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Faulty medical implants and devices are causing massive harm to patients across the world, a new report reveals, prompting an overhaul in regulation in the United States. The scale of the problem comes as no surprise to our Virginia defective device attorneys. However, we are appalled at the scale of the problem and how big pharma is putting profit before patient safety.
This month, news outlets published damning investigations into the failures of numerous medical devices.
Alarmingly, an accelerated review process used by the U.S. Food and Drug Administration (FDA) failed to identify faulty implants and devices and placed consumers at additional risk.
The FDA is overhauling its controversial expedited approval process following thousands of faulty medical device lawsuits. The regulator says it decided to take action before the new report was published.
Ever since 1976, manufacturers of medical devices have taken advantage of an expedited approval process known as 510(k). It meant they could grandfather in new products with minimal testing if they were similar to those already on the market.
This month’s investigation highlights the shortcomings of the system. Lax rules and a startling lack of transparency led to complications with medical devices including metal-on-metal hips, pacemakers, contraceptives, breast implants, and surgical mesh products.
The research from over 250 journalists found the FDA collected about 5.4 million “adverse event” reports in a decade. These reports included 1.7 million injuries and almost 83,000 deaths from dangerous medical devices. In about 500,000 cases, surgery was needed to correct a problem caused by a device.
In updating the controversial 510(k) approval process, the FDA is seeking to stop pharmaceutical companies basing new products on devices that are over 10 years old.
CNBC reported the FDA cleared 3,173 devices through the 510(k) approval system last year. That was more than 80 percent of all devices cleared or approved. Nearly one-in-five of all products cleared through 510(k) are based on a device that’s over a decade old.
How 510(K) Process Led to More Faulty Medical Implants and Devices
We have been alarmed for some time about untested medical devices being used on patients in Virginia and elsewhere.
The ease big companies get their products on the market is unnerving. Consumer Reports noted the manufacturers often do little more than file paperwork and pay the FDA about $4,000 to start selling a product that can quickly net millions of dollars.
The people who receive these devices become human guinea pigs. The disaster of metal-on-metal hips is a case in point. Thousands of people suffered pain and contamination from metal in these devices. Companies like Johnson & Johnson ended up settling cases for $2.5 billion.
Sadly, for big pharma, legal verdicts are part of the cost of doing business. A report published this week claimed one big drug company knew of the risks of a medical device before putting it on the market to unsuspecting women.
Recent reports claim a big drug company put a popular product on the market after it became aware of the risks.
The Guardian newspaper examined claims that Johnson & Johnson knew about a defective vaginal mesh implant that left thousands of women in excruciating pain before it even went on the market.
Internal emails suggested J&J executives were briefed on the flaws of transvaginal mesh. They knew the product could become rigid and inflict serious pain on women.
The report suggested executives were aware of the transvaginal mesh complications in May 2004 before the product was launched. One senior staff member warned the company the mesh could become hard and cause pain.
Notwithstanding the dire warnings, the device was launched months later. It was vigorously marketed over seven years, according to media reports.
Mesh is often used to treat pelvic organ prolapse. A similar product used for hernia repair has also sparked lawsuits. Vaginal mesh is usually implanted at the time of a hysterectomy or as a separate surgery.
Mesh has become embedded in body tissues causing severe pain. It is linked to damage to the organs, bowel and bladder perforation and other serious complications.
More than 65,000 transvaginal mesh lawsuits have been filed against manufacturers including C.R. Bard, Ethicon (a Johnson & Johnson subsidiary), American Medical Systems, and Boston Scientific.
The vaginal mesh was approved under the discredited 510(k) system. We are appalled women suffered so much unnecessary pain, permanent injury, and even death over this dangerous medical device.
Patients who have been harmed by faulty medical implants and devices may have suffered very serious injuries. You should consider lawsuits against big pharma. Mass tort lawsuits are progressing over devices such as IVC filters, Physiomesh and birth control devices like Essure that Bayer pulled off the market this year.
A Virginia defective medical devices lawyer can advise you of your rights and include you in a lawsuit. Please call us at (757) 455-0077 as soon as possible.