Know the Risks and Benefits of Medical Devices

Medical science continues to make great progress in diagnosingillnesses and treating them. Devices of many types allow doctors to see insidethe body to diagnose a variety of conditions. Other types of medical devicesthat are used or implanted inside the body provide relief from many painfulconditions. However, no matter how far medical science has progressed, thereare still risks and benefits that people need to consider before undergoingeven the most routine procedure involving a medical device.

Here are a few common devices and procedures, as well as someinjuries and issues that have been associated with them.

Medical Scopes

Each year, millions of people in the U.S. have a procedure witha medical scope of some type. In these procedures, a doctor places aninstrument called an endoscope inside the body to examine the esophagus,stomach, bile ducts, colon, lungs, bladder, or other organs. After eachprocedure these devices are cleaned and re-used on another patient. Duodenoscopes,which are used to diagnose and treat stomach and other GI tract conditions,have been of particular concern.

Since 2013, at least 35 people have died from after having aprocedure that used a duodenoscope. The problem is that the design of the scopemakes cleaningit extremely difficult, so even if the scope is cleaned according to themanufacturer’s instructions, bacteria can still be trapped inside the scope andtransferred to another patient. A paperpublished in April 2018 showed that 71 percent of scopes tested at three majorU.S. hospital were contaminated with bacteria.

In 2015 the FDAdirected three duodenoscope manufacturers (Olympus, Fujifilm, and Pentax) tostudy this issue. Interimresults of these studies released in December 2018 showed that up to threepercent of samples were contaminated with “low-concern” organisms, and up to threepercent were contaminated with organisms of high concern. Sampling iscontinuing.

One manufacturer, Olympus, pled guiltyin December 2018 to charges of failing to file reports about infections stemmingfrom its scopes.  The company agreed topay $85 million to resolve the charges. Additionally, the company settled lawsuitswith two women whose husbands died after undergoing a procedure with the scopeand becoming infected with a “superbug” bacteria resistant to most antibiotics.

Other types of scopes are similarly difficult to clean. Bronchoscopes,which are used to look inside the lungs, have also been found to be contaminated,even after cleaning, and have likewise been linked to “superbug” infections.

Bone Cement

There are over a million joint replacements performed eachyear in the U.S. In many of these procedures, the surgeon uses bone cement.Bone cement doesn’t actually “glue” the joint into place; it fills the spacebetween the artificial joint and the bone to keep the joint in place. The useof bone cement in joint replacements is not without complications, however. Thebone cement can break loose, which can cause pain and affect movement. It canalso leakinto the body.

The most serious problem is bone cement implantationsyndrome (BCIS).Fortunately, this complication is rare, but when it happens, it causes thecardiovascular system to collapse and can cause death,often during the procedure.  BCIS hasbeen reported with knee,shoulder, and hipreplacements. One studyfrom the UK reported 41 deaths linked to the use of cement in hip replacement.

BCIS has also been reported in patients undergoing spinalsurgery. As early as 2002, the FDA sent a warningabout a bone cement that was being used to treat spinal fractures and had beenlinked to serious complications, including blood clots in the lungs, cardiacfailure, and death.

In 2011 the government filed charges against a companycalled Synthes, a manufacturer of bone cement. The company had been testing acement that had not been approved by the FDA for use in spinal surgeries. Fivepatients who received the cement had died during surgery after the company ignoredreports that the cement could have fatal consequences. Because the company hadnot been conducting a clinical trial, patients weren’t advised of the risks andgiven a chance to decide if they wanted to receive the bone cement. FourSynthes executives were also charged, pled guilty and sentenced to time injail.

Pelvic Mesh

Pelvic mesh is a relatively recent product that wasinitially marketed in the 1990s to treat stress urinary incontinence in women.After the success of that product, it started being used for pelvic organprolapse. However, the use of the mesh for pelvic organ prolapse has beenassociated with complicationsincluding pain, infection, bleeding, mesh erosion, urinary problems, andperforation of organs, and has prompted tens of thousands of lawsuits.

The FDA received over 10,000 reports of seriousinjuries from pelvic (transvaginal) mesh that occurred from January 2008 toOctober 2018, including 77 deaths. Previously, in 2011, the FDA had issued awarning, and in 2016 they classified it as a high-risk device.

Earlier this year, a woman was awarded $41million in a verdict against one of the manufacturers of pelvic mesh,Johnson & Johnson. Altogether, more than 100,000women are suing manufacturers of pelvic mesh due to the complications they haveexperienced. Some women describe continuous pain due to the plastic of the meshperforating the vaginal wall.

This is another instance of the product being marketed andused without the benefit of long-term study,to the detriment of thousands of women. Transvaginal mesh and is bannedin the UK, Australia and New Zealand. On February 12, 2019, an FDApanel met to discuss the future of transvaginal mesh in the U.S. The paneldecided that rather than pulling the mesh off the market, they would like morelong-term studies.

What to Do If YouNeed a Procedure or Medical Device

If you are faced with needing a medical procedure or device,how can you weigh the risks and benefits? You need to be fully aware of whetherthe device has been studied in clinical trials and has been approved by theFDA. Even if a device has been approved , such as a duodenoscope, you need toknow if there are other issues, such as infection risk, associated with itsuse.

Doing an internet search on the device or procedure may helpanswer questions such as:

  • What is the history of the procedure/device?
  • Has the device been approved by the FDA?
  • What are the risks and benefits?
  • What complications have been reported?
  • Are there ongoing lawsuits associated with thedevice?
  • What are the alternatives?

You should also carefully read the consent document for theprocedure, as it should list the potential risks and complications.

Speak with your healthcare providers also. What is theirexperience with the procedure/device? How many times have they done theprocedure?  What are the most commoncomplications? Before making a decision, you may also want to speak with otherpatients who have had the procedure.

The bottom line is that you should arm yourself with as muchknowledge as you can before undergoing a procedure so you know the risks andbenefits and can make an informed decision.