FDA Proposes Changes to 510(K) Medical Device Approval Process

The Attune Knee System was approved through the FDA’s 510(K) process. Breakstone, White & Gluck is currently representing patients who have suffered Attune knee replacement failures. Free Consultation: 800-379-1244.

In 2019, the public can expect to learn more about the Food and Drug Administration (FDA)’s plans for improving the 510(K) approval process for medical devices. Instead of improving the quality of life for patients, too many medical devices are causing injuries and even death. Many of these medical devices were been approved through 510(K).

Too often, we hear about medical device injuries in the news. At Breakstone, White & Gluck, our attorneys represent patients injured by defective medical devices and other unsafe products in Massachusetts and Rhode Island, from Boston to Worcester to Providence. Our attorneys know each news story represents many more patients who have been injured.

But just how many? More than 1.7 million people have suffered injuries from medical device failures over the past decade, according to a 2018 Associated Press report. Nearly 83,000 people died. These are giant and unbelievable numbers, especially when you consider that medical devices undergo a federal approval process which should protect patients.

How the FDA 510(K) Process Works

Since 1976, manufacturers have been able to short-cut the FDA approval process. If a manufacturer can demonstrate their medical device is “substantially equivalent” to an approved medical device, they can apply through the 510(K) approval process. The manufacturer has to submit paperwork, explaining the similarities between medical devices, but they are not required to conduct additional clinical testing – even for devices which are surgically implanted such as knee and hip replacements.

FDA Proposal Calls for 10-Year Restriction

While the FDA has long been committed to the 510(K) approval process, many have argued the process needs to be more focused on patient safety. After many years of complaints, the FDA is now proposing a change to only allow manufacturers to use the 510(K) approval process when they base their applications on medical devices approved in the past 10 years.

The FDA said this change will modernize the process and ensure products and technologies continue to improve.

Here is a point that supports change. While there are 4,000 medical devices in the agency’s database, just six types have caused 25 percent of all injuries between 2008 and 2017. These include defective hip replacements, including the DePuy metal-on-metal and other hip implants, accounting for more than 103,000 injury reports. The other medical devices: spinal stimulators, surgical mesh, defibrillators, implanted insulin pumps and insulin pumps with sensors. These figures also come from the Associated Press.

Over the next few months, the FDA is taking public comment on other questions, such as should there be a public list of devices or manufacturers who make technologies that rely on devices approved more than 10 years ago? Or what would be an appropriate time period? Read more: FDA’s questions for the public.

Common Medical Device Defects and Injuries

Breakstone, White & Gluck specializes in representing those injured by medical device failures in Boston, Worcester and across Massachusetts and Rhode Island. If you have been injured, our attorneys can advise you of your legal rights for seeking compensation. Our goal is to help clients obtain prompt medical treatment and then, full compensation for financial losses, such as lost wages. Patients may also be entitled to damages for pain and suffering.

Our lawyers are experienced in handling medical device claims involving:

Knee implants. One knee replacement with a high rate of failure is the Attune Knee System, which is stabilized by a cement fixture. Patients can suffer physical pain when the cement loosens.

Hip implants. DePuy issued a recall for its ASR XL Acetabular System metal-on-metal hip implants in 2010. But many other implants followed, including the Stryker Rejuvate Modular and ABG II Modular-Neck Hip Stems, Zimmer and Smith & Nephew. Read more about what to do if you have a defective hip implant.

Surgical mesh. Patients have suffered complications after being treated with surgical mesh implants during hernia repair procedures. There have been so many injuries that the FDA has issued an advisory warning patients about the severe pain and long-term complications that can result. One type of surgical mesh which has caused injuries is the Ethicon Physiomesh® Flexible Composite hernia mesh.

Boston Medical Device Injury Lawyers – Free Legal Consultation: 800-379-1244

Learn your legal rights if you have been injured as a result of a medical device failure. For a free legal consultation, contact Breakstone, White & Gluck at 800-379-1244 or 617-723-7676 or use our contact form.

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FDA Considers Next Step for Transvaginal Mesh, Medical Device Approvals

A Food and Drug Administration (FDA) advisory panel has recommended that some transvaginal mesh products be reclassified as the process for approving mesh and other medical devices comes under scrutiny.

On July 13, the FDA updated a 2008 public health notification, reporting that complications from transvaginal mesh are not rare and that it is not clear that transvaginal mesh surgery is more effective than non-mesh repair of pelvic organ prolapse (POP). Having received over 3,800 reports of complications, the FDA urged surgeons to consider other options before performing transvaginal mesh surgery.

Since then, more than 600 women have filed lawsuits over complications from transvaginal mesh, which is surgically implanted to treat both POP and stress urinary incontinence (SUI). POP occurs when a women’s pelvic muscles and organs are weakened and stretched, often after child birth or hysterectomies.

Women reported painful complications such as internal mesh erosion, pain during intercourse, infection, bleeding, organ perforation and urinary problems. Corrective surgery is often required and is not always successful. In one report by Bloomberg News, a woman reported she had undergone 17 procedures to reverse damage from transvaginal mesh, including five surgeries, and is still suffering from the condition.

The FDA approved the first transvaginal mesh product, ProtoGen by Boston Scientific, in 1996. Two years later, Johnson & Johnson won approval for a similar device called Gynecare VT, but was not required to conduct human testing on it. Using the FDA’s 510(k) process for medical devices, Johnson & Johnson was allowed to bypass testing by claiming the device was “substantially equivalent” to the Boston Scientific mesh product.

The FDA approves 90 percent of medical devices under the 510(k) process, including defective hip implants and external heart defibrillators that have been subject to recalls in recent years.

Critics say the 510(k) process is flawed and needs to be overhauled. In the case of Boston Scientific, the Massachusetts manufacturer recalled its surgical mesh product in 1999 as other companies were just starting to bring their product to market. There are a total of nine manufacturers of transvaginal mesh products.

In January, the FDA announced it was considering 25 changes to the 510(k) system. In July, the non-profit U.S. Institute of Medicine issued a warning about it and Congress has pushed the FDA to make changes.

As for transvaginal mesh, the FDA convened an advisory panel to review the safety of the medical device in September. The 17-member panel recommended that some transvaginal mesh be reclassified as high-risk devices and require new studies be conducted to stay on the market. The FDA has yet to make a decision.
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