SituationSeptember 13, 2012
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.
MiMedx Group Announces Changes to Board of DirectorsSeptember 11, 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.
Georgia’s Mimedx Group is a developer of biomaterial solutions for surgical repair of soft tissues using human amniotic membrane. Pretty specialised field and never likely to be sponsoring the Olympics, but nonetheless the company’s recently stated Q2 financials suggest it’s in good shape, having grown consistently and turned red numbers black in the past twelve months.
CE Mark For MEDIHONEY® HCS Coincides With BMJ Paper Supporting Honey Application In Acute WoundsJuly 12, 2012
In one of life’s pleasing little coincidences a newly published meta-review of wound care studies has, among its conclusions, established that topical honey reduces wound healing time when compared to film or gauze-based dressings for burns. Derma Sciences, Inc., with perfect timing has announced the CE Marking for its patented MEDIHONEY® HCS (hydrogel colloidal sheet) dressings, containing (you’ve guessed it), honey.
BAAPS has issued a statement broadly supporting the conclusions of the Chief Medical Officer’s report into the PIP breast implant situation. The association is urging women to take up the offer of consultation and potential explantation, and urging the private sector providers to do exercise their own duty of care.
PIPs Not Toxic, Says ReportJune 18, 2012
Sir Bruce Keogh, Medical Director of the UK’s NHS, has released his report on the PIP scandal, which reassuringly suggests the content of the implants, while being suitable for mattresses, is also non-toxic to humans. His advice to patients remains the same; If they’re troublesome, take them out.
Acellular dermal matrices provide good outcomes, with low complication rates, when used for breast reconstruction after mastectomy for breast cancer, according to a study in the June issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons (ASPS).
Mölnlycke Health Care has announced that it has acquired a pioneering electrical stimulation technology that is said to help accelerate wound healing. The product, currently marketed under the name of woundEL® has been purchased from Gerromed GmbH and is in an early phase of commercialisation.
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