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And the problems with medical devices continue…FDA finds that there has been a 97% increase in Medical Device Recalls in the Past Decade

Posted on: May 12th, 2016 by Lory Sopchak No Comments
And the problems with medical devices continue…FDA finds that there has been a 97% increase in Medical Device Recalls in the Past Decade

I do not like to go to the doctor. I do not have anything against doctors. I respect what they do. Prior to going to law school, I debated going to medical school but soon came to the self-realization that even being in a doctor’s office for more than an hour gives me anxiety. Furthermore, when you have to go and see a medical doctor, you are likely going because you yourself are not feeling well or someone you care about is not feeling well. However, one thing I will say is doctors most times provide resolutions to our medical problems. If you visit a doctor for a sinus infection, you are likely given an antibiotic and within a few days, you are feeling better. If you have heart problems and seek the help of a cardiologist, there is usually some sort of procedure that he/she can perform to help the function of your heart. Sometimes solutions that doctors utilize to treat medical problems involve some sort of medical device and although these devices can be extremely helpful in treating the aliment or problem that the patient seeks, the FDA has found a 97% increase in medical device recalls in the past decade.

In 2014, the FDA’s Center for Devices and Radiological Health (CDRH) published a report regarding the medical device recalls over the past 10 years. The FDA found that between 2003 and 2012, the annual number of medical device recalls had increased 97%. Recalls almost doubled during the 10-year study, increasing from 604 to 1,190, while the total number of products recalled in that time increased from 1,044 to 2,475. Recalls of medical devices are broken into three classes: Class I, Class II and Class III, with Class I being the most severe (which could cause serious harm or death) to Class III being the least severe. The FDA found that Class III recalls actually declined during the 10-year study, while Class I, the most severe class of recalls, rose from seven (7) to 57 in that time. The majority of recalls during this 10-year study were designated as Class II recalls, which means the device may result in temporary or medically reversible adverse health consequences. During the study period, Class II recalls increased from 460 in 2003 to 1,043 in 2012.

This information really scares me. Representing hundreds of women who have experienced severe personal injuries as a result of Transvaginal Mesh, I understand how often medical devices get used by doctors to treat seemingly common problems. Many women, as a result of child birth, experience Pelvic Organ Prolapse and/or Urinary Incontinence. Prior to reports of injuries and medical problems associated with this mesh product, doctors utilized this product because it was targeted to be a safe and effective measure to treat a problem that plagues a lot of women when in fact, it was not safe or effective and has greatly ruined the lives of many thousands of women who had this product implanted. The FDA concluded that the observed increase in medical device recalls is likely due to the fact that product makers have become more vigilant in reporting adverse events; however, research published this year indicates that between 2004 and 2014, manufacturers delayed reporting more than 160,000 adverse drug events to the FDA, which is about 10% of all adverse event reports and includes more than 40,000 deaths.

Most experts believe that the rise in recalls have a lot to do with the lack of pre-market clinical testing and even though I have limited knowledge about this, I have to say that I agree. Transvaginal Mesh was not adequately tested prior to its placement in the medical community; yet, it was advertised and sold to doctors who wanted to provide help to their patients who were experiencing a pretty significant medical problem that is organ prolapse and/or incontinence. These doctors relied on the information that the manufacturers provided them about the product and therefore, recommended its usage to their patient. However, had the product been adequately tested by manufacturers prior to its placement in the medical community, they would have discovered that the product can become embedded inside of woman’s organs causing infection, bleeding, pain during intercourse while not even fixing the prolapse or incontinence issue. However, the manufacturers sold the effectiveness of a product to tens of thousands of doctors with no real evidence that the product would be safe and effective.

This might be a rare occurrence (however, based on the increase in recalls, I do not think it is) but my sentiment is this – manufacturers of these medical devices would rather take a chance with its product versus spending extra money to make sure its product is safe and effective. There is a rush to get the product utilized by the medical community despite the fact there is no real testing being done to prove that the product will be effective and do more good than harm. Perfect example is Transvaginal Mesh but the list goes on and on and on. I am not saying that medical devices do not save lives or act as a solution to a major medical problem; however, I think that this increase in recalls proves a point that these manufacturers are too concerned with profit and not how well the product actually works. This practice is disturbing and a health danger to us all.

If your doctor recommends using a medical device, please do your own research, go to the FDA website or ask questions about the device – how effective it is, whether it has been the subject of any major recalls and whether the use of the medical device is the only option to treat whether medical issue you have.  There has just been too significant of an increase in problems associated with these medical devices to trust that the one recommended for you could not lead to more severe problems in the future.