In 2009 the FDA approved the Keller Funnel – a sterile funnel (looks like a pastry funnel) used to insert silicone breasts implants in a“no-touch” technique. I use a Keller Funnel for all my breast augmentation surgeries. The implant goes from it’s sterile container, into the sterile funnel, straight into the pocket without contacting skin or any other surgical instruments. Studies have shown that there is at least half the amount of bacterial contamination from breast tissue when using the funnel.
The reason why this is important is because capsular contracture – scar tissue formation around breast implants is one of the most problematic complications of breast augmentation surgery and it occurs in 10-15% of all women usually resulting in reoperation. Capsular contracture has been in part attributed to a biofilm of bacteria formed around the implant. Therefore minimizing bacterial contamination should help prevent capsular contracture.
Also use of Adam’s solution – a triple antibiotic solution of cefazolin, gentamamicin and bacitracin – has been shown to decrease capsular down to 1.8 % in study groups.2 I use Adam’s solution to clean out the breast pocket, clean all surgical instruments involved in implant placement, clean the breast skin, soak the implant, and also fill the Keller funnel with it. I use it everywhere I can.
It has also been shown that exposed nipples are sources of implant bacterial contamination during breast augmentation.3 The terminal ducts at the nipple and areola are colonized with bacteria. Therefore, I cover the nipples with a Tegederm nipple shield during the surgery to decrease the chance of bacteria from the nipple spilling into the surgery site.
I also make sure the breast pocket is completely free of any blood and minimize any instruments used and don’t put gauze or lap pads into the pocket during surgery even though there haven’t been any good clinical studies to prove that these steps help. I may be excessive and obsessive about all these little things, but as a woman with implants myself – my greatest fear is capsular contracture, which can occur even years after the surgery – so I try to do everything possible to try to prevent it’s occurrence.
- Dr. Catherine Begovic
1. Moyer HR, Ghazi B, Saunders N et al., Contamination in smooth gel breast implant placement: testing a funnel versus digital insertion technique in a cadavar model. Aesthet Surg J. 2012 Feb;32(2):194-9.
2. Adams W, Rios J, Smith S et al. Enhancing Patient Outcomes in Aesthetic and Reconstructive Breast Surgery using Triple Antibiotic Breast Irrigation: Six-Year Prospective Clinical Study. Plast Reconstr Surg. 2006;118(7 Suppl):45S-52S.
3. Wixtrom R, Stutman RL, Burke RM et al., Risk of Breast Implant Bacterial Contamination from Endogenous Breast Flora, Prevention With Nipple Shields, and Implications for Biofil Formation. Aesthetic Surg J. 2012: Sept 10 [epub ahead of print]
I recently spoke with a friend who is a newborn ICU nurse who asked me whether or not woman were able to breast feed after breast augmentation surgery. She told me that the nurses in her hospital were not encouraging post breast augmentation patients to breastfeed because they thought they weren’t able to. In a study performed by Mentor as part of their FDA post-approval study, only 8% of women who had breast implants had trouble breast feeding. Although I always tell my patients there is a possibility their breast augmentation surgery can impair their ability to breast feed, most women are able to breast feed after their surgery (including myself!), so they should definitely be encouraged to try.
Another study presented at the American Society of Plastic Surgeons annual conference found that many women who had breast augmentation surgery were concerned that breast feeding may alter the appearance of their breasts and this contributed to their trouble with and reluctance to breastfeed. However, although breasts generally sag with each pregnancy, there is no evidence that breastfeeding worsens these effects in women whether or not they have implants.
Also, for women with silicone implants, there is a concern whether the silicone passes orally to their child in breast milk. Multiple studies have shown that the amount of silicone in breast milk from women with silicone implants is not statistically significantly higher than breast milk from women without implants. In fact, the levels of silicone found in grocery store cow’s milk (709 ng/ml) and infant formulas (4402ng/ml) was significantly higher than breast milk even from women with implants (55ng/ml)!
Dr. Catherine Begovic
50th anniversary of silicone breast implants – 1st ever breast implant recipient shares her experience.
Timmie Jean Lindsey is now an 80 year old great grandma. She was the first patient to receive silicone breast implants in 1962 from the surgeon who invented them. Amazingly enough, her original implants have never leaked or ruptured, but she does have some scar tissue. She said that her breast tissue only started to sag when she turned 70.
She feels fortunate to have participated in the evolution of breast implants especially when one of her granddaughters had to have breast reconstruction after a double mastectomy for breast cancer. She was happy that her granddaughter and other breast cancer survivors are able to feel whole again after breast cancer surgery.
As with any medical device, the current silicone breast implants have undergone extensive testing and FDA approval. They have undergone major improvements since their first appearance in 1962. We have to thank Great Grandma Timmie for being the first one to undergo this surgery which has allowed so many women to enjoy a fuller, more feminine shape.
Dr. Cat Begovic
On Wednesday 6/22/11, the Food and Drug Administration announced that early findings from an analysis of safety issues and adverse events associated with silicone-gel breast implants revealed no new concerns. Therefore, the agency said it will allow the devices to remain on the market.
The Los Angeles Times (6/23, Mai-duc) stated that the FDA said the analysis conducted on more than 80,000 women over 10 years by implantmanufacturers “indicates that they have a ‘reasonable assurance of safety and effectiveness’ when used properly. … ‘What we can say is the current data doesn’t indicate that silicone gel-filled breast implants are linked to breast cancer, connective tissue disease or infertility,’”
However, women considering breast augmentation with silicone breasts implants should discuss the risks, benefits, and alternatives with their plastic surgeon. It is important for women to understand that 20 percent to 40 percent of patients who have implants for cosmetic reasons will need another operation to modify or remove them within eight to 10 years. I always encourage women to do their research and have all their questions answered before proceeding with any cosmetic surgery procedure.
Dr. Cat Begovic M.D.
New data from the American Society of Plastic Surgeons show that breast enhancement surgery continues to increase. Last year, surgeons performed 296,203 breast implants – a 2% increase from 2009 and a 39% increase since 2000.
Overall, doctors performed 13.1 million cosmetic procedures in 2010, a 5 % increase compared with 2009.
How does this relate to you? If you are considering a plastic procedure you likely know someone who had it done. I always recommend patients get as much information as possible before proceeding with a procedure. Sometimes it’s helpful to talk to friends who had the procedure done to get their perspective.
Regardless, you should always feel comfortable talking to your surgeon and asking as many questions as possible about results, recovery, and what to expect.
Women, who have or intend to get breast implants, should be aware that they are covered by warranty programs offered by companies who manufacture them. That means that if you get implants from them, they will help cover fees and give you a lifetime product replacement option.
I have breast implants so this information gives me peace of mind. Once you get an implant, you will be given a card with information about your implants like the serial number, kind, size, etc. You should keep this card so when the need for a replacement arises, it will be more convenient for you and the company to facilitate the application of the warranty.
Allergan and Mentor offer free warranty programs and upgrades. Below is some information that you should know about the warranty they offer patients.
Allergan breast implants are sold under the brand name Natrelle®. Every implant, be it saline or silicone gel, comes with the ConfidencePlus® warranty upon surgery. There is also the option to upgrade to ConfidencePlus® Premier warranty.
ConfidencePlus® covers recipients of both NATRELLE™ style saline and silicone filled breast implants instantly, for free. Coverage is as follows:
- 10 years of guaranteed financial assistance
- Financial assistance of up to $1200 for surgical fees, operating room and anesthesia fees, if not covered by your insurance
- Lifetime product replacement on the deflated side without charge
- Non cancellable terms
If you choose to upgrade to ConfidencePlus® Premiere, you will enjoy more benefits for only $100. You would have to do this change within 45 days of your surgery. Coverage is as follows:
- 10 years of guaranteed financial assistance
- Financial assistance of up to $2400 coverage for surgical fees, operating room and anesthesia fees, if not covered by your insurance
- Implant replacement on the opposite (non-deflated) side for 10 years after surgery
- Lifetime product replacement without charge
- Automatic renewal to ConfidencePlus® after replacement, for free.
- Non cancellable terms
Mentor have saline and silicone implants. The silicone gel implants are branded as MemoryGel®. Upon getting Mentor breast implants, you instantly get the Mentor Standard Advantage warranty for free, which includes:
- Free lifetime product replacement
- Financial assistance of $1200 for the cost of replacement surgery for 10 years after surgery.
- Implant replacement on the opposite (non-deflated) side for 10 years after surgery.
If you choose to upgrade to Mentor Enhanced Advantage, you only have to pay $100. You will get to enjoy all the benefits of standard warranty and increase the financial assistance amount from $1200 to $2400.
Since the warranty details do change, make sure to regularly check the details on the manufacturer’s website so that you’ll know your coverage.
Dr. Catherine Huang Begovic
Just last week, at least 4 or 5 of my girlfriends who have breast implants asked me this question. I’m not sure how this idea started, but most women think that their breast implants need to be changed routinely. This is not the case – really, implants only need to be removed and replaced if there is a problem. In most cases, the problem involves implant leaks or scar tissue forming around the implant, known as “capsular contracture”. This scar tissue makes the breast feel firm, distorted, or uncomfortable. In the surgery, the scar tissue, or capsule, will also be removed.
Leaks are another reason to replace implants. If a woman has saline implants, it will be obvious if there is a leak. The implant slowly deflates as the saline solution leaks out. If a woman has silicone implants, it is sometimes difficult to detect a leak. This is why the FDA recommends screening for silicone leaks 3 years after implant placement and then every 2 years. Sometimes there are symptoms such as hard lumps, distortion of the breast or implant, swelling, burning, or hardening of the breast. If that happens, the implant should be removed.
Before getting a breast augmentation surgery, ask your doctor about the pros and cons of the procedure. Women who are considering implants should know that they are committing themselves to multiple surgeries over their lifetime. The good news is that if an implant needs to be replaced, the manufactures currently provide new implants for free and often cover part of the surgery fees as well.
Dr. Cat Begovic
Breast augmentation research – Recent publication in the Aesthetic Surgery Journal by Dr. Catherine Huang Begovic
One of the most common and disfiguring complications of breast implants is capsular contracture. This is scar tissue that forms around the implant and causes discomfort or distortion of the breast. No one knows what predisposes certain women to develop this scar tissue. There have been different theories such as a genetic predisposition to inflammation forming scar, a small amount of blood around the implant that causes increased inflammation, or a bacterial film that forms around the implant causing an inflammatory response. In surgery I do everything possible to decrease any of these factors – making sure there is absolutely no bleeding or oozing before placing the implant, washing the implant pocket multiple times with saline, antibiotic solution, and betadine to clear out any debris, bacteria, or blood, and changing to new clean and sterile gloves before touching each implant.
I am committed to research to battle the problem of capsular contracture. My latest research has just been published in the Aesthetic Surgery Journal. I’ve copied the abstract below.
Aesthet Surg J. 2010 May;30(3):404-8.
Effects of Singulair (montelukast) treatment for capsular contracture.
BACKGROUND: Capsular contracture (CC) is one of the most common complications of breast augmentation surgery. Leukotrienes are implicated in the inflammatory cascade and have been postulated to be involved in the formation of CC. Therefore, leukotriene antagonists Accolate and Singulair have been prescribed by plastic surgeons off-label to treat and prevent CC. To date, there are no studies investigating the efficacy of Singulair on CC.
OBJECTIVE: The authors retrospectively review a series of patients treated with Singulair to determine whether it improves CC after breast implant surgery.
METHODS: Nineteen patients treated with Singulair by the senior surgeon (NH) after implant placement from March 2006 to November 2009 were included in this study. Follow-up on Singulair efficacy was obtained by a combination of office chart review and standardized telephone questionnaire. Results were characterized as complete improvement, improvement, no change, or worse.
RESULTS: Seventeen patients presented with CC resulting from a variety of breast operations. Two patients who had a history of recurrent CC were prescribed Singulair prophylactically immediately after surgery. Twenty-one breasts with existing CC were included in the total. Two (11%) patients became worse, three (16%) patients had no change, five (26%) improved, seven (37%) completely improved, and two (11%) were prevented from having CC formation.
CONCLUSION: Our preliminary study shows that Singulair improves CC. Breasts with mild CC (Baker score < III) appeared to have better improvement with Singulair compared to those with more severe contracture (Baker score III and IV). Singulair is well tolerated with minimal side effects and can be administered to patients after breast implant surgery to improve CC.
I’ve recently had several girlfriends of mine come in for a breast augmentation consultation. Even in this day and age where information about anything can be found on the internet, it is often still confusing for patients. I remember when I got my breast implants, I felt a little overwhelmed by all the information that was out there. Therefore, I use a simple algorithm for my patients to help them through the process.
1) Saline vs. Silicone
Silicone breast implants have recently been FDA approved. Whether a woman undergoes augmentation with saline or silicone implants is a personal choice. The benefits of saline are that if there is a rupture, saline is absorbed by the body. The downside is that they feel less natural than silicone, especially if the patient has little breast tissue. The implants feel quite different – in my office I have my patients feel both a saline and silicone implant to help them make a decision. I also have a silicone implant where I’ve poked a small hole so they can see how the cohesive nature of the gel helps contain the leak
Breast implants are placed through three different incisions. Inframammary fold (in the crease beneath the breast), periareolar (around the nipple), trans axillary (through the armpit). This decision will be made on an individual basis and depends on each patient’s anatomy and the implant size. Overall, all heal well. My implants were placed around the nipple and are barely perceptible. Many of my patients have an inframammary incision and their scar is barely visible.
Most of my patients come in and tell me they want to be a “full C”. However, because bras are sized differently, distorted by padding, and the cup size varies based on the chest width a “full C” is often not what most women think. In general, because I’m a women, I can get a good idea of what my patients are visualizing and it’s easy for me to estimate what size implant they want. We then do the fine-tuning by trying different implants in the office. This is the fun part – to see what you will look like with implants!
4) Implant placement
Implants can be placed under or over the muscle. In general, studies have shown that implants placed under the muscle have decreased incidence of capsular contracture (hard scar tissue forming around the breast causing distortion) but sometimes implants are placed over the muscle create a little breast lift in patients who have mild droop. The decision where to place the implant is made on an individual basis based on the patient’s anatomy.
When you come in for a consultation, I’ll take you through a hands-on, step by step process. There is nothing like feeling the implants in your hands or seeing how they look under your clothes. I personally feel that having breast augmentation was one of the best decisions I ever made. I loved not having to wear padded push up bras under EVERY outfit and even as an active person I actually felt MORE comfortable running and working out in a sports bra not being so flat chested. Living in LA where the average woman spends more time than most in a bikini, tank top or halter dress, I felt so much more versatility in my wardrobe. Honestly, I could talk about breast implants for hours and I truly love being part of this life-changing experience for my patients.
Dr. Catherine Huang-Begovic