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.
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.
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.
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.
3D Systems Corporation has announced that it has acquired San Francisco start-up Bespoke Innovations™, Inc. Bespoke develops proprietary, integrated scan, design and print technology that is designed to deliver custom fit prosthetics, orthotics and orthopedic devices that improve treatment and lifestyle outcomes.
Lord Howe’s report into the PIP breast implant scandal and specifically MHRA’s handling of it, suggests that the agency acted appropriately given the information available and the regulatory constraints existing at the time. A four year delay between first notification and ultimate action on the face of it looks like a long time, but Lord Howe seems satisfied enough.
Smith & Nephew, Inc. acquires Kalypto Medical, Inc., further investing in Negative Pressure Wound Therapy to deliver continual innovation
Andrew technologies claims its solution to lipoplasty avoids the need for traumatic cutting of fat, using as it does its clever liquefaction technology to selectively target fat cells.
When politicians get involved in issues some of us have spent decades involved with, the result is bound to have a few badly thought through components. In the case of the European MEPs they’ve done an acceptable job of identifying the medtech regulatory issues, tinged with a bit of populist reactionary stuff that would serve nobody.