Devices

FDA Warns Doctor on Breast Augmentation Pocket

David McFarland

— 3 min read
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In a 2/13 Warning Letter, FDA says Dr. Mark Berman, Beverly Hills, CA, has been manufacturing a medical device known as the Pocket Protector, an expanded-polytetrafluoroethylene pouch used to line the inside of a breast pocket during breast augmentation procedures. The letter cites many of the marketing claims made for the device and says the agency “is not aware of an implantable device intended for use with breast implants, such as yours, that is legally marketed for this use. Therefore, FDA has determined that your device requires premarket approval as a Class 3 device.”

Because Berman does not have an approved PMA or IDE in effect, the device is adulterated, the agency says. The letter acknowledges Berman’s claim that his device qualifies for a custom device exemption, and explains why FDA disagrees with that conclusion.

The letter says the exemption is for a narrow category of devices for which, due to the rarity of a patient’s medical condition or physician’s special need, compliance with premarket review requirements and performance standards is impractical. It says the law requires that exempt devices be limited to production of no more than five units per year and that manufacturers submit annual reports to FDA on the custom devices supplied.

FDA says that based on its inspection observations and Berman’s responses to the observations, the Pocket Protector does not qualify for an exemption since Berman failed to submit annual reports to FDA and in some years produced more than five units.

Berman also is cited for the following Quality System Regulation violations: 

  •          failing to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
  •          failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
  •          failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;
  •          failing to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedures;
  •          failing to establish procedures for acceptance activities;
  •          failing to establish and maintain procedures to control product that does not conform to specified requirements;
  •          failing to establish and maintain procedures for implementing corrective and preventive action;
  •          failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  •          failing to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record;
  •          failing to maintain a device master record;
  •          failing to establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, deterioration, contamination, or other adverse effects pending use or distribution;
  •          failing to establish procedures for management review;
  •          failing to establish procedures for quality audits; and
  •          failing to establish procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned responsibilities.

FDA says Berman’s response to the investigators’ observations was not adequate because it did not provide any evidence that corrective actions are being undertaken to address the violations.

He was told to immediately stop distributing the Pocket Protector and to take prompt action to correct the violations in the letter. He also was told to respond with a list of specific actions taken to correct the violations and prevent their recurrence, with documentation of each corrective action and a timetable for completion.

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