FDA to Examine Increase in Failed Robotic Surgeries

 The use of robotic surgeries is getting a second look by the Food and Drug Administration as the number of reported incidences in 2012 has tripled since 2008. With over 1,400 hospitals nationwide deploying a surgical robot to assist in soft tissue surgery, neurosurgery and orthopedic procedures, complications have been documented at a higher than acceptable rate that has garnered the FDA’s attention. What is unknown at this point is if the failure is attributable to the robot itself, operator error, the FDA marketing clearance process, or the training provided by the manufacturers. As with any surgery, complications can occur and the FDA’s focus will make a further determination in this matter and offer industry guidance

An upcoming research paper from a Johns Hopkins University author and patient safety expert may be the catalyst for the timing of the FDA’s initiatives. Dr. Martin Makary, a surgeon and article co-author, says that many robotic surgery complaints are under-reported and some have catastrophic complications. Dr. Makary’s online profile says that he serves jointly on the faculty of the Johns Hopkins School of Medicine and School of Public Health where he additionally takes on active leadership roles for the United Nations World Health Organization (WHO), the International Union of Risk Management, and is a regular medical guest on CNN.

A large national study conducted by Medicare and published in 2010 questioned the results of the procedures but did agree with shortened hospital stays post operatively as a benefit to Medicare budgets. Critics of the study said that Medicare failed to cite data from centers of excellence. Conversely, opponents of surgical, computer-assisted surgery state that when a study only cites centers of excellence in its surveys, the findings do not reflect “real world” results, thus, the published results can be misleading to the public. However, advocates in both camps do agree that training is the deciding factor in the learning curve.

Mr. James Gibson, President of Integrity Life Sciences, weighed in on the controversial surgical debate and said, “There is clearly a place for surgery in the continuum of care just as there is a movement for alternative therapies”. He also added, “When it comes to nationally published clinical data that is widely distributed as patient education materials, there is often a general misconception that results from clinical centers of excellence are easily replicated on a localized level by neighborhood physicians.”

Non-surgical spinal decompression is a constructive therapy and not destructive or invasive and it continues to remain one of the safest alternatives to back surgery, traditional or robotic. With years of clinical data on non surgical decompression from everyday treating physicians, to those from the halls of esteemed academic institutions, replicating results have been easily achieved.

Integrity Life Sciences delivers a multitude of orthotic treatment options to address one of the most costly systemic ailments in the world, chronic low back and neck pain. The advanced solution begins with the Integrity Spinal Care System. Integrity’s medical devices are non-surgical spinal decompression therapy systems engineered to provide pain relief for compressive and degenerative conditions of the spine. Specifically, conditions that may be treated include: neck pain and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

Additionally, Integrity offers the very effective Integrity Gel Support Brace. The Integrity Gel Support Brace is a lumbar support brace that is a fitting compliment to non-surgical spinal decompression. The Integrity Gel Support Brace was designed as an adjunct therapy for those suffering from back pain and with the back pain sufferer’s needs in mind. The Integrity Gel Support Brace can be used with or without Integrity’s non-surgical spinal decompression medical devices, and is an excellent treatment option for personal home use.

Team Integrity is guided by the leadership of Mr. James Gibson and a staff of managers, engineers, technicians, quality and regulatory approval professionals with a cumulative 50 plus year track record in the health care industry with specific demonstrated success in the global Non Surgical Spinal Decompression Industry. Integrity Life Sciences manufactures its products with quality and safety standards as demonstrated by its ISO 13485 registered quality system with TUV, SUD and the CE mark affixed to its product. Our FDA clearance together with compliance to global harmonized standards of both Mark CE and ISO 13485 allows Integrity Life Sciences to distribute to countries all over the world. As the owner of multiple US Patents, Integrity Life Sciences is committed to ongoing research and development in support of the worldwide healthcare community.

Prior to Integrity Life Sciences, Mr. Gibson founded Axiom Worldwide, Inc in 2001 and obtained multiple US FDA 510(k) clearances over the years. Axiom invented its flagship products, the DRX9000 True Non-surgical Spinal Decompression System and the DRX9000C, for use in medical markets around the globe. The DRX 9000 and the DRX9000 C were created to provide relief of back and neck pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, and sciatica. The dedicated team at Integrity Life Sciences will continue to support legacy devices while pursuing continued medical innovations throughout the world.

Integrity Life Sciences is a privately held USA based company with international partners located across the globe with a mission of “Restoring Integrity to the Spine”.

Company Name: Integrity Life Sciences, LLC
Contact Person: James Gibson
Email: Send Email
Phone: 813-935-5500
Address:2189 West Busch Boulevard
City: Tampa
State: FL 33612
Country: United States
Website: www.IntegrityLifeSciences.com