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Archive for the ‘medical devices’ Category

Plastic Surgery Product Review – Refine Soft Tissue Suspension System

Wednesday, September 11th, 2013

 

The ideal youthful breast has fullness in the upper pole, does not sag, and has a slightly pendulous lower pole. The slope of the upper pole should be slightly convex, straight, or slightly concave. With time, and gravity, many women lose that nice fullness in the upper pole, aging the breast and making it less attractive. In order to combat this problem, plastic surgeons have tried many different techniques in order to reestablish or make upper pole fullness.

The Refine internal suspension system is a new device that has been developed an use with this problem in mind. The Refine system is a soft and flexible suture-mesh-anchor system that provides the soft tissue with internal support. It is made from medical grade polyester. It has been FDA approved and is indicated for the reinforcement of soft tissue.  The Refine system is placed percutaneously using specialized needles and is a two part system. The first part is the anchor utilizing a small piece of flexible mesh which is placed just deep to the pectoralis fascia. The second part using anchors which engage into the soft tissue, lifting the tissue up.  The two parts are then secured together, burying the knots deep in the soft tissue of the breast.

The most common use of the Refine system is for breast lifts in order to maintain upper pole fullness. When performing a breast lift or a breast reduction, with time, the breast tissue settlesor bottoms out and loses that upper pole fullness that many women want. By using the Refine system, plastic surgeons can permanently lift the breast tissue, maintaining that fullness for a more youthful look. The Refine system is not palpable and cannot be seen on mammography.

Plastic surgical experiences with the Refine suspension system in the breast have been promising and results have been maintained. Overall complications from this device seem to very low and patients report minimal discomfort after placement. This is an exciting new tool for plastic surgeons that is optimally used in conjunction with other breast procedures such as reductions, lifts and with fat injection breast augmentations.

Dr. Barry Eppley

Dr. Jane Namkung

Indianapolis, Indiana

Plastic Surgery Product Review: GalaFLEX Mesh

Saturday, April 27th, 2013

 

Numerous plastic surgery procedures involve tucks and lifts to achieve their effects. While many intraoperative techniques are done to tighten and support lifted tissues, no such result is permanent. Tissue relaxation and stretching and the effects of gravity work almost from the first day after surgery to undue some of the achieved result.

While tissues may be tightened and reinforced, their inherent lack of thickness or structural weakness may not provide optimal support. This is where the role of an implantable mesh material has always been appealing. But the use of traditional polymer meshes when placed right under the skin have a long history of potential complications, most notably palpability, thinning of the overlying tissues and even extrusions.

An appealing reinforcing mesh would be one composed of a resorbable material. This is the role that allogeneic meshes have filled, such as Alloderm and Strattice, which provide a dense collagen material which is fabricated from donor tissues. While very effective, its costs are considerable particularly in bigger pieces.

GalaFLEX mesh composed of a resorbable material that has FDA approval to reinforce soft tissue where weaknesses exist or for use in procedures involving soft tissue repair or other fascial defects that require the addition of a material support to obtain the desired result. Uses in aesthetic plastic surgery could include facelifts, necklifts, browlifts, breast lifts and breast reductions.

GalaFLEX is a flat knitted elastic mesh composed of poly-4-hydroxybutyrate (P4HB) which is from a class of materials known as poly-4-hydroxybutyrate that are produced naturally by bacteria in a recombinant fermentation process. It is a resorbable material that is broken down by water absorption and eliminated from the body as carbon dioxide and water in 12 to 18 months after implantation.

GalaFLEX mesh is of particular interest to plastic surgeons in breast surgery as an inferior pole sling support. Bottoming out of the breasts after breast lifts and reductions is a common aesthetic problem after these surgeries.

Dr. Barry Eppley

Product Review – Insorb Absorbable Skin Stapler

Tuesday, April 23rd, 2013

 

Closing incisions is an inherent part of every surgery and a well healed and good looking scar is a desireable goal. But for plastic surgeons the appearance of the incisional closure and the resultant scar takes on even greater significance. For operations that are done for cosmetic change only, a good looking scar is an essential part of how the result will be perceived.

To get the best scar outcomes from incisional closures, plastic surgeons pay great attention to the relief of underlying wound tension and the meticulous approximation of the skin. For these reasons either very small sutures are used in many facial areas and a subcuticular (under the skin) technique is used for large body areas under the skin. While most only see what is placed at the skin level, what is buried underneath the skin in the dermis is of equal importance. This requires the placement of many intradermal buried sutures, usually of a resorbable material.

This intradermal suture placement is essential but tedious and certainly adds to intraoperative time. To simplify this level of suturing, an absorbable stapling device (Insorb) was introduced several years ago. This device places small staples made of resorbable polymers (polylactide-polyglycolide) that have a long history of use as resorbable sutures and plates and screws. The minute staples are placed in a horizontal orientation by a patented stapling device that can deploy up to 30 staples. The staples are placed right under the skin in the thick dermis to approximate the skin. They will resorb completely by a natural hydrolysis process over 6 to 9 months.

The Insorb device is intended to replace the need for external skin staples and/or the need for subcuticular skin sutures. For some body plastic surgery procedures, such as tummy tucks and breast reductions, this device can have a useful role. While not eliminating the need for a subcuticular skin closure, it can alleviate the need for intradermal suturing. In the face, however, the skin is too thin to permit even this very small size of the staple to be useful.

Dr. Barry Eppley

Plastic Surgery Product Review: Keller Funnel for Silicone Breast Augmentation

Friday, April 19th, 2013

 

Despite the different types and sizes of breast implants and the different incisions used to place them, all these breast augmentation issues share one factor…implant insertion. With a prefilled and fully inflated silicone breast implant, there is increased difficulty in getting the implant into place because of the mismatch between the diameter of the implant and the length of the incision. Historically silicone gel implant insertion has been done by the manual method. The plastic surgeon must physically handle the implant and push it through the incision into the created submuscular or subglandular pocket. The actual handling of the implant by the surgeon adds another source of potential infection as well as stresses the shell of the implant as it usually needs to be ‘forced’ through the incision.

A novel breast implant insertion device is available that overcomes all of the concerns about manually handling and manipulating the implant. Known as the Keller Funnel, it is a cone-shaped device with an internal silicone lining. This allows the breast implant to be opened and placed directly into the funnel right out of the sterile box. Then by twisting the backside or larger end of the funnel, the silicone implant can be squeezed out of the end of the smaller end of the implant and through the incision right into the created breast pocket. The implant shell is less stressed as the forces of distortion or pressure on it are more evenly distributed throughout the entire implant shell. The silicone lining allows the implant to be lubricated so it can flow smoothly out of the funnel when under manual compression.

The Keller funnel is a significant advance for silicone breast augmentation. While it does add a very small cost to the procedure, it reduces the risk of infection and potentially even adds to the longevity of the implant’s durability.

Dr. Barry Eppley

Allay Menstrual Patch – Clinical Trial Results

Saturday, June 6th, 2009

Objectives: To test the safety and effectiveness of a wearable Pulsed ElectroMagnetic Field device (PEMF), called the Allay Period Relief Patch, for the symptomatic relief of the pain associated with dysmenorrhea.

Design: A prospective randomized double-blinded and positive controlled clinical trial was conducted in two different cities (Indianapolis and San Francisco) of randomly selected women between the ages of 18 to 35 who experience moderate to severe menstrual pain.  Allay Patches were asked to be worn at the onset of one’s menstrual cycle and worn for five consecutive days. Prior to wearing the patch each women recorded her level of pain during a traditional menstrual cycle.  The outcome measure while wear the patch was then was compared to that of their traditional cycle pain.

Participants: Ninety-one (91) women were enrolled with moderately severe dysmenorrhea and were randomly assigned an active or control Allay Patch.

Results:  Of the ninety-one (91) study enrollees, forty-four (44) were from San Francisco and forty-seven (47) from Indianapolis. Forty-eight (48) patients had active patches while the remaining forty-three (43) were placebos. The average age of study patients was 26.2 years.

Of the active patch group, thirty-seven (37), which represents 77.1% of the group, reported either complete elimination or reduction in their typical menstrual pain symptoms. Four (4) patients in the active patch group reported no pain at all (10.8%) while the average amount of pain reduction in the remainder was 55%.  (range 10 – 95%)  48.6% (18) showed least a 50% pain reduction.

In the active responder control group (placebo), no patients (6) reported complete elimination of pain while the reduction in pain averaged 20%. The differences in positive response to either the active or control patch was of statistical significance. (p < 0.05)

Conclusions: The Allay Patch is an effective and safe non-drug method for use in the treatment of primary dysmenorrhea. It can be used as a primary treatment method for those women with moderate dysmenorrhea who do not prefer to take medication. In more severe cases of dysmenorrhea, it can be an adjuvant treatment to reduce the amount of duration or other oral medications.

Dr. Barry Eppley

Indianapolis, Indiana

Endoscopic Browlift Surgery with Lactosorb Screw Fixation

Sunday, February 8th, 2009

Sagging of the brows with age has historically been improved through browlift surgery. Traditionally browlift surgery was done through long incision back in the scalp and the lift of the brows and forehead obtained was gotten by removing scalp skin. Endoscopic browlift techniques have become very popular in the past decade as they can accomplish browlifting but without the need for long scalp scars.

Like laparoscopic abdominal surgery, endoscopic browlifts use a few small incisions in the scalp and rely on releasing the brow and forehead from the bone through the assistance of small cameras and instruments. The actual lifting of the brows is really accomplished by shifting the forehead and scalp backwards, rather than cutting out scalp as in open browlift surgery. An essential part of this ‘scalp shift’ is that it must be held up in place until the tissues heal back down to the bone. Some form of soft tissue suspension or fixation is needed to make endoscopic browlift surgery work.

While there are many touted methods of endoscopic browlift fixation, and they all appear to work reasonably well, I prefer to use a resorbable screw placed into the skull from the small scalp incisions. Onto these screws, the forehead tissue can be sutures up to the screws holding it in place after surgery. Studies have shown that the tissues must be held in place for at least two weeks and preferably up to one month after surgery. These resorbable screws hold their strength out to 6 to 8 weeks, well beyond what is needed to accomplish forehead healing.

I have used these resorbable endobrow screws (Lactosorb) for the past 12 years and find their use quick and secure. In the old days, I used to have to cut threads into the bone to place the screw, but this has been replaced by a push screw several years ago. Patients may feel the screw
heads for a few months after surgery if they push hard enough, but that feeling goes completely away between 4 and 6 months after surgery. While metal screws will work just as well, patients find comfort in knowing that no permanent devices are left behind on their skull.

Dr. Barry Eppley

Indianapolis, Indiana

Allay Patch (ActiPatch) for Menstrual Pain – Pilot Study

Wednesday, January 28th, 2009

Cramping and pain are common problems for many women during their menstrual period. Sharp pains in the lower abdomen begin at the start of menstruation and may continue for 3 to 4 days. The pain can range from mild to severe and often interferes with many normal activities. While the majority of women who have menstrual periods have some discomfort, 10% or more are temporarily disabled by the discomfort.

Many different treatment strategies have been tried for menstrual pain but the most commonly used are non-steroidal anti-inflammatory drugs. (NSAIDS) Despite drug therapy, universal relief is not obtained and some patients experience gastric upset and other minor problems with NSAID use. The search for a cost effective, non-drug, anti-inflammatory approach to menstrual pain continues.

ActiPatch is a topically applied battery-operated device that elicits pulsed electromagnetic fields that has proven to be capable of modulating inflammation and edema in local tissues. It is easily applied and removed and is inexpensive. I have used it in my plastic surgery and spa practices over the past two years and have found it effective for postoperative relief of pain and swelling after breast augmentation, liposuction, and certain types of facial surgeries. I have also personally used it as well as family members for a variety of musculoskeletal and joint pain issues and have found it helpful. I recommend it to all of my patients for a variety of inflammatory and pain issues. This experience prompted me to wonder if this technology would be effective for the common female problem of menstrual pain. Having a medical and spa practice that is predominantly women, I had a fertile environment to test its potential benefits.

Beginning in August 2008, I solicited and identified twenty-three (23) female patients (ages 19 to 37) with problematic menstrual issues that were willing to test the patches. They were provided with a questionnaire that allowed them to rate their menstrual pain on a 1 – 10 scale as well as a daily rating of their pain using this scale beginning on their first day of menstruation up to five days after. To serve as their own controls, they initially used these ratings on a regular menstrual cycle without ActiPatch treatment. Once their control data was obtained, they were provided with an ActiPatch to use which measured 6 x 10 cms. They were instructed where and how to apply it and to use it continuously for 5 days when the onset of their menstrual period was evident. They rated their pain over this time period using the same 1 – 10 pain scale as they used during their control period. The patients were asked not to take any oral medications during the study period.

The patient results obtained indicated that during the control period, the average composite pain rating was 7.8. (highest 10, lowest 4) From day one to five, the average composite daily pain ratings were 8.3, 7.9, 7.4, 6.5, and 5.7, respectively. During the ActiPatch treatment sessions, the average composite pain ratings was 5.4 (highest 8, lowest 2) for the same set of patients. Their average composite daily pain ratings were 5.7, 4.8, 4.3, 3.4, and 2.1 for days one through five. The correlates to an overall pain reduction of 30% and on a daily basis of 31%, 39%, 42%, 48%, and 73% respectively. This indicates as the days of menstruation went on, the amount of pain reduction continued to improve either from cumulative effects from ActiPatch therapy, a reduction in actual menstrual pain as flow decreases, or a combination of both.

This initial pilot study provides evidence that ActiPatch does appear to contribute to pain relief from menstruation. The size of the patch is able to produce a field that can penetrate deep enough into the tissues to create a positive effect. The data reported here represent overall trends and further intrapatient statistical analysis needs to be done to determine individual improvement.

These menstrual findings are not surprising to me as they are consistent with what I have observed in recovery after numerous plastic surgery procedures. ActiPatch, now known as ALLAY for application for menstrual pain, appears to have a useful role for women who suffer from painful periods. Its ease of use, low cost, and ability to be combined with helpful aids, such as NSAID medications and heating pads make it an ideal therapeutic option for many women.

 Dr. Barry Eppley

Indianapolis, Indiana

ActiPatch for Breast Augmentation Recovery

Wednesday, April 9th, 2008

ActiPatch is a non-drug, anti-inflammatory device that has been used for multiple medical conditions from facial surgery recovery to plantar fasciitis. It helps reduce swelling and inflammation through the use of pulsed electromagnetic fields contained in either a patch design or a loop configurations. The patch or loop devices contain a tiny circuit which is operated by a small low-voltage battery. Beneath the geometry of the circuit, a penetrating electromagnetic field or zone is created which penetrates into the tissues under the skin. The frequency of the generated signal works by decreasing intercellular fluid and inflammation in the injured site. As a result, the amount of swelling and associated pain around a surgery site is reduced and recovery is accelerated.

I first starting using ActiPatch for my own back and shoulder pains from years of long hours of surgery. It worked as well as any non-steroidal anti-inflammatory medication and I began to use it on my breast augmentation patients. By positioning a crescent patch over the upper medial pole of the breast (where the raised pectoralis major muscle exists) and another patch over the lateral pole of the breast (4 patches per patient), I have been equally impressed with the results. My past 25 breast augmentation patients have used it with good success. It is now part of my routinue postop breast augmentation protocol and I have each patient wear them around the clock for the first 48 hours after surgery. In most cases, patients are off pain medications within 24 hours.

While I aggressively place them on an arm exercise program after surgery,which makes a big contribution to their recovery as well, the use of the ActiPatch is a simple and easy adjunct to this recovery protocol. Breast augmentation patients are extremely appreciative of any efforts made to decrease any potential pain, which is their biggest fear about breast augmentation surgery. Based on my experience with it in the breast implant patient, I can see no reason why it would not be of benefit for all kinds of breast surgery as well.

Dr Barry Eppley

Indianapolis, Indiana

ActiPatch – A Helpful Aid For Plastic Surgery Recovery

Monday, November 5th, 2007

Advanced Bio-Electric Healing Technology

What can I do, as a plastic surgeon, to help my patients recover faster? What can I do to help their swelling, bruising, and pain be less? We use all of the traditional therapies of cold compresses, arnica tablets and gel, elevation of the surgical area, and pain medications. But I have recently added a new option, offering advanced bio-electric therapy (ActiPatch) to help my patients heal better after surgery.

ActiPatch delivers the same pulsed electromagnetic therapy, used by physicians, therapists, and athletic trainers worldwide to reduce pain and swelling and accelerate healing. The traditional clinical treatments of bio-electrics is expensive and inconvenient for most patients. Now, through microchip technology, this home-based therapy is available in a convenient, easy to use, low-cost patch. Applied right after surgery, and used for the first week after surgery, ActiPatch works by driving out the swelling and negative by-products from the damaged tissues. With less swelling, a decrease in pain occurs.

ActiPatch is a wearable technology, is flexible, light weight, and easy to apply and use. Once activated, ActiPatch begins pulsing a continuous low level current to energize damaged cells in the surgical region, helping remove the effects of surgery so you can feel better and look better faster!

ActiPatch has been shown to be effective in reducing pain in breast augmentation, abdominoplasty, blepharoplasty (eyelid), nose and facelift surgeries. I consider it a very useful aid in my Indianapolis plastic surgery practice.

Dr Barry Eppley

Indianapolis, Indiana


Dr. Barry EppleyDr. Barry Eppley

Dr. Barry Eppley is an extensively trained plastic and cosmetic surgeon with more than 20 years of surgical experience. He is both a licensed physician and dentist as well as double board-certified in both Plastic and Reconstructive Surgery and Oral and Maxillofacial Surgery. This training allows him to perform the most complex surgical procedures from cosmetic changes to the face and body to craniofacial surgery. Dr. Eppley has made extensive contributions to plastic surgery starting with the development of several advanced surgical techniques. He is a revered author, lecturer and educator in the field of plastic and cosmetic surgery.

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