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The Pocket Protector™ was
developed as a synthetic (expanded-polytetrafluoroethylene, or e-PTFE) bladder
used to line the breast pocket, integrating with the body and maintaining
patency of the pocket. A smooth surfaced gel (or saline) implant provides
volume enhancement by insertion within the Pocket Protector™. The net result
yields a soft, ripple-free (or near ripple-free) breast. Additionally, gel
implants inside the Pocket Protector™ are potentially shielded from the body
should they rupture. Implants are easily exchangeable if necessary without need
for capsulectomy or capsulotomy. It may also represent an implant device
appropriate to treat breasts refractory to traditionally attempted
augmentations, such as subcutaneous mastectomy. While the first case performed
in April 1995 has remained successful, most of the experience has been gathered
over the last year. This preliminary paper presents the experience with the
last 38 cases.
Breast augmentation surgery has generally been accomplished with implants designed to approximate additional breast volume. With few exceptions, such as the polyurethane coating on the former Meme implant, most shells have been made out of silicone rubber.1-3 The implant has generally been filled with saline or silicone gel, though a few other materials (e.g., soy oil, peanut oil, “bio-oncotic” gels, hydrogel) have been tested. In recent years, studies on patients with implants has focused on the content with regard to the implant’s effect on the body.4-5 In spite of the many problems associated with silicone gel implants - its potential for rupture, granuloma formation, extra-capsular spread, capsular calcification, peri-prosthetic infections - contemporary studies have not implicated it as a causative agent for immune conditions on its own.6-22 In spite of the tremendous controversy over silicone gel and the psychological and physical symptoms attributed to it, it appears that many of the real problems related to breast implants have to deal with the external shell rather than its contents.23 While there are fewer capsular contractures reported with saline implants and general satisfaction, there have been increased problems of tissue rippling, as well as a significant number of deflations.24-25 Also, saline implants, probably by virtue of the tendency to over-inflate, are generally more palpable compared to normal breast tissue or silicone gel augmented breasts. While some breasts do well with saline implants, above or below the pectoralis muscle, there is a subset of breasts that have unique problems. These breasts are generally fairly thin and have a potential pocket space significantly larger than the desired volume for augmentation. In such a breast, a smooth implant might reduce rippling, but would have a higher risk for encapsulation. A textured implant, even a textured gel implant, above the muscle, and even as a partial subpectoral placement, would have a high risk of rippling. As such, the author suggests that this large subset of patients has two problems that are better treated by two implant devices - one to maintain pocket integrity and another to approximate natural breast tissue.
For years, advances in breast augmentation surgery have focused on the technique and/or the implant. Technique variations have largely dealt with the position of the incision, methods of dissection, position of the pocket, preparation of the pocket and handling of the implant. The implant design has largely focused on shape, content and surface, but has always involved a single prosthetic device.26-44
One of the problems with breast augmentation surgery deals with the fact that there are significantly different categories of breast types. In simple terms, breasts for augmentation can be classified as two primary types. Type A would be a breast that has a relatively small potential pocket space, such that the desired implant nearly fills the potential space. Type B breasts have a large potential pocket space, such that the desired volume of increase is substantially smaller than the potential space. A type A breast might commonly be seen on a young nulliparous patient, while a type B breast might be found on an older individual or a multiparous patient. Additionally, each type may present with either adequate tissue cover or thin tissue cover.
While type A patients generally do well with smooth or textured implants because the implant fills the pocket and therefore stents it open, type B patients are more problematic with the currently available implants. Textured saline or gel implants have been used fairly successfully to reduce capsule contracture.45 However, there appear to be a significant amount of rippling, particularly in thinner patients. Submuscular placement may reduce rippling, but in such patients total submuscular placement results in a “breast hanging off the muscle” appearance, and a partial submuscular placement, as generally recommended for such cases, only partly conceals rippling. Smooth silicone gel implants provide the softest, most natural result with minimal rippling, but they do little to keep the pocket open. Massage had been recommended, yet statistically, 40 - 50% of such augmentations resulted in capsule contracture. Double lumen implants with steroids and pocket lavage or injection with steroids has been used as well, though not always successfully and frequently with serious complications, such as tissue atrophy leading to dehiscence.
With this in mind, and having had experience with e-PTFE, it became apparent that it might be fortuitous to develop two implant devices to effect the desired results.46-47 Smooth silicone gel still remains the softest, most natural feeling breast tissue augmentation material. E-PTFE is considered one of the safest synthetic implant materials. Nonetheless, e-PTFE does not have the elastic properties of silicone rubber and would not serve well as a coating on the implant. However, e-PTFE could be designed into a bladder and serve as a liner for the potential breast pocket. By achieving tissue ingrowth into the material, the pocket is stabilized and thus remains patent. Microporous (20 - 100 micron porosity) e-PTFE does not elicit concentric scar tissue formation, but rather tissue ingrowth of blood vessels and connective tissue into its interstices. An optimal thickness should provide adequate ingrowth and tensile strength while being thin enough to avoid being palpable. As such, we’ve arrived at a material that is .35mm in thickness with a 40 micron porosity. The body rapidly grows into the material and within 3 months there is no evidence of foreign body reaction, and as such, no degradation with chemical or structural change of the material.
By virtue of these unique properties, it is expected that the Pocket Protector™ should provide the following benefits to augmentation mammoplasty: 1) prevent capsule contracture; 2) allow for placement of a smooth surfaced silicone gel implant, thus achieving optimal softness and natural feel; 3) prevent or minimize rippling; 4) provide a barrier against potential infection; 5) provide a barrier in case of possible gel rupture; 6) provide an internal brassiere to prevent sagging; 7) allow for easy exchange of implant if necessary (e.g. increase or decrease size); and 8) allow for improved results with traditionally difficult cases, such as subcutaneous mastectomy.
As of the submission of this paper, the Pocket Protector™ has been implanted in 38 patients. The patients represented a fairly broad base of cases - from primary augmentation to those who had multiple revisions. Data was collected for several aspects of the operation, following the patients for subsequent sequelae.
All patients were evaluated prior to surgery and laboratory evaluation or medical clearance was obtained as indicated. Patients were photographed and marked in a standing position prior to the operation. The mammoplasty procedure was performed via the areola or inframammary fold incision. Electrocautery was the primary tool for capsulectomy and dissection of the potential pocket, utilizing an extended electrode with a SAF-T-VAC™ device. All patients received the Pocket Protector™. The configuration of the material’s width and porosity evolved arriving at its current form by patient number 4. The very first patient received a pocket protector made from 1mm soft tissue patch material from W.L. Gore, sewn together by Surgiform, Inc. Subsequent trials were done using material manufactured by the C.R. Bard Peripheral Vascular Devices division. Patients number 2 and 3 had e-PTFE material that was slightly thinner (number 2) and slightly stiffer (number 3). The current composition of the e-PTFE at .35mm thick and 40 microns porosity was established by patient number 4. The material is fashioned as a flat posterior sheet 18 - 20 cm in length and 15-16 cm in width with the base slightly wider than the superior aspect. The anterior component is stretched in a dome shape and currently sewn to the posterior sheet at the Surgiform lab. The volume approximates 850cc as a medium size. A large size approximates 1200cc.
Currently, the Pocket Protector™ is loaded into the Pocket Protector Placer™ (P3™) and sterilized in order to facilitate placement of the device. The P3™ is a tube that houses the Pocket Protector™. Four Keith needles attached to the four peripheral points of the Pocket Protector™ by double strand nylon suture are correspondingly held in place on the outside of the P3™ device. The needles are passed through the superior, left, right and inferior points of the breast from inside the pocket, exiting externally where the needles are removed and the suture is secured around a soft foam rubber bolster.
It should be noted that the device has received FDA clearance for the material, and, indeed, the FDA recognizes that it can be used within the breast pocket. The FDA, while recognizing the safety of the material does not have enough information (yet) to allow the manufacturer to market its efficacy.
Patients opting to receive the Pocket Protector™ are provided with a video presentation as well as additional written material to aid in the informed consent. The first several patients were videotaped responding to the informed consent. I no longer do this.
Once the pocket protector is positioned, and the right, left and inferior aspects are secured, smooth silicone rubber surfaced prostheses - gel or saline - are inserted within the Pocket Protector™. By partially filling (150-200cc’s) the Pocket Protector™ with antibiotic fortified saline solution prior to implant insertion, the prosthesis inserts more easily. The superior aspect is secured on its bolster after placement of the implant to minimize the risk of tearing the material during retraction and implant placement.
The patients were
subsequently followed and data collection continued providing individual and
(also had capsulectomy)
Two patients, both of whom had flu symptoms, developed severe seromas bilaterally and ultimately had the e-PTFE material removed. The first also had the implants removed, however with the second patient, the implants were sterilized and left in the pocket with drains knowing that a capsule contracture was likely to occur, but at least a mound would remain while adequate time passed and revision could be done. All cultures were negative. All other patients tolerated the procedure well and ultimately had positive outcomes with soft, natural breasts.
Two patients experienced localized swelling one or two weeks after the procedure. In both cases, there was a report of a vigorous motion or activity followed by a noticeable pain and swelling. In the first case, the areolar incision was opened and a small lateral pocket of blood tinged serum was aspirated and a clot was removed exposing a small bleeder that was simply cauterized. The patient had an uneventful recovery and 10 months later was still soft and asymptomatic. The second patient was treated by aspiration through the areola incision with a 3mm liposuction cannula. 60cc’s of bloody fluid was removed without any further negative sequelae.
In spite of using smooth surfaced silicone gel implants, three patients with very thin skin exhibited some rippling. Still, all patients revealed soft, Baker class I breasts and, except for one patient displeased with some slight rippling, were uniformly happy with their results.
Two-thirds of the patients were between 40 and 60 years of age. Most patients had revision surgery for problems with their current implants. Five of the patients had primary surgery. The majority of implants were between 300 and 450 cc’s in volume. All of the Pocket Protectors™ were medium size, averaging 850cc’s in potential capacity.
The Pocket Protector™ was
used in a variety of cases, from primary augmentation to several cases that had
been treated with multiple procedures and various implants including the newer
textured implants - both saline or silicone gel filled. Capsules encountered
varied from very thin to thick and calcified. Previous implant status varied
from intact to ruptured and confined within the capsule or spreading into
adjacent tissues. Often silicone granulomas were resected outside the confines
of the capsule.
Several years ago, Bill Gore left the Dupont Corporation with an idea to make Teflon™ into a stretchable material. Eventually, he and his son succeeded and founded W.L. Gore and Associates. Their principal product, Gore-Tex®, or e-PTFE, has three general product categories - industrial, clothing and medical. After reviewing an article written by H. Bryan Neel in 1983, I contacted a representative at W.L. Gore’s Medical Division in Flagstaff, AZ.48 In September 1983, we met at their facility where they provided me a tour of the plant and we spent several hours discussing the material, its past and current uses, as well as potential ideas for future use, particularly in the area of plastic surgery, a field they had yet to enter.
Shortly, after returning to Los Angeles, I implanted Gore-Tex Soft Tissue Patch over a nasal dorsum and a week later, implanted silicone rubber cheek implants coated with the same material in another patient. In spite of some claims by others, these were the first documented uses of e-PTFE for plastic surgical uses.46 To date, I may still be one of the only doctors commonly using e-PTFE bonded to silicone rubber facial implants. The FDA approved the use of Gore’s e-PTFE for facial implant material in 1994.
Aware of the existing problems with the current mammary prostheses, I suggested that e-PTFE might be useful in resolving some of those problems. First, however, because I trained in Otolaryngology/Head and Neck Surgery, I sought additional training in breast surgery. In particular, I am indebted to William Roy Morgan, M.D. for the courses he organized on cosmetic breast surgery through the American Society of Cosmetic Breast Surgery. I attended additional breast courses made available through the American Academy of Cosmetic Surgery. Eventually, after adequately performing several breast augmentation procedures, I convinced McGhan Medical that e-PTFE could be a valuable tool for solving the “capsule contracture” problem plaguing the industry.
I implanted several custom designed smooth surface silicone gel implants partially coated with e-PTFE. While many of the prostheses did well (remained soft), a few developed capsule contractures. When I later had the duty to perform the capsulectomy and revision mammoplasty, I found that there was virtually no scar tissue over the e-PTFE area. However, the e-PTFE doesn’t stretch (like silicone rubber), therefore coating it onto the prosthesis defeats its purpose - essentially placing a “capsule” onto the prosthesis. At some point the “light went on” and I realized that while silicone gel implants had excellent tissue imitating characteristics, they could not be counted on to prevent capsular contracture. Of course, it can be argued that capsule contracture has been significantly diminished with the use of either textured surface implants or the current saline implants. Still, some patients seem to be refractory to any of these implants, or if they do well with a textured implant, it’s not infrequent that rippling may occur.
E-PTFE has a long record for safety as well as excellent tissue characteristics that allow for tissue ingrowth without scar tissue formation.49-57 By developing a bladder that could line the potential pocket space, it could potentially provide patency for the pocket while the silicone gel implant imitates natural breast tissue without concern over capsular contraction (FIG. 1). Indeed, results of testing to date validate this observation.
While the Pocket Protector™ was conceived as a device to prevent capsule contracture, particularly in type B breasts, it has (so far) proved useful in all types of augmentation mammoplasty, including revision cases refractory to other treatments and simple primary augmentations in type A or B patients (FIG. 2, 3). The particular design of the Pocket Protector™ uniquely allows for tissue ingrowth without capsule formation. This provides an integrated synthetic barrier that maintains pocket patency both by preventing concentric scar formation and preventing the newly created raw surfaces of the pocket from re-attaching to each other. Consequently, a more ideal implant can ultimately be placed within the breast pocket ultimately achieving optimally natural appearing and feeling results. Implants can be placed in the pre-pectoral plane avoiding the occasional unnatural results, distortion upon muscle contraction, or the trauma associated with elevating the muscle away from the chest wall (FIG. 4)
The combination of thinness and porosity provide for an exceptionally supple material without significantly compromising the tensile strength. This thus allows for placement of a smooth walled silicone gel (or saline) implant. Such implants are considerably less likely to cause significant rippling compared to textured surface implants. Nonetheless, the modern silicone gel implants have a shell that’s considerably thicker (though admittedly, less permeable) than those of the past. Ultimately, a thinner shell (maintaining its integrity and decreased permeability) would provide a more ideal implant with regard to palpability or rippling.
The first Pocket Protector™ prototype was tested in April 1995 on a patient with Type B breasts as a primary operation. 1mm Gore-Tex® Soft Tissue Patch material was sewn together as a bladder and implanted with a McGhan style 40 270cc smooth gel implant. The patient’s breasts continue to remain natural in appearance and soft to palpation (FIG. 5). After adequate time to follow-up this patient, we (Surgiform and I) applied for a patent. This was ultimately granted on November 14, 2000 (US Patent #6,146,418). Subsequently, recognizing that 1mm STP was much too thick to be useful, we spent considerable time developing the optimally structured material, eventually arriving at an e-PTFE .35mm thick and 40 microns in porosity. This provides a material of adequate tensile strength yet minimally palpable even under very thin skin or if folded upon itself. It also provides adequate porosity to allow for sufficient tissue adherence. These current pocket protector parameters have been used since September 2002 (patient #4). As previously noted, C.R. Bard Peripheral Vascular Division currently manufactures the e-PTFE to these standards.
While there have been some problems and complications that will be discussed, none of the patients have exhibited capsule contracture.
The two most significant complications resulted in removal of the Pocket Protectors™ and, in one case the mammary prostheses. Each of the patients had a flu syndrome and developed refractory seromas with negative cultures. In the first case, the patient exhibited fever (101.8), body aches and pains the day after surgery. This eventually abated, however fluid continued to build up after initially appearing to resolve. The breasts were explored. It should be noted that while e-PTFE is very safe, if it becomes contaminated (bacteria, virus, or other contaminate), particularly in light of its porosity, then the material will not be accepted as an implant, nor can it be cleaned and salvaged. Also, because of the hyperemia of the fresh wound (the breast pocket) and its immunocompromised state (freshly traumatized), the area is naturally more susceptible to any blood borne contaminate during the early healing phases (first three months).
In the first case, the breast pocket was explored two weeks after surgery. Both breasts exhibited a tenacious greenish transudate that failed to grow out any bacteria, mycobacteria or fungus. At that time the decision was made to remove all implant materials, including the silicone gel mammary prosthesis and insert drains. The drains were subsequently removed and the patient healed. However, pending revision, she remained quite disfigured (and unhappy with her surgeon) and relied upon an external prosthesis. Her tissues healed remarkably well, and seven months following explantation, revision surgery with a Pocket Protector™ and new gel implants was achieved.
In the second case, the seroma formation appeared two weeks after the operation, but also in conjunction with significant flu-like symptoms. Initially, attempts were made to salvage the implants by aspirating with a liposuction cannula via a small entry site in the areolar incision. All cultures remained negative. After several weeks of attempting conservative care, the left breast developed an infection - probably from contamination via aspiration. The decision was made to remove the e-PTFE. This time, however, the pocket was cleaned, drains were placed and the breast implants were replaced after sterilization in order to maintain breast volume. Of course, this resulted in an expected bilateral capsular contracture, but at least the patient had breast mounds (remains reasonably happy with her surgeon) and understands that after adequate time for healing (6 to 12 months), revision surgery will be performed.
When performing a “Pocket Protector™” revision for capsular contracture, it is generally advised to perform a total capsulectomy. This allows for fresh “raw” surfaces to grow into the e-PTFE. However, if the patient is particularly thin in certain areas, it is probably prudent to leave strategic sections of scar tissue attached to the underlying breast tissues so as not to thin out the tissues too much and risk damage or excessive thinning to those areas. Since the bulk of the capsule is being removed there should be more than ample opportunity for tissue adherence. It’s most important to have tissue adherence to the Pocket Protector™ around the perimeter because this will ensure the prevention of the potential space from closing down upon itself and confining the implant.
In three particularly thin patients, there appeared to be some annoying rippling in spite of using smooth silicone gel implants. In one case, a larger McGhan smooth gel implant was exchanged for a slightly smaller Mentor smooth gel implant. The shell on the Mentor implant seems to be a little thinner and while there were still some palpable ripples, they were considerably less noticeable. Still, even the current shell on the Mentor implant is thicker than desirable and left some visible rippling on two other patients. Worth noting, when exchanging implants on this patient six months after the initial procedure (total capsulectomy and revision with Pocket Protector™) the e-PTFE maintained pocket patency with peripheral adherence and showed no visible signs of scarring or any irregularity.
One of the patients exhibited some superior pole rippling, but was ecstatic with her result. Her breasts had been rock hard and quite deformed for years. She had also complained of a general sense of malaise, and stated that subsequent to her revision with the Pocket Protector™ she had “increased energy” and felt as though a “veil had been lifted.” Of course, this most likely is the result of removing “contaminated” subcapsular material (ruptured gel) along with the tainted capsule. With her renewed sense of health and improved appearance the rippling she experienced was inconsequential (FIG. 6).
The third patient with rippling exhibited a small horizontal crease on the medial aspect of each breast. She had Mentor 400cc smooth moderate profile gel implants. Her breasts were quite soft and felt natural, however, to this patient, the rippling was very bothersome. She would likely benefit from a thinner walled silicone gel implant that would not be palpable through her thin tissues. Whether this is ultimately correctable will depend on the availability of such implants, otherwise an exchange to a high profile implant with greater relative fill might be advisable.
The Pocket Protector™ itself has not been palpable with the exception of a few individual spots where the seamed edge was excessively gathered into the tissues causing a slightly palpable ridge.
As noted in the results, no drains were used. It should be noted that electrocautery dissection using a SAF-T-VAC® facilitates the development of the breast pocket and minimizes bleeding. Thus, drains have not been necessary, though arguably they might have had possible benefit in the cases of refractory seroma without evidence of infection.
While I envision that this product should be particularly useful to the post-partum or older patient that has lost a modest amount of volume and wants a minimal (200 - 250 cc) increase, so far most patients seem to opt for implants 350 - 450 cc’s (FIG. 7). It makes sense that patients with more difficult and desperate problems are more likely to avail themselves of a new and, hopefully, promising procedure. Naturally, success in these most difficult patients influences the decision making in the primary augmentation patient.
Also, this would seem to be an ideal implant for the Type B patient, while saline implants might be adequate for Type A patients. Still, the Pocket Protector™ has served well on Type A patients that elected to use it (FIG. 8). Potentially, even in these patients, the Pocket Protector™ serves as a liner so that in the future, should it be necessary or desirable, the patient need only have the implants exchanged without the necessity of having more extensive revision surgery, such as capsulectomy or capsulotomy.
Further, while I had envisioned its potential benefit in the difficult reconstructive case of subcutaneous mastectomy, I’ve been pleased to have had the opportunity to already test it and see that it worked (FIG.9). Subcutaneous mastectomy carries considerable risk for reconstructive problems, particularly high rates of capsular contracture. There has been significant concern about its ability to reduce cancer risk as well.58 Still, with the advent of a relatively simple and reliable reconstructive alternative, it might be worthwhile to re-explore improved methods of subcutaneous mastectomy as a prophylaxis against cancer in high risk individuals.
Arguably, there are a
multitude of in vitro and in vivo studies that can be done.
I had suggested that the Pocket Protector™ would contribute the following benefits to augmentation mammoplasty: 1) prevent capsule contracture; 2) allow for placement of a smooth surfaced silicone gel implant, thus achieving optimal softness and natural feel; 3) prevent or minimize rippling; 4) provide a barrier against potential infection; 5) provide a barrier in case of possible gel rupture; 6) provide an internal brassiere to prevent sagging; 7) allow for easy exchange of implant if necessary (e.g. increase or decrease size); and 8) allow for improved results with traditionally difficult cases, such as subcutaneous mastectomy.
While most of these benefits have so far been supported by the findings, increased number of cases, long-term analysis and further in vitro studies are warranted. Additional study will be necessary to support benefits 4, 5, and 6. For benefit 4, it’s expected that once there’s tissue ingrowth into the e-PTFE, then it should be less likely that a periprosthetic infection could occur, but this remains to be proven. A simple animal model could support this conjecture as well as long-term outcome analysis.
Regarding benefit 5, it makes sense that if the pocket maintains its patency, rupture of the implant would not spread outside the confines of the e-PTFE. E-PTFE integrated with body should represent a formidable barrier to the possible spread of silicone gel beyond the breast pocket. Recent concerns by the FDA over ruptured implants and the possible spread to distal sites should be ameliorated by use of the Pocket Protector™, perhaps improving the chances of approving silicone gel for general use. Still, this would require additional in vitro or long-term outcome analysis.
Finally, benefit 6 - internal brassiere - will be evaluated by simple long-term analysis.
Thus, a new surgical device,
the Pocket Protector™, has been presented for consideration as a means to
improve the current state of the art of breast enhancement with prosthetic
devices. While saline devices have decreased the incidence of capsule
contracture, they are definitely more artificial to palpation than soft gel
implants and run the risk of deflation. Textured implants, particularly gel,
work well on many patients, however, a significant number of patients (with
thinner tissues) can suffer from rippling. Submuscular augmentation can
decrease some of these problems, but can also result in distortion of the breast
with or without muscle contraction. Also, type B breast patients requesting
modest increases in volume are not particularly aided by single implants that do
not, or can not, maintain the pocket patency. Meanwhile, the public, and
apparently the FDA, still remain confused and concerned about potential risks of
ruptured gel. E-PTFE has a long history as an exceptionally safe implant
material. Our goal should be to provide a safe procedure with the most natural
results. This preliminary evaluation suggests that the Pocket Protector™
affords us and our patients this opportunity.
Anatomic model representing the position of a prototype Pocket ProtectorŌ filled with a silicone gel implant.
A. 54 year-old patient
following four previous mammoplasty procedures. She presented with Baker Class
IV capsule contracture and right ruptured gel implants.
A. 34 year-old patient with
submuscular saline implants and distorted appearance (breast hanging over
56 year-old patient 8 ½ years after primary augmentation with Pocket ProtectorŌ and 270cc smooth gel-filled implant demonstrating softness (lack of capsule contraction).
A. 54 year-old patient demonstrating bilateral capsule contracture with calcified capsule and ruptured gel implants.
B. Same patient with smooth gel-filled implants within Pocket ProtectorsŌ presents with some superior rippling, but not only has soft breasts, but feels generally better as well.
A. 36 year-old multiparous patient demonstrating moderate loss of breast volume relative to increase in skin pocket.
B. Same patient after augmentation with Pocket ProtectorŌ and smooth gel-filled implant.
A. 29 year-old patient with
primary mammary hypoplasia, type A breasts.
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The American Society of Cosmetic Breast Surgery 2017 Last modified: June 23, 2017