WARNING LETTER
CMS # 562321

UNITED PARCEL SERVICE
OVERNIGHT DELIVERY

February 13, 2019

Mark Berman, M.D.
120 S Spalding Dr. Ste 300
Beverly Hills, CA, 90212‐1837

Dear Dr. Berman:

During an inspection of your firm located at 120 S. Spalding Dr., Ste. 300, Beverly Hills, CA 90212, on July 9-13, 2018, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Pocket Protector, a pouch made of (b)(4) of expanded-polytetrafluroethylene bonded together by (b)(4) that is used for lining the inside of a breast pocket during breast augmentation procedures. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

The FDA has reviewed your firm’s website (www.markbermanmd.com), which revealed that your firm is marketing the Pocket Protector with indications and claims including, but not limited to, the following (underlined emphasis added):

Breast Augmentation Webpage1

• “Finally, Dr. Berman can provide his patients with the Pocket Protector® - a patented device he invented that can be used to repair breasts with capsule contracture or even used in first time augmentation.”

• “The Pocket Protector® is made from the same material as Gore-Tex® - e-PTFE (expanded-PolyTetraFluoroEthylene) - and shaped into a bladder. It's placed under the breast or the muscle (i.e. the pocket) and serves to line that space, keeping it from scarring back down upon itself and contracting around the implant. While this material has been used in general and vascular surgery for many years, it was first introduced into cosmetic/plastic surgery in 1983 (by me) and is still commonly used. The material is microporous and the body actually grows blood vessels and connective tissue into the material without forming a scar around it (except in cases of significant tissue injury). Within three months, there's no tissue reaction to the material and it is safely incorporated into one's body essentially as a synthetic scar. Many of the patients that have been successfully treated have had multiple failed operations prior to successful repair with the Pocket Protector®.”

Video with Mark Berman, M.D. on “The Wellness Hour”2

• “. . . Once they [people] find out about the Pocket Protector, they realize it’s kind of an insurance policy. It allows them to have a very soft natural breast. It allows them to put any of their smooth gel or smooth saline implant. It feels more soft and natural. It can stay on top of the muscle so they don’t have to have a painful operation putting the implant underneath the muscle. It [Pocket Protector] allows them to have a condition where they have [um] a relative insurance policy on the future. . .” (9:42 – 10:10)

Press Room Webpage3

• “While The Pocket Protector (as of 2003) is considered a relatively new device, the material has actually been used by Dr. Berman in dozens of womens breasts dating back to 1986 without any adverse reactions. The first prototype Pocket Protector, placed in April 1995, still remains completely functional. The e-PTFE materials in human use have been subjected to hundreds of clinical and laboratory research evaluations . . .” (Health News Digest Article)

• “The material used to produce the Pocket Protector has been used in other medical products and devices for years and is safe and very compatible with the body. By lining the breast tissue there is less risk of scar formation and the pocket stays open, reducing the risk of capsular contracture . . .” (Health News Digest Article)

• “The pocket protector allows tissue to grow onto it instead, with no scarring. The breast implant, placed inside the pocket, is free-flowing for a more natural appearance. What's more, Berman said the device makes implants safer.” (TheBakersfieldChannel.com Article)

• “The Gore-Tex material used for the pocket protector has been approved by the Federal Drug Administration and used in various procedures. Berman is waiting for FDA approval on the use of the pocket protector as a breast implant device. Right now, Berman is the only doctor in the country using the device.” (TheBakersfieldChannel.com Article)

• “Mark Berman, M.D., a cosmetic surgeon from California has developed a device that may reduce some of the potential complications of implant surgery. He has called his invention the ‘Pocket Protector.’ The Pocket Protector is a liner for the breast cavity.” (Medstar Television, Inc.)

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 III device.4 Because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 351(B), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g), the Pocket Protector is therefore adulterated under section 501(f)(1)(B). The Pocket Protector is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).5 We acknowledge that your firm submitted an application for an IDE for the Pocket Protector under section 520(g) of the Act, 21 U.S.C. § 360j(g). The Agency disapproved your application on July 28, 2017 due to numerous deficiencies, including (b)(4).

We received a response from you dated July 14, 2018, in which you reply to our investigators’ observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm, and assert that the Pocket Protector qualifies for the custom device exemption contained in section 520(b) of the Act, 21 U.S.C. § 360j(b). This exemption allows 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 under section 514 and 515 of the Act, 21 U.S.C. §§ 360d, 360e, is impractical.6 FDA disagrees with your assertion that the Pocket Protector qualifies for the custom device exemption. Section 520(b) of the Act requires, among other things, that the custom device exemption will apply only if all of the following limitations are satisfied: (1) the device is for the purpose of treating a “sufficiently rare condition, such that conducting clinical investigations on such device would be impractical;” (2) the production of the device must be “limited to no more than five units per year of a particular device type”; and (3) the manufacturer submits an annual report to FDA on the custom devices it supplied. Based upon the observations made during our inspection, and the statements in your July 14, 2018 response to those observations, the Pocket Protector does not qualify for the custom device exemption. For example, you failed to submit annual reports to FDA for devices you supplied (including the devices you admitted supplying to other physicians), and, in certain years, produced more than five units of the Pocket Protector. Additionally, you failed to comply with other statutory and regulatory requirements that apply to custom devices. For example, custom devices are not exempt from requirements of the Quality System Regulation, including Design Controls (21 CFR Part 820); Medical Device Reporting (21 CFR Part 803); Labeling (21 CFR Part 801); Corrections and Removals (21 CFR Part 806); and Registration and Listing (21 CFR Part 807).

Our inspection also revealed that the Pocket Protector devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:

1.  Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30. For example, your firm has not established design control procedures. In addition, your firm has not performed required design control activities for the Pocket Protector device, such as development of design inputs and design outputs; performance of design reviews; design verification; design validation, including risk analysis; design transfer; design change controls; and establishment of a design history file.

2.  Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm received (b)(4) lots of ePTFE sheets (b)(4) from supplier, (b)(4); however, no records were maintained to demonstrate that this supplier was evaluated or that received materials are acceptable for their intended use.

3.  Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). For example:

i. No Clean Rooms or otherwise qualified production environment was observed during the inspection.

ii. Your firm utilizes a (b)(4) (located in the “Sterile Room”) for the sterilization of instruments used during surgical procedures. The (b)(4) is also used to hold finished and packaged Pocket Protector devices, and the reusable syringes that hold the folded Pocket Protector Devices. The inspection observed that no records of equipment calibration or verification are maintained.

iii. Your firm utilizes (b)(4) cycle which are intended to ensure that the devices are exposed to the conditions of sterilization. Per your firm’s “(b)(4)” procedure, (b)(4). For example:

- The “(b)(4)” procedure does not require documentation of the inspection step.
- No records were maintained to demonstrate that the Steam Indicator strips and packages of (b)(4) Pocket Protectors sterilized between January 2014 and July 2018 (per the (b)(4) Log Sheets) were inspected.
- The (b)(4) Log Sheets do not identify the devices sterilized and no other records are maintained to demonstrate that each device is sterilized. For example, no records were provided to demonstrate that the devices implanted in (b)(4) patients (between 2014 and 2018) were sterilized.

4.  Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, that the process is validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example:

i. Your firm utilizes a (b)(4) for the sterilization of the Pocket Protector device. However, the sterilization process has not been validated.

ii. Your firm packages the finished Pocket Protector devices in (b)(4) Sterilization Pouches. However, the packaging process has not been validated.

iii. Manufacture of the Pocket Protector device includes an (b)(4) bonding process. However, the bonding process has not been validated.

5.  Failure to establish procedures for acceptance activities, as required by 21 CFR 820.80(a). For example: 

i. No acceptance records were maintained for two lots of polytetrafluoroethylene sheets (Lot#s (b)(4) and (b)(4)) received and used in the manufacture of Pocket Protectors that were implanted in two patients.

ii. No acceptance records were maintained for (b)(4) Pocket Protector devices manufactured and implanted in patients between 2014 and 2018.

6.  Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example: No protocols exist at your clinic/facility to address any non-conforming products or products deviating from the required product parameters.

7.  Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example: Your firm has not established procedures for corrective and preventive action (CAPA) or performed associated CAPA activities.

8.  Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example: your firm has not established complaint handling procedures or performed the associated complaint handling activities.

9.  Failure establish and maintain procedures to ensure that Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR), as required by
21 CFR 820.184. For example, your firm has not established procedures for DHRs or maintained any DHRs.

10.  Failure to maintain a device master record, as required by 21 CFR 820.181. For example, your firm has not maintained a device master record for the Protector device.

11.  Failure 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, as required by 21 CFR 820.150(a). For example, your firm has not established procedures for control of storage.

12.  Failure to establish procedures for management review, as required by 21 CFR 820.20. For example, your firm has not established procedures for the evaluation of the suitability and effectiveness of the quality system by executive management. Furthermore, no records were maintained to demonstrate that management reviews have been performed.

13.  Failure to establish procedures for quality audits, as required by 21 CFR 820.22. For example, your firm has not established any procedures for internal quality audits and has not conducted any quality audits.

14.  Failure to establish procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, your firm has no defined training procedures or requirements and no training records have been maintained.

Finally, our inspection revealed that your firm’s Pocket Protector devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), because your firm has failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations observed include, but are not limited to, your failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm has not established procedures for the timely and effective identification, communication, and evaluation of reportable events; the timely transmission of medical device reports to the FDA; or for compliance with the applicable documentation and record keeping requirements.

We have reviewed your July 14, 2018 response to our investigators’ observations and conclude that it is not adequate. The response acknowledges that no Quality System procedures have been established for the Pocket Protector Device, and states that your firm was not aware of the MDR requirements applicable to the device. Although the response also states that Quality System procedures will be established once IDE approval is obtained, and acknowledges awareness of the applicable reporting requirements, you have provided no evidence to demonstrate that corrective actions are being undertaken to address the violations noted on the Form FDA 483.

Your firm should immediately cease distribution of the Pocket Protector and take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

Your firm’s response to this letter should be sent to: oradevices3firmresponse@fda.hhs.gov Please refer to (CMS case # 562321) when replying. If you have any questions about the contents of this letter, please contact: Dr. Raymond W. Brullo, Compliance Officer at (949) 608-2918 or via e-mail raymond.brullo@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.

Sincerely,
/S/

Shari J. Shambaugh
Program Division Director
Office of Medical Device and Radiological Health
Operations Division 3/West 

___________________________________ 

1 www.markbermandmd.com/breast-augmentation/
2 The video is embedded in www.markbermandmd.com/breast-augmentation/.
3 www.markbermanmd.com/news/
4 The kind of information that your firm needs to submit in order to obtain approval for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
5 For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency as defined by 21 CFR 807.81(b).
6 See generally FDA’s guidance for industry Custom Device Exemption (issued Jan. 14, 2014), available at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm415799.pdf.