Medical devices can save and improve lives. Unfortunately not all of them are tested properly before hitting the market, and some have caused injuries. Many injured patients file lawsuits against device makers alleging the products are faulty and companies did not warn them of the complications.
Medical devices are designed to save and improve lives of people around the world. Each day, new advances in technology broaden the horizons of what is medically possible. While cutting-edge products continue to revolutionize the field of medicine, not all devices are as safe and effective as others. Some patients end up with a laundry list of debilitating injuries that change their lives forever.
Devices such as hip and knee implants, transvaginal mesh, Essure birth control and power morcellators can cause complications from disabling pain to spreading deadly uterine cancer. Patients simply seeking a better life are often unaware of the risks of these procedures — risks that can far outweigh any of the device’s potential benefits.
In order to maximize profits, manufacturers of these devices may skip crucial testing to rush products to market, but the companies have a responsibility to ensure that their products are safe. People affected by faulty devices may suffer life-altering complications. Some are unable to return to work, some lose their homes because of financial hardship and some even live the rest of their lives with debilitating pain.
These people turn to the legal system for compensation and file lawsuits against device makers like Johnson & Johnson, DePuy Orthopaedics, Zimmer and C.R. Bard. According to lawsuits, the companies manufactured defective products and hid the risk of complications.
Defective Knee and Hip Replacements
The FDA approves the majority of new knee and hip implants through the 510(k) program, and clinical evidence continues to reveal the grave implications of the program’s flaws. Devices cleared through this process need only be “substantially equivalent” to a device already on the market. This means patients often end up with inadequately tested devices implanted into their bodies.
One class of device, the metal-on-metal hip replacement, exhibits particularly high rates of failure. Also, a growing number of patients fitted with artificial knees face similar complications when their devices fail to properly bond with the thigh bone.
Poorly designed knee and hip replacements may fail and cause bone fractures and dislocation if the joint slips out of alignment. These issues can cause symptoms ranging from pain and swelling to an inability to walk. To fix these complications, patients often require one or more corrective procedures, known as revision surgeries.
DePuy Orthopaedics Devices
DePuy Orthopaedics is a multinational company owned by Johnson & Johnson. In 2010, safety issues prompted DePuy to recall one of its hip replacement devices, the Articular Surface Replacement (ASR) XL Acetabular system.
In metal-on-metal hip replacements like the ASR system, a metal ball connected to the leg’s femur bone rotates within a metal socket attached to the hip. Friction from everyday use causes wear to the components, allowing the release of small metal particles into the body over time.
While each patient reacts uniquely to the metallic debris, the issue has been known to damage nearby tissue and bone — a complication called metallosis. This can cause pain, swelling and loosening of the joint. In some cases, metal ions seep into the bloodstream and create a number of complications in the heart, thyroid gland and nervous system.
In 2013, documents surfaced during the trial of Loren Kransky that revealed J&J knew as many as 40 percent of DePuy ASR hip implants would fail within five years. Kransky sued J&J and DePuy after his ASR hip implant failed and caused debilitating injuries.
The company also defended itself against hundreds of lawsuits over issues with another metal-on-metal hip device, the Pinnacle. At one time, the company faced nearly 14,000 lawsuits.
Zimmer Holdings Inc. Devices
Various knee and hip replacements produced by Zimmer Holdings Inc., another international giant in medical device manufacturing, also have equally concerning failure rates.
In July 2008, Zimmer ceased marketing and distribution for one of its all-metal hip implants, the Durom Cup. Zimmer designed this product for young and healthy patients who require durable and long-lasting implants, but far too many of the devices failed within a few years. Zimmer recalled the Durom Cup, stating that the technical instructions given to surgeons were inadequate.
Zimmer also manufactured artificial knees that were rife with complications. One product, called the NexGen CR-Flex, exhibited high rates of premature failure because it often did not bond with the femur as intended.
One orthopedic surgeon observed NexGen knee failure in 9 percent of 100 patients studied, which caused pain, looseness and often required revision surgery to have the device replaced.
Stryker Corp. Devices
In April 2012, Stryker Corporation issued an “Urgent Safety Alert” regarding two of its hip replacement models — the Rejuvenate and ABG II modular-neck hip stem systems. Stryker developed these systems to offer surgeons an unprecedented range of options as they custom-fit implants for each patient, but post-market surveillance revealed an excessive risk for serious complications after surgery.
While these systems were intended to vastly improve the implant’s stability and range of motion, some patients experienced chronic pain, swelling and damage to nearby tissues. Patients with a high sensitivity to the metal ions may need revision surgery to correct tissue reactions like metal toxicity, bone dissolution, necrosis (premature cell death) and the formation of pseudotumors — non-cancerous growths that cause discomfort.
To prevent future issues with the devices, Stryker recalled the Rejuvenate and ABG II hip systems on July 6, 2012. Following the recall, Stryker immediately ceased global production and distribution of the faulty devices.
Power morcellators are drill-like devices doctors use to remove uterine fibroids and perform hysterectomies. The FDA approved the first morcellator in the 90s and several new devices hit the market since.
Morcellators work by chopping up large chunks of tissue and removing them through a small abdominal incision. These devices allow surgeons to perform complex surgeries and reduce patient recovery time.
While these devices reduce recovery time, they are also linked to a serious side effect, the spread of uterine cancer. Because the morcellator chops up pieces of tissue it can grind up hidden cancerous cells and spread them in the abdominal cavity.
In November 2014, the FDA warned that the “majority of women” should not undergo surgery with these devices. It also required a black box warning for the risk of spreading cancer.
Key manufacturers of these devices include Johnson & Johnson, Karl Storz and LiNA Medical. Many of these companies are now facing lawsuits filed by the families of women who died from uterine cancer they say was worsened by the device.
IVC filters are small, metal cage-like devices designed to trap clots before they travel to the lungs. These types of clots are called pulmonary embolisms and cause about 300,000 deaths each year.
Doctors prescribe these devices for people who cannot use blood thinners — the more common method of preventing clots. The FDA first approved these filters in 1979.
There are two kinds of filters, permanent and retrievable. Retrievable IVC filters are meant to provide temporary protection from blood clots for one to two months before they are removed, but they may also cause serious complications.
In 2010, the FDA announced it received reports of nearly 1,000 adverse events linked to the filters, including device migration, organ perforation and device breakage. In 2014, the agency released another communication stating that doctors should remove devices within two months of implantation. Filters manufactured by C.R. Bard and Cook Medical drew lawsuits from patients who claim the filters broke apart and caused organ damage.
Essure Birth Control
The Essure Permanent Birth Control System is a device marketed by Bayer as the only non-invasive, non-hormonal permanent method of birth control for women. Nearly 750,000 women all over the world used the device to help prevent pregnancy and according to its manufacturer, it is 99.83 percent effective. During the procedure, doctors insert a metal coil into each fallopian tube. Over time, scar tissue builds up to block each tube and prevent fertilization of the egg.
But thousands of women say the device ruined their lives and caused them serious complications such as organ perforation, autoimmune diseases and unbearable pain.
In 2015, the FDA said it received more than 5,000 adverse events reports related to Essure, including the death of four women and five unborn babies. In September of 2015, the agency held a public meeting to determine the safety and effectiveness of Essure. It did not ban the device, but recommended more physician education among other guidelines.
Women who say the device injured them filed lawsuits and started petitions to ban the device.
From 2005 to 2010, the FDA fielded nearly 4,000 reports of adverse effects related to transvaginal mesh, which is used to treat women suffering from pelvic organ prolapse (POP) or stress urinary incontinence. Mesh is made of synthetic plastic and resembles a net with fine holes. To treat POP, surgeons insert the mesh through the vagina (transvaginally) to support the uterus, bladder and bowels and prevent them from descending into the vagina. In stress urinary incontinence, the mesh supports the urethra to prevent involuntary urine leakage.
The FDA issued a Public Health Notification regarding serious complications with transvaginal mesh in 2008, but asserted that adverse events were rare. But by 2011, the FDA reversed its decision. Complications, in fact, were not rare among transvaginal prolapse repairs, as they were found to occur in 10 percent of the 75,000 surgeries performed in 2010. Women suffered organ perforation, severe pain performing daily activities and during intercourse, recurrent infections and other complications.
The FDA ordered 33 mesh manufacturers — including Johnson & Johnson, Bard Medical, American Medical Solutions and Boston Scientific — to conduct safety reviews of their products. As of October 2015, these manufacturers collectively face over 73,000 lawsuits filed by women who say these manufacturers injured them and hid the risk of complications.
Mirena Intrauterine Device (IUD)
Women searching for long-term birth control will find that the Mirena intrauterine device (IUD) is convenient and effective, but the possible side effects, like organ perforation and device expulsion, make the device risky. Mirena is a T-shaped device that is implanted into the uterus to prevent pregnancy for up to five years. The FDA approved it in 2000 and has received more than 45,000 reports of adverse events.
In December 2009, the FDA wrote Bayer, Mirena’s manufacturer, alerting the company that it was advertising false or misleading information about Mirena. The company claimed that women would “feel great,” even though reports show women experienced back pain, breast pain, acne and weight gain. The FDA also communicated to Bayer that it did not fully inform Mirena users of the extent of possible complications.
Despite these dangers, Mirena is still on the market. Women injured by the IUD filed lawsuits against Bayer.
NuvaRing Birth Control
NuvaRing is a flexible ring that is inserted into the vagina once a month to prevent pregnancy. It was introduced in 2001. Since then, 5.5 million prescriptions have been written. The popular device reached international sales of $623 million in 2011. NuvaRing provides effective birth control, but it poses a serious risk of life-threatening blood clots. The blood clots can lead to heart attack, stroke and death.
In 2008, the FDA made safety label changes to NuvaRing after Public Citizen, a nonprofit consumer safety awareness group, submitted a petition representing more than 100,000 consumers seeking to ban NuvaRing. The FDA took action again in 2011, when it released a drug safety report referencing a study of 800,000 women using NuvaRing. The study showed that the risk of venous thrombosis — blood clots that can form in the veins and travel to the lungs — increased substantially for NuvaRing users compared with non-users of hormonal contraception.
More than 1,000 women sued Organon and Merck after suffering serious side effects from NuvaRing.
INFUSE Bone Graft
Doctors use INFUSE bone grafts in spinal fusions for people with arthritis or other types of degenerative bone disease. The grafts are used about 100,000 times a year in the United States and are intended to relieve discomfort. However, they sometimes lead to side effects like severe back pain, difficulty breathing, leg pain and implant failure.
The U.S. Senate scrutinized trials by Medtronic, the manufacturer of the grafts. The Senate found the approved uses come with hazards the company withheld from the public. Health officials and other doctors accused Medtronic of paying researchers millions of dollars in consultation fees and providing vacations in order to sway their opinion and entice them to conceal side effects. The company paid $40 million in 2006 to settle a civil case regarding these issues, and then was investigated again in 2011.
In 2008, the FDA alerted health care providers that using the INFUSE bone grafts for unapproved purposes could result in life-threatening complications. The alert noted that unapproved use might cause swelling of the neck and throat, resulting in problems with speaking, swallowing and breathing.
Hundreds of people sent reports of adverse events to the FDA related to INFUSE grafts. People suffering from graft injuries filed lawsuits against Medtronic, accusing it of intentionally withholding reports of adverse events.