Smith & Nephew: RENASYS RECALL PR Spin UnSpun
June 23, 2014
Today Smith & Nephew issued a press release:
…announces that it has temporarily ceased commercial distribution of the RENASYS Negative Pressure Wound Therapy product line in the United States.
This action follows instruction from the FDA to obtain new regulatory clearances through the premarket notification (510K) process in respect of certain design enhancements made to RENASYS systems. The applications for clearance have now been filed and are awaiting action.
This action only affects RENASYS products in the United States. OtherNPWT products, including PICO◊, Smith & Nephew’s portable, canister-free system, are not affected.
Smith & Nephew is working cooperatively with the FDA to address its concerns in order to resume distribution of RENASYS products in the United States as soon as possible and regrets any disruption caused to customers.
Sales of RENASYS products in the United States accounted for less than 5% of global Advanced Wound Management revenue in 2013.
Unlike many companies that use language like “they decided” Smith & Nephew did not have that option since the instructions are coming directly from the FDA. (That’s a big red flag). How hard is it for device companies to fill out the 510(k)s properly? Apparently it’s a growing trend. At least the FDA is FINALLY catching on but they still need to catch up!
Language we have seen before: “less than 5%” is meant to downplay the product and is often used to deflect from something bigger. So let’s keep the characteritics in mind as this story unfolds:
Here is a link to an anonymous message board known as Medtechy as it relates to the Renasys recall. These boards can often be salty but there is usually an element of truth and a very distinct pattern. Reps are concerned, management denies, demeans and insults, then threats are made against the concerned reps. Under this model executives and management do not like to be challenged even if what they are doing is unethical or illegal. We don’t know that to be case here, but we’ll have to let it unfold more and follow the PR around Renasys.
And MAUDE reports on this product are missing according to the Medtechy Smith & Nephew thread. Interesting.
Pastor Jim
Holeeeeey Carp! Every time I think I’ve had all the naivete sandpapered off my poor raw soul, something like that Medtechy board will show up and prove me wrong.
I can see now a bit more of why you had to get out of that business…why anyone with an iota of moral fiber would be stung by the attitudes of some of their “colleagues.” Sounds like a bunch of hard-nosed user car jocks out back on the lot doing a doob and discussing how to foist their clunkers off on the rubes!
Melayna Lokosky
There is good and bad in every industry (I have to believe that or I’ll spin off the face of the earth). The goal for me is to bring the good from all sides to the table to create the most positive change (You know? A totally realistic expectation-when you’re dealing with people who put profit above all else). Many of us did (and there are those in the industry that still do) really want to help people through selling amazing technology; but, at the executive level there is so much corruption and that pressure is cranked down on the managers and then reps. It’s tough to see reps as “victims” but as you can tell from the board they are pathologically lied to by their own companies. It’s interesting to get a totally uncensored look behind the curtain. The companies want everyone to think it’s just one or two “disgruntled” employees. I’ve really encouraged Medtechy to try and include some sort of petition page or if enough employee complaints are filed it goes directly to the shareholders –bypassing HR, CEO and the Board. I’m sure there are a lot of legal issues associated with that but reps would LOVE IT!
And on a personal note thank you for being a loyal reader and commenter-I really appreciate it! -Melayna