The FDA recently published a news release warning hospitals and doctors’ offices of a shipment of devices used in women’s health care that was stolen before being sterilized.
They were on the way to the place where this is done. And they already had labels indicating they had been processed. This theft also involved other medical devices as well.
The devices were stolen sometime between April 8 and April 11 and are labeled “sterile,” even though they are not. It is likely some of these stolen products could end up in Atlanta. Boston Scientific, the company involved, has an Atlanta office. However, the FDA did not release this information until May 3, 2011; almost a month later. And the public made aware yesterday, July 29, 2011.
“The affected devices include certain lots of products in the “Resolution” line, which are used in gastrointestinal procedures, and certain lots of “Flexiva” and “AccuMax” devices which deliver laser energy. The affected products also include certain lots of products in the “Advantage System” which are used in urology procedures, and one lot of the “Pinnacle Pelvic Repair Kit.” You can see more about this kit at link end of this article including a video.
Since these items are not sold in retail stores by any means, it is up to the women and others to ask their physicians if they have checked to make sure they are not using any of these un-sterilized devices. Health care providers are asked to call Boston Scientific at 866-868-4004 if they discover they have any of the affected devices or have questions.
Boston Scientific Corporation has a small office here in Atlanta of less than twenty employees. However, they have about 25,000 nationwide. So Atlanta physicians, hospitals and patients should be aware. This company makes many different devices with this huge nationwide workforce.
It was reported yesterday, July 29, 2011, that they were laying off employees and sending jobs to foreign countries. Many companies will likely follow suit now that Obamacare is being instituted. They can get cheaper labor and have fewer taxes. And in light of the many recent recalls of various products from China and other counties, we can expect cheaper (and faulty products) coming back into our country. If you have any questions about this you can contact the Atlanta office at (678) 441-8000.
Even though they were stolen prior to being processed, the FDA is warning hospitals and doctors to be on the lookout for them. If they are used, they could present health risk in the form of infection. There should be some kind of purchasing agreement that would prevent them from buying products from an unreliable source.
If they were stolen, who is selling them to the hospitals? They must have felt like they had a market for them.
If this kind of “accident” can happen here in the US what can we expect with cheap slave labor in other countries?
They stated, “It is recommended that health care professionals monitor and treat patients for adverse events, such as operative infection if they suspect or know that the below stolen non-sterile devices have been used.”
They further stated: “Boston Scientific Corporation is working with the U.S. Food and Drug Administration and law enforcement officials to recover this stolen shipment. These devices are used in different type of surgical procedures and could lead to serious infections. This is listed as “Urgent,” and involves endoscopy, urology, and women’s health devices. It would be prudent for patients to consult with their medical providers to make sure none of these devices are used in their procedures.”
Link to “Pinnacle Pelvic Repair Kit.” http://www.bostonscientific.com/Device.bsci?page=HCP_Overview&navRelId=1000.1003&method=DevDetailHCP&id=10118851&pageDisclaimer=Disclaimer.ProductPage
Atlanta Woman to Woman Examiner is interesting in bringing news and information to women of all ages toward better lives and better health. If you would like to be notified when new articles are published, you may subscribe at no charge. If you or someone you know has had a recent medical procedure using one of these devices and has experienced any kind of infection, please let them know so that they can inform their medical team.