Tuesday, June 5, 2012

SmartPlug complications? REPORT THEM TO THE FDA!


If you have a patient who had canaliculitis or another complication from a SmartPlug, for goodness' sakes report it to the FDA on the MAUDE database.

Here's the link to MAUDE.

And while you're at it, make sure you report it to Medennium too on their Contact page. Device manufacturers are required to notify the FDA of post market complications they become aware of.

I just had a look and there are only 14 reports of SmartPlug complications on MAUDE - on this device that has been on the market almost a decade and which has been studied extensively. (To find them, search first under SmartPlug and separately under Smart Plug.)

14, seriously? How about the 19 in the Hill study, or the 41 in the study group, or the ones in the Chou study, Burgess study, Mazow study? Let alone the ones in all the other hundreds of cities (and not a few countries) where none of these study authors practice? Why isn't anybody reporting these things? How is the FDA supposed to monitor stuff if nobody ever tells them anything?

This is feeling like a rerun of Ladarvision, which left me absolutely heartsick. There were so many people affected and neither doctors nor the manufacturer were reporting the complications until the FDA practically sat on the manufacturer's head by recalling the device till the issues where addressed. Surely we can do better than this.


If you have had a Smartplug complication of any kind, ask your doctor to report it to the FDA via MAUDE and to tell it to the manufacturer. If they are reluctant, do it yourself. Come to think of it, do it yourself anyway - if it's a duplication they'll figure it out and deal with it. See links above.


I just learned that one of my oldest (in refractive surgery years that is) online eye pals was also a victim of this device and is facing surgery. Of all the people for this to happen to, did it have to happen to someone who already got the worst luck of the draw from RK? Really? 

Surely, surely we can stop more harm from happening. There is no need to let an evidently bad device sit on the market year after year while more people get harmed. 

Take action. Smart Plugs need to be withdrawn from the market. 

Abstract: Direct costs of dry eye in Japan

This is going to sound incredibly cheap to DEZ veterans. Just bear in mind it's for a random group of dry eye patients, not just severe cases.

This study was performed to estimate the annual direct cost incurred by dry eye patients, which includes expenses for treatment and drugs, as well as the cost of punctal plugs.
The study group consisted of 118 dry eye patients aged 20 years or older who visited any of the 15 medical care facilities that participated in this prospective cohort dry eye study. We estimated annual direct costs from outpatient medical records and survey questionnaires obtained from patients.
Of the total patients enrolled, 10 were men and 108 women, and their average age was 64.1 ± 11.2 years. The number of hospital visits made by patients was 5.8 ± 3.6 per year. Among those who used ophthalmic solutions, the numbers of bottles used per year were as follows: 32.1 ± 20.8 bottles of hyaluronic acid ophthalmic solution (87 patients), 53.1 ± 42.2 bottles of artificial tears (40 patients), and 33.2 ± 23.2 bottles of over-the-counter eyedrops (15 patients). In patients with punctal plugs, 4.1 ± 3.9 plugs were used annually. The annual drug cost was 32,000 ± 21,675 Japanese yen (323 ± 219 US dollars). The clinical cost was 16,318 ± 9961 Japanese yen (165 ± 101 US dollars). The total direct costs including punctal plug treatment amounted to 52,467 ± 38,052 Japanese yen (530 ± 384 US dollars).
Although treatment modalities for dry eye in Japan were different from those in the US and in European countries, the direct cost of dry eye patients in Japan was comparable with that reported in those countries. Considering the high prevalence of dry eye, the direct cost of this chronic condition may be significant.

Clin Ophthalmol. 2012;6:755-60. Epub 2012 May 16.
Mizuno YYamada MShigeyasu C.
Division for Vision Research, National Institute of Sensory Organs, National Tokyo Medical Center, Tokyo, Japan.

Abstract: High school DES in a county in China

Phew. 23.7% of Shouguang high schoolers have dry eye?!

Purpose: To determine the prevalence and risk factors for dry eye syndrome (DES) among senior high school students in Shouguang, a county of Shandong Province, China.
Methods: A cross-sectional survey was conducted in July 2010, and 1902 senior high school students were selected by multi-stage sampling to answer a questionnaire assessing the prevalence and risk factors for DES. DES was defined as the presence of a previous clinical diagnosis of DES or severe symptoms (both dryness and irritation constantly or often). Risk factors associated with DES were evaluated with a χ(2) test and logistic regression analyses.
Results: The prevalence of DES was 23.7%. In univariate analysis, myopia (P < 0.0001), contact lens wear (P = 0.020), inadequate refractive correction (P < 0.0001), frequent self-administered topical ophthalmic medications (P < 0.0001), and poor sleep quality (P = 0.007) were significantly associated with DES. In multivariate analysis, inadequate refractive correction (P < 0.0001, odds ratio, OR 1.980; 95% confidence interval, CI 1.577-2.488), frequent self-administered topical ophthalmic medications (P < 0.0001, OR 1.838; 95% CI 1.399-2.410), and poor sleep quality (P = 0.001, OR 1.342; 95% CI 1.054-1.709) were significant risk factors for DES.
Conclusions: Senior high school students are a neglected population with a high prevalence of DES. Preventive measures directed against risks factors for DES among senior high school students may help reduce the prevalence and provide a positive impact on students' health.
Ophthalmic Epidemiol. 2012 May 31. [Epub ahead of print]
Department of Ophthalmology, Qilu Hospital, Shandong University , China.