According to a report from Newsinferno, Medtronic aggressively attempted to contain proof that Infuse (rhBMP-2)—specifically when used in unapproved medical procedures—is the culprit in numerous health issues, including cancer. It seems that prior to its approval in 2002, Medtronic paid surgeons very generously to provide research pointing to the product’s safety and, when research indicated that Infuse was linked to complications, Medtronic suppressed that research.

Although what had long been believed to be medically sound research indicating that Infuse was an effective bone growth product, was, in reality, not. Infuse has proven anything but safe and concern is high among surgeons not paid by Medtronic, that Infuse is, in truth, dangerous. The U.S. Food and Drug Administration (FDA), to date, has received at least 280 reports of serious complications linked to Infuse and lawsuits against Medtronic accuse the company of its dangers. The lawsuits allege Infuse has the potetial to cause serious complications, including unwanted bone growth, cancer, and sterility in male patients.

Medtronic has also been accused of pushing Infuse for off-label procedure like neck surgeries, which would be illegal. Patients who undewent such procedures sometimes suffered severe neck and throat swelling, breathing and speaking problems, and airway compression. In 2008, a growing number of such reports prompted the FDA to issue a warning about off-lable use of Infuse.

This past November, Infuse became mired in even more controversy after Standford University spine researcher, Dr. Eugene Carragee, presented a study at the North American Spine Society that raised serious questions about a possible association between rhBMP-2 and an increased risk of cancer. According to Carragee, his analysis of a Medtronic study for its Amplify product, a higher-dose version of Infuse, found that the researches failed to identify a significant cancer risk. While the FDA ultimately refused to approve Infuse, Carregee said his findings have important implications for Infuse, as doctors often administer Infuse off-label at doses equal to or higher than what is found in Amplify.

With Infuse sales dropping due to the controversies, Medtronic commissioned researchers Yale University to independently review Infuse data, said Med City News. And, while outcomes are highly anticipated by Omar Ishrak, Medtronic CEO, in the hopes he will see vindication for his controversial blockbuster product, at least one research analyst does not see increased sales in Infuse’s future, even if Yale reviewers deem it safe.

“Given that we’ve already had the proverbial eyebrow raised about Infuse, will they go back to it, I don’t think so,” said Caroline Corner, an analyst with investment bank MLV & Co. who does not cover Medtronic, wrote Med City News.

Corner holds a PhD in biological and environmental engineering from Cornell University. According to Comer, talks with leading spine surgeons nationwide indicate that Infuse may continue to be used, but in a lesser capacity, for instance, in older people whose risk for cancer is decreased as well as hard-to-treat patients, according to Med City News.

“Someone who is a very poor healer, someone who is in a revisional surgery, someone who is older and not in child-bearing age … some doctors still see an (Infuse) application in treating these hard -to-treat people,” Corner said. “But doctors, in general, are definitely shying away from using Infuse (most of the time),” which increases opportunities for an alternative to Infuse, said Comer, wrote Med City News.

According to research, said The Telegraph, medical regulators in the U.K. issued new advice for the more than 40,000 Britons implanted with the devices amid concerns that metal-on-metal devices are more dangerous than first believed.

Adverse reaction reports and research reveal that when the metal components of, say a hip device, experience normal friction—the type typically found when the device’s metal ball and its metal cup connect during activities such as walking—metal shards can break off and travel throughout the body, affecting blood levels, causing inflammation, and damaging muscle and bones.

As NewsInferno explained, Britain’s health regulators are particularly worried about Johnson & Johnson’s DePuy unit’s ASR hip implants and other all-metal devices and their likelihood of creating more damage than first believed. For instance, noted NewsInferno, the device could elevate blood cobalt and chromium levels, which could lead to toxicity in the kidneys, and can be passed from pregnant women to their unborn babies. The Telegraph also pointed out that the fragments could pose risks to the nervous system, the heart, and the lungs, due to long-term poisoning.

Although problems with the devices affect people in all age ranges, research has found that younger and more petite women are at greater risk, said The Telegraph. Regardless, all patients implanted with all metal devices are advised to undergo annual testing, including scans and blood tests to ensure they are not suffering from the effects of metal leakage. And, now, the U.K.’s Medicines and Healthcare products Regulatory Agency’s (MHRA) advisors seeking more stringent advice over concerns the devices could cause “systemic toxicity” in the body, said The Telegraph.

Emerging research reveals that some hip replacements previously withdrawn from the U.K. market have much greater failure rates that previously released—up to 50 percent within six years, said The Telegraph. And, a conference of senior surgeons described the metal-on-metal implant situation as “frightening,” citing the growing number of patients suffering from tissue reactions and “component failure of catastrophic proportions,” said The Telegraph.

Metal-on-metal implants were introduced in the U.K. in the 1990s and, today, of the 40,000 U.K. patients who received implants, 10,000 were implanted with two types of DePuy devices taken off the market in 2010 over significantly high and unexpected 12-13 percent failure rates in the first five years of receiving the devices. That figure has grown, according to the Sunday Telegraph, which has reported failure rates of up to 50 percent in the first six years for patients who underwent full hip replacement.

Representative Henry Waxman (Democrat-California) and three fellow lawmakers have asked key Republicans in the House Energy and Commerce Committee to hold the hearing and order involved device makers to provide documentation, said Bloomberg News. The timing of the request is significant given that Congress is considering a U.S. Food and Drug Administration (FDA) overhaul of medical device rules, said Democratic lawmakers in a statement.

Earlier this month, the agency mandated Johnson & Johnson and 32 other device makers to conduct safety studies of vaginal implants following reports of internal injuries to patients, said Bloomberg. Also, the Democratic group pointed out that studies indicate increased complication rates for Allergan’s Lap-Band device.

“The committee should hold hearings to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh,” Democrats said. “We need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks,” they added.

Of particular concern, according to the letter, regarding the Lap-Band, is that “Even in the face of these serious medical complications, Allergan, the manufacturer of the Lap-Band, is seeking to expand the use of the device in children and young adults … despite concerns among some physicians that the procedure is too drastic or ‘extreme’ for a young person’s developing body.” The group also cited a recently published study that revealed that nearly half of all patients implanted with the gastric Lap-Band either experienced no weight loss needed to undergo device removal after six years, with 40 percent suffering long-term complications, noted Bloomberg.

NewsInferno recently wrote that Lap-Band gastric banding complications continue to rise, citing a study about potential issues years after the surgery. The surgery involves band placement around the top of the stomach, which creates a small pouch for food that makes patients feel full after eating smaller portions. Gastric banding is used when non-surgical weight loss methods have failed.

Transvaginal mesh is a surgical treatment for Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in women, said NewsInferno. Thousands of women nationwide claim they’ve suffered and continue to suffer injuries because of defective transvaginal mesh devices. According to NewsInferno, transvaginal mesh has failed in one of several ways, typically eroding through the vaginal wall or skin, causing horrific pain; women complain of being unable to sit, stand, or lay in any position for more than a few minutes at a time. The FDA has received at least 1,500 reports in which a transvaginal mesh device failed to treat SUI or POP and, in the summer of 2011, the FDA issued a public safety notice about the growing number of incidents and the potential dangers of the devices, said NewsInferno.

“In 20I0 alone, nearly 300,000 synthetic vaginal meshes were implanted in American women. The most common complication associated with the device is erosion through the vagina, which can be potentially debilitating for some women and require multiple surgeries to correct. Even with multiple surgeries, some women are never able to recover from the damage,” the Democrats wrote. Meanwhile, according to the Democrats, said Bloomberg, Republicans continue to fail to respond to a request in October for a hearing on artificial hips and implanted brain stents that have also been linked to safety issues.

The recall involves all production lots for the Duet TRS Universal Straight and Articulating Single Use Loading Units that involve use of this product family in the thoracic cavity. To date, Covidien has received 13 reports of serious injuries and 3 reports of patient deaths following the application of Duet TRS in the thoracic cavity.

“After receiving reports connecting the use of the Duet TRS with patient deaths after thoracic surgery, we have made the decision that the product should not be used in such procedures,” said Bryan Hanson, Covidien’s Group President, Surgical Solutions. “Accordingly, we are advising our customers that the Duet TRS should not be used in thoracic surgery,” Hanson added.

Because of these incidents, Covidien concluded that its Duet TRS has the potential to injure adjacent anatomical structures within the thorax cavity and that this potential may result in life-threatening, post-operative complications, including death. The product codes and descriptions for the recalled devices are:

• DUET4535
• DUET4535A
• DUET4548
• DUET4548A
• DUET6035
• DUET6035A
• DUET6048
• DUET6048A
• DUET TRS 45 3.5MM STRAIGHT SULU
• DUET TRS 45 3.5MM ARTICULATING SULU
• DUET TRS 45 4.8MM STRAIGHT SULU
• DUET TRS 45 4.8MM ARTICULATING SULU
• DUET TRS 60 3.5MM STRAIGHT SULU
• DUET TRS 60 3.5MM ARTICULATING SULU
• DUET TRS 60 4.8MM STRAIGHT SULU
• DUET TRS 60 4.8MM ARTICULATING SULU

Covidien announced that it is collaborating with the FDA and other worldwide regulatory authorities to modify instructions for use of the Duet TRS Universal Straight and Articulating Single Use Loading Units so that the device is contraindicated for use in adult and pediatric thoracic procedures. Covidien also put a hold on its Duet TRS inventory, worldwide, to allow for the products to be relabeled with the revised usage instructions. Covidien said it is providing information to its customers on alternative tissue reinforcement products that may be used in conjunction with Covidien endoscopic staplers for thoracic surgery.

The Duet TRS is a single-use loading unit with a fully integrated tissue reinforcement system to support staple lines in tissues that was released in 2009. To date, more than 500,000 units have been sold worldwide and Covidien believes about one-third of all global procedures involve use of the Duet TRS are for thoracic indications. The Duet TRS will continue to be used for other indications, including abdominal procedures.

Customers have been notified of this recall by letter on January 12, 2012 and have been advised that the device, intended for thoracic use, must be returned by contacting Covidien Customer Service by email at SDFeedback@Covidien.com or, toll-free, at 1.800.722.8772, option 1, to obtain a Return Goods Authorization prior to returning the affected units. Customers may choose to retain the product for uses other than thoracic.

Recently health authorities in France advised about 30,000 women who received Poly Implant Prothese (PIP) silicone breast implants to have them removed over rupture risks. The debacle began following the death of a French woman who received PIP implants and developed rare aplastic large cell lymphoma (ALCL), said Reuters. The devices have not yet been definitively linked to cancer; however, no less than eight other cases of the rare ALCL have been reported among French women who received PIP implants. PIP is now defunct and is the focus of a French criminal investigation.

“Even if there is no rupture, it is advisable … to have the prosthesis removed,” the Dutch Health Inspectorate said in a statement, wrote Reuters. By year-end 2010, some 1,000 women in the Netherlands had received PIP implants, which were sold under the “M-implants” name, the statement noted; another 400 women had the implants removed at that time, as well, wrote Reuters.

The Dutch announcement is a reversal of the inspectorate’s original recommendation three weeks ago in which it urged women to have their implants checked by a physician, but did not call for removal of the devices, said Reuters. The changed recommendation followed advice from the Dutch plastic surgery association.

“The implants have an increased risk of rupturing or leaking and it is not clear whether there are physical reactions to the silicone in the long term,” the plastic surgery association said on its website. The association noted that this could include “a changing breast shape, pain, and the visibility of the capsule around the prosthesis,” according to Reuters.

PIP silicone breast implants, already one of the cheapest and most fragile available, were recalled last year after it was discovered that the devices contained industrial, not medical grade, silicone. Prior to the recall, PIP produced about 100,000 silicone implants annually. Now, fears about ruptures and cancer have other countries on high alert, including Brazil, Argentina, Britain, Germany, Spain, Italy, and Israel, said NewsInferno. About 2,000 French women have filed legal claims over the PIP breast implants as well as another 250 implant recipients in Britain.

In the United States, the PIP silicone breast implants were never approved for sale; however, PIP sold about 35,000 saline implants between 1996 and 2000. Those implants were the subject of a 2000 U.S. Food & Drug Administration (FDA) warning letter, and are also subject of product liability lawsuits in the U.S., filed by women alleging the devices deflated after several years.

A former official with the U.S. Food and Drug Administration (FDA) has joined Public Citizen and other advocacy groups in seeking the federal government’s withdrawal of the Stryker device, said Bloomberg Businessweek. According to Public Citizen, a recent National Institutes of Health- (NIH) funded study revealed that the Stryker Wingspan stent system was linked to a 2.5-fold increased risk for stroke or death, wrote Businessweek. The advocates filed their petition—co-signed by a former executive from the FDA’s device division—this Wednesday.

“I can see no reason why this device should continue to be available,” said Professor Larry Kessler, in a letter that accompanied the petition. Kessler worked at the FDA’s device division for more that 12 years and is, today, a professor of health science at the University of Washington, according to Businessweek.

Businessweek explained that the Wingspan, approved in 2005, received a quick approval meant for devices that treat rare diseases and conditions; Stryker acquired the Wingspan from Boston Scientific, its original manufacturer. The program, the FDA’s Humanitarian Device Exemption Program, enables devices to receive approval based on preliminary evidence as long a “reasonable basis” exists that finds the device’s benefits outweigh its risks.

Dr. Sidney Wolfe of Public Citizen said that by using this program, Boston Scientific, “was able to gain marketing approval based on a single, uncontrolled trial of just 45 patients that was not designed to demonstrate whether the device was more effective or even safer than medical therapy alone,” Businessweek reported. The Wingspan stent, approved for stroke patients at risk for a second or additional strokes, is a tiny, mesh, metal tube that is put in place in the brain’s narrowed arteries and inflated.

The study that prompted the Public Citizen petition was published in September’s New England Journal of Medicine, and revealed that patients treated with the stent were likelier to suffer a second stroke or die within one month, versus patients who received a combination of blood thinners. That study involved 158 stroke patients treated with Wingspan, whose progress was followed for six months; the group was compared to another group who only received drug therapy. The study was halted April in Adue to safety concerns.

“We hypothesized that stenting would be more effective than medical therapy and found exactly the opposite,” said Dr. Marc I. Chimowitz, lead researcher and professor of neurology at the Medical University of South Carolina, wrote USA Today, previously, concerning a brain stent study. “In this population, given the results of the study, I would recommend aggressive medical management,” he added.

Johnson & Johnson, C.R. Bard, Endo Pharmaceuticals Holding Inc., and Boston Scientific Corporation, among others, have just been ordered by the U.S. Food and Drug Administration (FDA) to study links between their vaginal mesh implant products and organ damage, infection, and painful sex rates, said Bloomberg News. Device makers—33 in all—received FDA letters this week, asking them to compile three years of data on implant safety and efficacy, William Maisel, deputy director of science for the FDA’s device-approval center, told Bloomberg News.

The move followed an FDA report this summer in which a five-fold increase was seen in transvaginal mesh deaths, injuries, and malfunctions, said Bloomberg News. According to NewsInferno, the FDA warned that the devices were linked to serious and painful complications, specifically when used in pelvic organ prolapse (POP) repair. At that time, the FDA said it had received over 2,800 complaints about transvaginal mesh complications since its warning in 2008; women died in three of those cases.

POP occurs when pelvic floor muscles supporting the uterus, bladder, urethra, small intestine, rectum, and the top of the vagina are weakened due to childbirth and other issues. POP can cause no symptoms or can cause pelvic pressure, lower back pain, urinary incontinence, sexual difficulties, or bowel movement issues, said NewsInferno. Some 350,000 women undergo surgery for POP in the U.S. every year.

Transvaginal mesh is a “hammock-like” device that is surgically threaded in the body via a vaginal incision, explained Bloomberg News. According to the FDA this July, studies could not clearly confirm if the devices offered increased benefits over older treatments; however, mesh devices have been linked to mesh fiber edges constricting or cutting into internal organs after implantation, as well as infection, according to studies, said Bloomberg News.