0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Invited Commentary |

Balancing Innovation and Value of Biological Meshes in Hernia Who Is in Charge?

Benjamin K. Poulose, MD, MPH1; Brent D. Matthews, MD2; Michael J. Rosen, MD3
[+] Author Affiliations
1Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee
2Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina
3Department of Surgery, The Cleveland Clinic, Cleveland, Ohio
JAMA Surg. 2016;151(4):381-382. doi:10.1001/jamasurg.2015.5236.
Text Size: A A A
Published online

Extract

The work by Huerta et al1 in this issue of JAMA Surgery highlights a fundamental problem in surgery: balancing the need for innovation with the practicalities of demonstrating clinical benefit for novel ideas. This issue is particularly timely given an unsustainable trajectory of health care spending in the United States.2 The authors link the use of high-cost biological meshes with a regulatory approval process based on the predicate device concept. The premarket notification (510k process) is used to obtain marketing clearance for a device that is largely equivalent in safety and effectiveness to another marketed device or to a standard recognized by the US Food and Drug Administration (FDA) when used for the same intended purpose. However, most hernia mesh products are marketed aggressively, purporting individual advantages with generally poor data to substantiate these claims. The current fiscal climate of hospitals (who bear the brunt of additional mesh costs) will likely limit the use of products that have no potential benefit to patients compared with less costly alternatives. This is a reasonable fiscal approach, but potential clinical benefits of innovative technologies may go undiscovered.

First Page Preview

View Large
First page PDF preview

Figures

Tables

References

Correspondence

CME
Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

Multimedia

Some tools below are only available to our subscribers or users with an online account.

357 Views
1 Citations
×

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
Jobs
brightcove.createExperiences();