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www.fdanews.com/articles/14533-surgisil-warned-for-unapproved-marketing-of-facial-implant

Surgisil Warned for Unapproved Marketing of Facial Implant

May 10, 2019

Plano, Texas devicemaker Surgisil is in hot water with the FDA over its Perma Facial Implant, a device that is only cleared for cosmetic facial augmentation and augmentations in areas like the nose, chin and cheeks.

The agency sent a warning letter after a September 2018 inspection, flagging the marketing of the implant for an unapproved use. The agency said the device was “intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear,” but the company was marketing its Permalip implant for lip augmentation.

Lip augmentation “constitutes a major change/modification to its intended use” for which the firm lacked approval, the agency said. It warned that use of the PermaLip Implant in lip augmentation could cause the device to shift out of place or protrude due to the lips’ anatomical and physiological differences from the nose, cheeks and skin, warning that infections, chronic pain and the need for surgical removal could follow.

The agency’s investigators examined the company’s instructional videos and marketing materials on its website, finding that they misled patients into believing the device could be used for the unapproved use. For example, the firm’s three-minute facial implant instructional video covered the use of the facial implant in lip augmentation.

The agency also flagged a 12-item surgical checklist that instructed surgeons on using the facial implant, included a procedure for lip augmentation.

The FDA noted that the firm’s website stated the implant is an “FDA approved device” and requested that it remove the false claim.

“The PermaLip Implant is not cleared or approved by FDA for marketing in the United States,” the agency said. “Our office requests that your firm immediately cease activities that result in the misbranding or adulteration of the Permalip Implant, such as the commercial distribution of the device for the uses discussed above.”

Read the Surgisil warning letter here: www.fdanews.com/05-09-19-Surgisil.pdf. — James Miessler

Personnel Requirements for CAPAs

Companies putting together CAPA teams need to assign the following individuals:

  • CAPA manager: This is the person in the company who is responsible for the overall CAPA system, including coordinating all CAPA activities and taking a role in investigations of nonconformances and other quality problems;
  • Process owner: For each of the processes and data elements/sources that the company tracks, the company will need a process owner. Having process owners from the departments that actually conduct those processes will improve the quality of the data received and increase buy in to the CAPA process. This is important because one of the keys to CAPA success is breaking down “silos” and expanding participation beyond the quality team using a collaborative, cross-functional approach. The company should set regular planning, strategy and review meetings involving owners, team members and management;
  • CAPA owner: Once a nonconformity or other problem is found, the company must assign it to a CAPA owner. This person will be responsible for coordinating a team to investigate the problem and then develop and implement a plan to correct the problem and prevent it from recurring; and
  • CAPA monitor: The company should designate someone, such as the CAPA owner, to use trending techniques to catch—and address—quality problems early and to monitor ongoing process performance and the effectiveness of the CAPA plan.

Excerpted from the FDAnews management report: Creating QSR-Compliant CAPA Systems: A Practical Guide for Devicemakers.