Reducing Contamination of Breast Implants to prevent complications and infection – The 14 Point Plan for Safer Implant Surgery
Breast implants are a prosthesis used in reconstructive and cosmetic plastic surgery. They are used to change the size, shape, and contours of the breast which improves the appearance of your breast. Infection is a possible complication during and after the breast implant surgical procedure which can result in further future complications including capsular contracture, seroma, risks of Breast implant Illness (BII) or Breast Implant-Associated Lymphoma – BIA-ALCL among others. Always choose a surgeon that is committed to following the 14 point plan to prevent infection.
What is the 14 point plan?
It is an evidence-based list of 14 points that are incorporated in various steps of breast implant surgery to reduce the number of bacteria at the time of implant placement, preventing bacterial biofilm formation and thereby reducing the potential complications associated with implants.
Origins of the 14 point plan
The 14 point plan, first published in 2013, suggested a plan to reduce the number of bacteria present at the time of breast implant placement thereby reducing chances of infections caused by it.
The plan was developed by Professor Anand Deva and his team at Macquarie University. It aims to help patients undergoing breast implant placement to give them the best possible results without compromising safety. Prof. Anand was also part of a collaborative research team that discovered the growth of biofilm in commonly used breast implants. Each step of the plan is backed by evidence and has been shown to reduce incidences of capsular contracture following infected implant placement. Breast Implant companies like Mentor and Motiva support the use of the 14 point plan and use of implant insertion devices (like the Keller Funnel) to reduce contamination at time of surgery.
Dr Mark Doyle at Gold Coast Plastic Surgery follows the 14 point plan but sadly, not all surgeons and not all day surgery clinics and ‘cosmetic surgeons’ have adopted the plan.
Bacterial Biofilm Infection
Bacteria usually exist as a single organism with each cell functioning independently of the others for survival and reproduction. However, sometimes, these bacteria begin to work together by adhering with each other, forming a “biofilm.” This group of bacteria secretes a sticky substance that surrounds the bacteria and helps them to stick to implant surfaces; the resultant coating with embedded bacteria is the biofilm. During breast implant placement, if these biofilms are formed they are very difficult to remove.
On reaching a certain threshold level, the biofilm can lead to chronic inflammation and various complications in the breast. Possible complications include chronic infection, capsular contracture, double capsule, and breast implant-associated ALCL (BIA-ALCL). The incidence of BIA-ALCL is higher in cases of textured implants as significantly increased surface area in these implants can result in the formation of more bacterial biofilms and consequently chronic inflammation.
Many studies have demonstrated the link between chronic inflammation caused by bacterial biofilm in the pathogenesis (origin) of BIA-ALCL. To prevent these complications related to biofilm from arising the researchers came up with the 14 point plan after years of scientific research. Since its inception, the 14 point plan has been applied worldwide during implant placement to reduce chances of infection by incorporating strategies during the procedure to limit the number of bacteria that can contaminate the breast implant surface.
The 14-Point-Plan to prevent Breast Implant contamination during Surgery
- The use of intravenous antibiotics as a prophylactic at the time of anesthetic induction to help destroy any bacteria which might be introduced into the bloodstream during implant placement. The use of Cephalosporin is recommended to target Staphylococcus epidermidis, some surgeons advocate the use of Vancomycin to target Methicillin-resistant Staphylococcus epidermidis.
- The avoidance of peri-areolar and axillary incisions; both laboratory and clinical studies have shown that using these incision sites for breast implants leads to a higher rate of capsular contracture as the pocket dissection is contaminated directly by bacteria within the breast tissue. Whenever possible, inframammary incision should be used for implant placement as it is associated with fewer cases of capsular contracture.
- Using nipple shields helps prevent bacterial spillage of the breast duct into pockets created for the prosthesis.
- Careful atraumatic dissection should be performed to minimize damage to the breast tissue during the surgery. As damaged tissues promote bacterial growth. Electrocautery helps in atraumatic dissection and in developing the precise plane.
- Carefully stop any bleeding occurring during the surgery itself, to reduce the risk of blood collecting around the breast implants after the surgery. (Prospective hemostasis)
- Avoid dissecting into the breast tissue itself.
- The use of a sub-muscular, dual-plane, or sub-fascial pocket has a distinct advantage in reducing the chance of infection. Making such pockets decreases the risk of bacteria present in the breast ducts and tissues coming into contact with the breast implant
- Irrigation of the entire breast implant pocket should be done accurately with a mixed triple antibiotic solution or 50% (1:1 dilution) or a stronger povidone-iodine solution. The entire field of surgery should be carefully cleaned with an antibiotic solution. The antibiotic solution should be used to clean skin around the incision, clean all of the breast implant pockets and all instruments that are to be introduced into the breast implant pocket. Irrigation should be done using Triple Antibiotic Betadine Irrigation or Triple Antibiotic Non-Betadine Irrigation or a Betadine Only irrigation. Using bacitracin or cefazolin as single antibiotics for irrigation purposes is not recommended as they do not act effectively against all bacteria.
- Necessary steps should be taken to reduce the chances of an implant coming into contact with breast skin and its bacteria. It requires making adequate sized incisions, using a skin barrier or introduction of a sleeve.
- The time between opening the breast implant from its sterile packaging and placing and repositioning it in the created anatomical pocket should be minimized as much as possible. The implant should be left placed in a thermoplastic container until immediately before placing it in the pocket. When possible minimize repositioning and replacement of the implant.
- Use new instruments and drapes, and change surgical gloves before handling the implant. In case of unavailability of new instruments, the instruments should be cleaned with an antibiotic solution before bringing in contact with the implant. Only one person should handle the implant and the surgeon should dip his finger in antibiotic solution before changing the drapes. This helps reduce the transfer of bacteria from the skin to the implant.
- Avoid using a drainage tube for primary augmentation, breast revision, and breast reconstruction as it can be a potential site for bacterial entry.
- Use a layered closure. Layered closure of incision site protects the breast implant from bacterial access through the surgical wound in early phases of wound healing.
- The use of antibiotic prophylaxis should be recommended to cover subsequent procedures that breach skin or mucosa in patients who have undergone breast implant placement. This helps reduce the risk of bacteremia which may spread to the breast and result in infection and capsular contracture.
In summary, the plan aims to not touch the implant at all and make sure that the pocket is kept as sterile as possible while placing the implant into the tissue. Using intravenous antibiotics at the time of surgery and washing the implants in these plus antiseptics such as Povidone-Iodine (Betadine) is a key component in keeping the procedure sterile.
Not inserting the implant via axillary and peri-areolar incision helps avoid external bacterial contamination, and using a nipple shield prevents bacterial contamination of the breast pocket. Cutting into breast tissue should be avoided and progressive hemostasis should be done; surgical gloves should be changed and new instruments should be used for insertion of the implants and drainage tube placement should be avoided.
By incorporating these 14 simple steps into implant placement surgery, your surgeon will be able to achieve improved surgical outcomes and a reduction in complications and need for reoperations by minimizing bacterial contamination at various steps of implant placement.
Importance of the 14 point plan in implant surgery complication prevention
Strictly adhering to the plan helps reduce the incidence of capsular contracture. Capsular contracture is the process of formation of dense hard scar tissue around the implant which results in pain, hardening, and deformity around the implant site; it can involve both the breasts.
Developing infection as a result of improper implant placement without using this plan increases the risk of capsular contracture by the process of bacterial biofilm formation. A recent study conducted on pigs in whom silicone implants were implanted showed an increased incidence of capsular contracture in pigs who had Staph bacteria on their skin at the time of implant placement. This study showed that in addition to maintaining a healthy environmental condition, it is necessary to prevent skin from coming in contact with the implant as the human skin harbors Staph bacteria.
The use of this 14 point plan prevents the implant from coming into contact with the skin, potentially harboring Staph bacteria in addition to ensuring proper sterilization and proper surgical condition thereby considerably decreasing the incidence of capsular contracture. The average rate of developing capsular contracture using these plans is below 3% hence showing the effectiveness of the plan.
Incorporating these plans reduce the risks of double capsule formation around the implants. The development of a double capsule refers to finding 2 distinct layers of the capsule (instead of 1) separated by the intracapsular space surrounding the implant. This extra layer of capsule produces a low friction interface between the two capsule layers around which the implants can rotate. Rotated implants give an aesthetically poor appearance to your breast. The formation of double capsules has been attributed to bacterial biofilm formation in textured implants which can be prevented by incorporating these 14 point plans in breast implant surgery.
Proper implementation of these plans also helps prevent Breast implant-associated anaplastic large cell lymphoma. It is a cancer of the immune system developing as a result of bacterial biofilm contamination at the time of implant placement. It is a rare condition heavily associated with the use of textured implants.
Textured implants have a greater surface area, giving more room for biofilm attachment hence a greater chance of chronic inflammation and consequently the development of breast implant-related lymphoma. The condition usually develops 7-10 years after implant placement and the woman is usually present with pain and a lump around her breast. The treatment of BIA-ALCL is usually implant replacement or implant removal so proper implant placement using 14 points helps increase the longevity of the implant in your breast as well in addition to preventing lymphoma.
Recommendation – Insist your breast surgeon follows the 14 point plan
If you are planning to get breast implants you should always seek a surgeon who places implants using the 14 point plan as it greatly reduces chances of bacterial infection during surgery and the development of complications afterward. Also, a point to be noted is that this technique is usually strictly adhered to by specialist plastic surgeons at hospitals compared to day surgery clinics and so called cosmetic surgeons, so you should thoroughly enquire about your surgeon and whether they conduct breast implant surgeries with strict adherence to these plans.
Cosmetic Surgeons and day surgery facilities have been shown to be overly represented in the reported cases of BIA-ALCL – Did they follow strict criteria to avoid contamination?
Further Reading and Medical References:
- 14-Point-Plan Breast Implants, Breast Augmentation | ASAPS (aestheticplasticsurgeons.org.au)
- Sientra Implants 14 pt Safety pdf – EXT-0029-R2-14-Point-Plan.pdf (sientra.com)
FAQs – Frequently Asked Questions about Breast Implant Complications and Infection
How can you tell if your breast implant is infected? How do you treat infected implants?
- Infected breast implants can cause symptoms like high fever, pain, swelling, tenderness, and redness of the breasts. If you suspect infection – contact your surgeon or doctor ASAP. Implant Infection is generally treated using antibiotics, however, if symptoms persist despite taking antibiotics then contact your surgeon as you may require removing the infected tissue or the implant itself.
What is capsular contracture?
- The formation of a “capsule” of scar tissue by the body around the breast implant is a normal part of the healing process. In the case of breast implants, the capsule helps in keeping the breast implants in place and prevents slippage. In some patients, however, this capsule of scar tissue becomes unusually hard and starts to contract around the implant which can lead to both pain and hardening around the breast and give an aesthetically unpleasing appearance.
What is BIA-ALCL?
- Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a type of Non-Hodgkin’s lymphoma (tumor of the immune system) that can develop around the implant (scar tissue capsule) and the fluid surrounding the breast implant. The incidences of BIA-ALCL have been found associated only with textured implants. The typical presentation of BIA-ALCL includes pain and swelling around the implant site, rarely there may be enlarged lymph nodes, presence of fever, and skin rashes. Symptoms have typically developed 5-7 years after implant placement. Chronic inflammation caused by bacterial biofilms has been linked to the pathogenesis of BIA-ALCL.
For more information about the 14 point plan or organising breast implant surgery or implant check – contact the team at Gold Coast Plastic Surgery