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Sometimes a medical device meant to provide relief for patients suffering and expedite healing causes more pain than relief. One of these devices is known as a pain pump, most commonly used in patients recovering from shoulder surgery after a serious shoulder injury. According to the New York Times, these devices became popular in the late 1990s because they allowed patients to leave the hospital earlier while they received narcotic painkillers for recovery through the pump. While the pain pumps had received clearance from the U.S. Food and Drug Administration, the FDA had never cleared the devices for use in joints.

It was not long until several young patients returned to their surgeons suffering from chondrolysis, a rare ailment in which the cartilage dies, precipitating the painful condition of a bone grinding on an adjacent bone. One orthopedic surgeon told the Times that he had lost many hours of sleep trying to figure out what was causing the chondrolysis before several medical studies identified pain pumps as a likely culprit.

Throughout 2010 and 2011, hundreds of lawsuits were filed against the manufacturer of one widely implemented pain pump, I-Flow Corporation. The company was ordered to pay millions of dollars in settlements to patients who had experienced negative side effects, many who had to have shoulder joints entirely replaced. The FDA issued a warning discouraging the use of pain pumps in joints, and required manufacturers of anesthetics to change labels, encouraging doctors not to use such anesthetics through pain pumps.


Surgical mesh was developed in the mid-20th century as a way to treat hernias. The implant was originally intended to be placed beneath the skin to patch the hole in the abdomen and block intestines and other tissues from protruding, according to the U.S. Food and Drug Administration. It can be made from either biological or synthetic materials. Recently, manufacturers of surgical mesh began marketing it as a means to prevent organ prolapse into the vaginas of women. It can be implanted after a hysterectomy or as a separate procedure. Women often experience a weakening of pelvic muscles after pregnancy and childbirth, which can lead to organ prolapse. About one-third of surgeries performed to prevent organ prolapse in women in 2010 used transvaginal mesh as a means to prevent further prolapse.

It may seem a wonder procedure, but the procedure of implantation and the implant itself can have so many negative side effects it may not be the best cure. According to a Bloomberg wire article published in The Daily Record, one manufacturer, Endo Health Solutions Inc., was ordered earlier this year to pay $830 million in damages to resolve lawsuits brought against it by women who had undergone a transvaginal mesh implant procedure. Women allege that the implant “failed to support internal organs and caused incontinence,” according to The Daily Record.

This September a federal jury in the West Virginia court ordered Johnson & Johnson, one manufacturer of defective transvaginal mesh devices, to pay one woman $3.27 million in damages for permanent injuries she sustained after having one of Johnson & Johnson's transvaginal mesh devices implanted. This is not the first verdict brought against the medical device manufacturing giant: earlier this year, a Texas state jury ruled in favor of a transvaginal mesh suit defendant. She was awarded $1.2 million for alleged damages caused by the TV-O sling manufactured by Johnson & Johnson, according to an article published by Bloomberg wire service. Before the Texas verdict, an even larger settlement was reached in New Jersey, when a Jersey jury awarded more than $11 million to a woman who underwent 18 surgeries in an attempt to fix complications from a Gynecare Prolift device.


When complicated medical technology hits the market and is adopted by medical professionals, issues with associated surgeries are bound to occur. There are several reasons for this, and difficulties with the manufacturing of the product itself are not the only ones. By some reports, the U.S. Food and Drug Administration (FDA) does not always fully vet products before they are released to the public. Hence, many devices end up recalled. According to The Wall Street Journal, the number of recalled devices continues to increase each year, and have in fact increased by almost 50 percent between 2003 and 2012.

Manufacturer recalls, not mandated by the FDA, often come too late to those who have already used the recalled device. One such example occurred in 2007 via the Metronic recall of defibrillator wires. These wires had been implanted in more than a quarter-million patients before the recall was issued, and thus resulted in a handful of patient deaths. However, Wanda Moebius, a senior vice president at the industry trade group AdvaMed, told The Wall Street Journal that medical device companies are taking a more patient-centric and cautious approach to FDA reporting.

Steve Silverman, director of the FDA medical device center's office of compliance also noted to The Wall Street Journal that the number of recalled products lags behind the number of medical devices that hit the market during the same time period. “The FDA said the numbers of medical devices increased by about 25 percent from 2008 to 2012.” While this may be true, many critics of the increased number of recalls claim how a more rigorous or thorough review of products could help to decrease the number of annual product recalls, as well as the dangers associated with them.


In August, two U.S. senators began pressing the Food and Drug Administration (FDA) to take power morcellators off the American medical device market. According to the FDA, laparoscopic power morcellators are used to help remove tissue through small incision sites, and are most commonly used in hysterectomies or during the surgical removal of uterine fibroids (myomectomy).

The FDA clearly states that when used for either purpose, the morcellators “poses a risk of spreading unsuspected cancerous tissue” beyond the uterus and into the bloodstream. As such, the agency discourages the use of morcellators but does not outright forbid their implementation. This is what New York Senators Chuck Schumer and Kirsten Gillibrand are attempting to quell.

According to an article in Modern Heathcare, in August Senators Schumer and Gillibrand wrote a letter to the FDA requesting that the agency to remove the morcellator devices from the market. The letter, reports Modern Healthcare, cites a recent survey done at Boston's Brigham and Women's Hospital which found that women who had morcellators implemented were at a nine times higher risk of having the cancer spread than what was communicated to them at the time of surgery.


Bayer Healthcare Pharmaceuticals, a manufacturer of Mirena Intrauterine Devices (IUD) birth control, has faced several lawsuits in recent years for alleged complications that arise from having used the device. Earlier this month, Mirena made headlines in Bergen County, New Jersey, where nearly 1,000 new lawsuits were filed to date against the manufacturer. The lawsuits allege serious injuries due to “spontaneous migration of the IUD” in those who had the device implanted. Noted injuries include “uterine perforations, organ damage, scarring, and infertility.” There are an additional 600 similar lawsuits pending in southern New York.

An intrauterine device is a long-term contraceptive that is implanted into a woman's uterus. It can only be implanted by a certified medical provider, and has been in use since it was approved by the Food and Drug Administration (FDA) in 2000. It was not until nine years later that the device was approved for use in women with extreme heavy menstrual bleeding. That same year, however, the FDA warned Bayer that their promotion of the intrauterine device did not adequately warn patients of the risks and overstated the benefits of using this type of birth control.

According to WebMD, disadvantages of the hormonal intrauterine device include the increased possibilities of ovarian cysts. These are noncancerous (benign) and tend to go away without the assistance of a medical professional. There are also hormonal side effects to a hormonal intrauterine device, which are similar to those experienced by women who use birth control pills. These can include acne, headaches, mood swings, and breast tenderness. Unlike many women who take birth control pills report, however, side effects such as these experienced by women who have a hormonal intrauterine device tend to go away after the first few months of use.

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