As an increasing number of men undergo hair restoration—more than 87,000 such surgical procedures were performed in the United States in 2005—the industry is seeking less invasive techniques to potentially appeal to a broader range of candidates.

Follicular unit extraction (FUE) is the most promising technique available for decreasing the level of trauma and pain for patients. However, a majority of physicians—particularly newcomers—are reluctant to use FUE due to its inherent difficulties.

This article discusses new instrumentation and methodology designed to improve FUE and provide value to both the patient and the physician.

Figure 1. The subcutaneous course of the follicles does not follow the angle of hair emergence (a). Sharp dissection with the punch results in transection of the follicular unit (b and c). The effect of follicle curvature results in a high proportion of transected follicles (d).

With this new method of graft harvesting, patients experience a reduction in follicle transection, a possible increase in donor capacity, less postoperative pain, faster healing, and barely detectable scarring.

For the 35 million Americans with male pattern baldness, the opportunity to improve the well-being of thousands of patients is considerable. For the physician, new instrumentation and methodology means a decrease in follicle transection, an enhanced ability for more exact planning, a decreased reliance on staff, an increased ability to obtain grafts from African American and gray-haired patients, and the potential to decrease overhead and reduce the need for technical equipment.

FUE Background

The basic process of hair transplantation is the removal of hair from the fringe area (sides and back), or “donor” area, and moving it to the bald, or “recipient” area.

Historically, 4-mm plugs were used as the donor “plug”; this was followed by mini-grafts (smaller plugs), and finally by follicular-unit grafts (FUGs). FUGs are naturally occurring aggregates of one to five hair follicles, closely spaced and distributed randomly over the surface of the scalp.

Traditionally, a strip of scalp skin containing hair follicles is removed from the donor area by dissection with a scalpel. Some follicles are invariably transected (cut or damaged) during this process. In addition to some follicular damage, the removal of a “donor strip” always results in a linear scar, which may be visible if the patient’s hair is cut short.

In addition to the scar, the patient experiences some moderate pain for several days and a sensation of tightness for 6 to 8 weeks following the procedure. Multiple procedures will result in multiple scars and thinning of the hair above and below the scar.

Figure 2. Illustration of the SAFE System. The curved follicle in situ (a) and the insertion of the sharp “scoring” punch to a limited depth of approximately 1.3 mm (b). Insertion of the dull “dissecting” punch to the distal end of the follicles (c) and the subsequent removal of the intact follicle with forceps (d and e).

If the surgeon miscalculates the pliability or laxity of the scalp and removes a strip that is too wide, this procedure has the potential to create a wide, unsightly scar because of the tension required to close the surgical wound. Sometimes, the resulting scar can be difficult to hide or disguise, causing a significant aesthetic deformity.

FUGs are then dissected from the strip of donor scalp by several technicians using operating microscopes. The FUGs are then sorted into groups based upon the number of hairs contained in each group. The best teams will have a 2% to 8% transection rate.

The dissection of grafts from the scalps of African Americans and those with a high percentage of gray or white hairs is particularly problematic.

The African American’s follicles have a high degree of curl or curve, making dissection difficult and prone to high transection rates. The follicles of white or gray hair are all but invisible, even under the microscope, which also makes them prone to a high rate of transection. Often, the best cutters can produce approximately 250 to 300 grafts per hour. An average cutter produces closer to 200 grafts per hour.

After the FOX

Figure 3. The 1-mm surgical punch for performing FUE using the SAFE System. The blunt dissecting punch is seen on the left end of the punch. The right side is a standard sharp dermal biopsy punch.

Recently, William R. Rassman, MD, and Robert M. Bernstein, MD, presented a technique for FUE called the FOX technique, whereby follicular units were “extracted” from the donor area without the need to create a linear incision with a scalpel.

This feat was accomplished using a sharp 1-mm punch to make an incision into the epidermis and dermis, followed by the removal of the follicular unit from the surrounding skin using forceps.

Their findings suggested that some follicles were easily removed; others had a significant tendency to shear in the process. According to their research, a “good” candidate experienced less than 20% shearing. Around 60% of the patients tested were considered “candidates” based on the shearing test.

Before & After

Figure 4. The donor area following SAFE System follicular-unit extraction at 1 day (a) and 14 days (b).

As described by Rassman and Bernstein, the procedure is technically difficult. For example, the punch depth is difficult to control. If it penetrates too deeply or at an incorrect angle, there is a good chance of transecting the follicular unit with the sharp end of the punch.

This method has not been widely adopted due to the problems of transection, the difficulty in removing the grafts, the time required to produce grafts, and the low percentage of potential candidates.

The SAFE System

To address the numerous problems and reservations about the FOX technique, the surgically advanced follicular extraction (SAFE) System was devised in order to diminish or eliminate the shortcomings of the existing instrumentation and surgical techniques.

Benefits of the SAFE System

For the patient:

  • reduced follicle transection; more hair available to transplant;
  • increased donor capacity as surgeons are no longer limited by scalp laxity;
  • significant decrease in postoperative pain;
  • faster healing;
  • minimal scarring; and
  • African American and gray-haired patients will benefit significantly from less follicle damage.

For the physician:

  • decreased follicle transection;
  • more exact planning for the number of grafts required;
  • ability to select certain FUGs (such as more four-hair FUGs than two-hair FUGs to create density, or more one-hair FUGs for the visible hairline);
  • decreased reliance on staff (FUGs can be obtained by the physician alone or via qualified staff with limited training);
  • the ability to obtain grafts from African American and gray-haired patients with confidence and minimal transection;
  • the possibility of decreasing overhead and need for technical equipment (ie, microscopes for graft dissection);
  • the possibility of decreasing the price per graft and enlarging the potential market;
  • advanced technology and instrumentation results in superior patient outcomes, which provide the physician with marketing advantages; and
  • opens the procedure to physicians who have hair-restoration experience but lack trained staff.

The SAFE System was developed 5 years ago and first presented at the 12th Annual Scientific Meeting of the International Society of Hair Restoration Surgery in Vancouver, British Columbia, in August 2004.

When testing patients with demanding hair types, African Americans, and those with gray hair, follicle-transection rates were less than the microscopic dissection technique of graft production. Extrapolation of timing trials using the SAFE System revealed the ability to extract more than 300 grafts per hour. This rate of graft production may convey the ability to transplant up to 2,000 grafts per day.

The SAFE System is a sequential method of follicular extraction. The first step uses a mass-produced, sharp 1-mm or .75-mm (inside diameter) skin biopsy punch to “score,” or incise, the skin to a depth of approximately .3 mm to .5 mm. The punch is then removed from the skin surface.

Incising to this limited depth drastically reduces the risk of follicle transection because of the geometry of the follicle and the limited depth of the incision.

Following this initial step, a blunt 1-mm or .75-mm punch called the Scribe dissecting punch (available from Ellis Instruments, Madison, NJ) is placed into the circular incision created by the scoring punch. It is rotated slightly and pushed into the skin to its maximal depth.

Typically, a “popping” sensation is felt as the leading edge of the punch goes past the more dense tissues. The dissecting punch is then removed, and the graft is grasped with forceps and removed from the skin. The blunt aspect of the dissecting punch reduces transection of follicles to a range of less than 2% to 6%, which is accomplished by guiding the group of follicles into the lumen of the punch without exposure to sharp surfaces.

Currently, testing is under way on a serrated dissecting tip that will allow the direct insertion of the punch into the skin without the need for a “scoring” incision—thus reducing the amount of time required to harvest the follicular units. In addition, testing has begun on a powered device that can dissect and extract grafts.

The Patient’s Challenge

The FUE technique can offer all the advantages of traditional follicular unit grafting, mainly aesthetic results that are totally undetectable as a transplant, plus many more.

Patients are constantly challenging the medical profession to find innovative ways to provide high levels of care while minimizing trauma and speeding the recovery process.

The proven way to accomplish this is to minimize trauma to the body’s systems. In the realm of hair-restoration surgery, this is accomplished by reducing the volume of donor tissue that is removed.

FUE has proven that by decreasing the amount of tissue removed—up to 30% to 60%, depending on the punch size used—the patient will experience a significant decrease in pain and in the time required for recovery.

The possible advent of a powered FUE device will further enhance efficiency, which will lower the patient’s costs and increase the physician’s profit margin.

Before & After

Figure 5. Frontal and upper crown reconstruction using the SAFE System. The frontal area (a) used approximately 400 follicular units while the upper crown (b) had approximately 900 grafts. The “after” photos are 10 months postsurgery.

James A. Harris, MD, FACS, is the medical director of the Hair Sciences Center of Colorado, Greenwood Village, Colo. He is a diplomate of the American Board of Otolaryngology, a fellow of the American College of Surgeons, a member of the American Academy of Otolaryngology, and a member of the International Society of Hair Restoration Surgery. He is a clinical instructor of hair transplantation at the University of Colorado Health Sciences Center in Denver. He can be reached at (303) 694-9381.