Medical devices are meant to enrich our lives by treating conditions that would otherwise make it difficult for us to live comfortably and do the things we enjoy. In recent years, however, many of the devices that are meant to improve lives are harming patients due to manufactural defects and poor design. The companies that produce these products are often more concerned with getting their devices to market than performing the proper trials needed to ensure that they are safe for use by the patients who rely on them. The following statistics paint an alarming picture concerning the medical device industry and illustrate why it is important to hold companies liable when they fail to place the wellbeing of their patients first.
Defective Medical Device Statistics
- In 2008, there were only 18 high risk medical devices recalled by the FDA.
- This number climbed to 31 the following year and has continued to grow in every subsequent year to date.
- In 2013, 63 high risk devices were recalled by the FDA— which represents an alarming increase of 350% compared to only five years prior.
- As of August 30, 2014, 42 medical devices have been recalled since the beginning of the year.
- In the period of 2008-2011, 45% of the devices recalled were pulled from the market due to a manufactural defect.
- 29% of the recalled devices malfunctioned during use or failed to provide intended results.
- 11% of the medical devices recalled during this period were found to be contaminated in some way.
- The 510(k) program is an approval system that allows the manufacturers of medical devices to bring products to market without first performing clinical trials to ensure product safety and reliability. Manufacturers must only proof that the device is similar to existing devices on the market in order to gain approval through this system.
- 71% of high risk devices that have gained approval through the 510(k) program were later recalled.
- Revisions have been made to this approval process in 2013 in hopes that stricter standards will reduce the number of harmful products allowed to make it to market.
Knee and Hip Replacements: Taking Center Stage When it Comes to Widespread Recalls
- The majority of faulty knee and hip replacement products released on the market gained approval through the 510(k) program.
- Metal on metal devices have been proven to have a significantly higher failure rate and cause more severe injuries to patients who have been implanted with them.
- DePuy Orthopaedics— owned by Johnson & Johnson— was forced to recall its Articular Surface Replacement (ASR) XL Acetabular system in 2010 after it was found that approximately 13% of patients who received the device required revision surgery within the next five years. The device utilized metal on metal components.
- Similar devices made of ceramic components last 15 years on average before any complications or problems with the devices arise.
- By March of 2013, DePuy was facing over 14,000 lawsuits due to conditions and injuries caused by the Articular Surface Replacement (ASR) XL Acetabular system.
- DePuy was also forced to recall its LCS Duofix Femoral Component in Australia. The device is a knee prosthetic that was also comprised of metal on metal components and patients reported many of the same complications with the device that patients receiving the Articular Surface Replacement (ASR) XL Acetabular system reported.
- Zimmer Holdings Inc. was also the subject of several high profile recalls of hip and knee implants.
- The Durom Cup— an all metal hip implant— was recalled after it was reported that the device had failed prematurely in 6% of the patients who were implanted with the device. Initially, Zimmer blamed the failures on the “incompetence of the surgeon” implanting the devices.
- By July of 2008, Zimmer recalled the Durom Cup, claiming that the instructions it provided to surgeons implanting the devices were subpar.
- Zimmer’s NexGen CR-Flex knee replacement experienced similar failures and was pulled from the market when 9% of patients implanted with the device reported pain and other severe complications.
- In April of 2012, Stryker corporation released a statement issuing a recall of its Rejuvenate and ABG II modular-neck hip stem systems, citing safety concerns and recommending that patients contact their surgeons for regular monitoring of potential complications. In many cases, the devices will need to be removed in order to prevent serious or life threatening complications.
- All metal on metal devices present the risk of metalosis— which occurs when toxic metals enter the blood stream. Patients who have received any of these defective products must undergo routine blood monitoring to prevent complications that can arise from metal ions that have entered the body due to the grinding of metal parts against one another.
- In addition to metalosis, patients have reported tissue death, bone decay, intense pain and swelling and tumors at or near the site of the implanted devices.
Transvaginal Mesh Devices
- During the period from 2005 to 2010, there were over 4,000 reports of complications arising from the use of transvaginal mesh devices.
- By 2008, the FDA released a statement warning of potential complications, but asserted that these complications were rare.
- In 2011, the FDA reversed its prior assessment and warned that these complications were not as rare as previously thought.
- 75,000 transvaginal mesh surgeries were performed in 2010 and 10% of those implanted with the devices reported complications.
- In the statement made by the FDA in 2011, it was suggested that transvaginal mesh devices were not as effective an option as traditional procedures used to treat pelvic organ prolapse and stress urinary incontinence. In addition to being less effective, they carried a far greater risk of injury.
- 33 mesh manufacturers have been ordered to safety reviews of their transvaginal mesh products to date.
Birth Control Devices
- The FDA approved Bayer’s Mirena IUD product in 2000. Since its release on the market, there have been over 45,000 reports of severe complications.
- Mirena was marketed with many erroneous claims that have since been proven false. In December of 2009, the FDA openly confronted Bayer about these claims.
- Bayer continues to market the Mirena IUD despite numerous lawsuits being filed by women who have suffered harm because of the device.
- The NuvaRing is a birth control device that was released in 2001 as an alternative to the Mirena IUD. The device is inserted once a month into the vagina to prevent pregnancy.
- The NuvaRing reached global sales of over $623 million in 2011, but many of the women using the device have not been properly informed of the risks it poses.
- In 2008, a petition with 100,000 signatures was presented to the FDA demanding that the NuvaRing be pulled from the market and banned permanently. The petition cited the risk of life threatening blood clots that resulted from the device’s use as the reason and the failure of Organon and Merck to disclose these risks to the public.
- The FDA released a report in 2011 regarding the dangers of the NuvaRing after it performed a thorough study on over 800,000 participants.
- Those who use the NuvaRing are susceptible to an elevated risk of blood clots, which can then travel to the lungs, heart or brain, causing life threatening complications that include heart attack and stroke.
- To date, more than 1,000 lawsuits have been filed by women who have suffered complications from the use of the NuvaRing.
INFUSE Bone Grafts
- INFUSE bone grafts are used about 100,000 times per year in the treatment of arthritis and degenerative bone diseases.
- Medtronic, the manufacturer of INFUSE, has been accused of misleading the public and bribing researchers with money, vacations and other benefits in an effort to encourage them not to report adverse side effects in their findings.
- A settlement of $40 million was paid in 2006 regarding these claims and the same issue was under investigation once more in 2011.
- In 2008, the FDA released a report stating that the improper use of INFUSE bone grafts could cause life threatening reactions that include swelling of the neck and throat and difficulty breathing.
- Hundreds of reports have been filed with the FDA concerning the INFUSE bone grafts and lawsuits are currently being filed on behalf of victims who claim that Medtronic has intentionally withheld information regarding the side effects and potential complications that can arise from the use of its products.
The irresponsible marketing of defective medical devices needs to stop and companies that find ways to cheat the system must be held accountable. If you or a loved one has been harmed because of a defective medical device, contact the medical device recall attorneys at Rosenfeld Injury Lawyers LLC today to schedule a free consultation with an experienced attorney who is happy to answer your questions and inform you of your rights. We will gather the specific details of your case and let you know whether you have a claim, what to expect from the legal process and how to take the first steps. We are confident in our ability to help you and represent your interests— and will never demand payment until we are able to recover compensation on your behalf.