Removal of breast implants and the capsules that grow around them is an essential step to healing and recovery. The body starts working to build capsules (scar tissue) immediately after implantation and continues to build capsules over the years. Capsules are the immune response to a foreign object and all breast implants develop them. In all cases they should be fully removed upon explant because they can cause several problems when left inside – can harbor microorganisms and biofilm, they can continue to grow and spread, they can calcify (causing pain and inflammation), can cause radiology interference, can stimulate autoimmune responses and ultimately further symptoms. Proper and timely explant is key.
1. Importance of Full Capsule (Scar Tissue) Removal:
Full capsule removal through En Bloc or Total Capsulecotmy is always recommended, regardless of the type of implant or for how long that one has had them in. This is considered a proper explant. En Bloc is advised for all silicone breast implants (smooth and textured) and textured saline breast implants. Total capsulectomy is advised for smooth saline or as an alternative to cases that can not be done en bloc. Choose a plastic surgeon who is experienced in full capsule removal and is committed to removing 100% of the capsule tissue.
Capsules do not dissolve. There have been many instances in the breast implant illness groups and in scientific literature where the capsules are not fully removed and women require a second surgery. See here for an example of capsules that had to be removed four years after they were left in from a silicone implant removal and a lady was left symptomatic.
Dr. Nancy Hardt (Immunologist, Pathologist):
Retained implant capsules may result in a spiculated mass suspicious for carcinoma, dense calcifications that obscure neighboring breast tissue on subsequent imaging studies, and cystic masses due to persistent serous effusion, expansile hematoma, or encapsulated silicone filled cysts.
Retained capsules are a reservoir of implant-related foreign material in the case of silicone gel-filled implants and textured implants promoting tissue ingrowth.
Dr. Pierre Blais (Chemist, Biocompatibility Expert):
Contamination of the space between the capsules and the implants by microorganisms, silicone oils, degradation products and gel impurities constitutes a major problem which potentiates the risk of implants. Such problems include infection, deposition of mineral debris, as well as certain autoimmune phenomena. … It is well documented from case histories that removal and/or replacement of implants without exhaustive debridement of the prosthetic site leads to failure and post surgical complications.
Dr. Douglas Shanklin (Pathologist)
There is a remarkably large body of medical and scientific literature on these matters which emphatically shows the capsule is the site of illness. …[U]nless the capsules come out at the same time, the immunopathic process will continue unabated.
- TOXINS – Capsules surround the implants and hold some of the toxins that are released. In the area between the inside of the capsule and the surface of the implants there can be biofilm (bacteria), gel bleed (silicone, heavy metals, chemicals), textured shell fragments, inflammatory cells, mold, etc. These are contained and may be absorbed by the capsule, which over time may also result in capsule calcification.
- CAPSULES PERSIST – Capsules can persist and spread after removal of only the breast implants. If you are symptomatic it is critical that you have full removal of the capsules. There was a lady in the community whose capsules were left in and continued to spread upward towards her neck and into the sides of her armpit. She developed a heart condition from this excessive growth and proceeded with a second surgery. Upon full capsule removal her symptoms begin to improve and her heart condition resolved. There have been other cases of women who continued to be symptomatic and required second surgeries to fully remove the leftover capsules.
- FOREIGN BODY REACTION – Thick capsules can behave like foreign bodies and continue to provoke a foreign body reaction and possible autoimmune response. They can also calcify and harden, causing pain and inflammation. The body will continue to be symptomatic until full removal.
Ladies who have only had their implants in for a short amount of time, such as a month or two, have also had a good amount of capsule growth and thickness seen at the time of explant in some cases.
Surgeon Dr. Victor Urzola is currently conducting research on breast implant illness and comments on the importance of full capsule removal:
“In our ongoing study with more than 130 patients with Enbloc explantations (implant and biological capsule surrounding the implant completely removed) the percentage of full remission of symptoms at 6 months is 75% and improvement of symptoms is 85%. The difference in outcome might be due to the fact that the capsules surrounding the implants were fully removed….I think it is EXTREMELY important to perform a full removal of the capsule and not only the breast implants, since the particles that work as adjuvants can stay in the capsule and continue to trigger the immunological chronic stimulus.” (Link)
2. Explant Terms and Choosing a Procedure:
Undersand the difference between En Bloc vs. Total Capsulectomy vs. Capsulectomy.
*EN BLOC – is the golden standard for explant. It is a French word meaning “as a whole,” referring to the removal of the implant and the capsule altogether, intact as one unit. It comes out similar to a sac where the capsule encloses the implant.
This was first developed in France to protect from the spillage of the earlier versions of the implants, where the silicone was more fluid and would heavily bleed out of the implants. Explant expert, Dr. Urzola, has a YouTube video explaining the importance of en bloc removal.
It takes more time and experience to do an en bloc explant. The surgery should not be scheduled for less than two hours. This is a meticulous procedure that takes a lot of surgical skill and experience to be able to do, especially for cases of thin capsules, ruptures, and under the muscle implant placements where capsules are partially attached to the ribs and lungs. Expert explant surgeon, Dr. Chun’s instagram showcases many complex cases (thin capsules, ruptured implants) and how they can be removed en bloc. Dr. Urzola has a video showing how it is possible to meticulously cauterize thin capsules adhered to the ribs and perform an en bloc. Ultimately, an experienced surgeon will know how to cauterize any bleeding and how to achieve the best outcome.
*TOTAL CAPSULECTOMY – all scar tissue is removed. This includes the scar tissue lining around the implant along the ribs and lungs. Usually with this procedure the surgeon will remove the implants and then go back in and remove any or all left over capsule tissue.
CAPSULECTOMY – this generally refers to only partial scar tissue removal.
(Capsulotomy – This procedure is more in regard to releasing capsular contracture than to explanting, but will be explained here so it shouldn’t be confused with caspulectomy.)
Enbloc is advised for all silicone implants and all textured implants, including textured saline implants. If en bloc is not possible, then total capsulectomy should always be done as an alternative. Silicone implants could be ruptured or have gel bleed, therefore removing en bloc is the best outcome so that spillage and contamination of silicone across the chest does not occur. Textured implants (silicone and saline) are some of the worst because pieces can flake off and go into the lymph nodes where they then can enter the lymphatic system. In the breast implant illness groups textured implants have been the most evidenced with causing anaplastic large cell lymphoma (ALCL), a cancer of the immune system. Therefore en bloc removal of textured implants is the best outcome to keep the toxins secured in the capsule as a sac until they are explanted out of the body. If you have textured implants, please insist for your surgeon to request pathology to do the CD30 test for ALCL.
Total Capsulectomy is advised for smooth saline. It is also highly recommended for silicone and textured saline implants if en bloc can not be done. Full capsule removal correlates with recovery.
Capsulectomy requires less surgical skill and time, it is the preferred option by the many plastic surgeons who are not experienced in en bloc or total capsulectomy (proper explant). They will argue against those two procedures and will push for only partial removal. The surgeons may say the capsule is thin and unnecessary to remove. Primarily they will insist that an implant can be removed and the capsule can partially stay in. Reasons given are that the capsule is partially attached to the rib cage and lungs – they can’t scrape it all off and don’t want to puncture the lungs. There are techniques, such as cauterization, the explant surgeons who do en bloc and total capsulectomy know how to do to stop any bleeding and they will have the experience to understand how to do those explants. It is preferable not to leave any capsule in, especially if you are symptomatic.
WARNINGS – on plastic surgeons who avoid En Bloc & Total Capsulectomy:
(#1) Some surgeons will highly push for a local anesthesia of just implant removal where they in a short amount of time (about 30 minutes) “pop” out the implants and leave the entire capsule in. If you come across this scenario, run away! Do not explant under local anesthesia and leave the capsules in. Whether the capsules are thick or thin, leaving them inside the body and cut open, leaves one vulnerable to contamination of the contents in the capsule. It can cause further problems as the capsule may spread and persist, provoking a foreign body reaction. Very importantly, there is the risk that the implants are ruptured or that the surgeon may rupture the implants as they are being taken out. It would put the body at risk for silicone gel spreading and contamination, increasing exposure to chemical toxicity.
(#2) If you have SALINE implants, many plastic surgeons will suggest an office visit to simply drain the implant to “assess” how the breast changes in the coming weeks and then do a surgery to remove the implant. Run away! Do not allow a surgeon to deflate the saline implants while they are still in your body. Many saline implants have faulty valves and develop microbiological growth, in rare cases even mold (see saline implants and mold). Dr. Pierre Blais states: “Furthermore, many surgeons habitually incorporated pharmaceuticals such as anti-inflammatories and antibiotics with the aqueous solutions of such implants. These compounds degrade to comparatively toxic entities which add their effects to the previously-cited injuries.” Piercing a hole in the implants and then leaving them in the body in that condition leaves the body vulnerable to contamination.
(#3) Some surgeons will say the capsules are too thin to remove. Do not let a surgeon persuade you that capsules are too thin to remove. Experienced and skilled explant surgeons will know how to remove thin capsules. Dr. Chun’s Instagram showcases many examples of thin capsules being removed en bloc, he is a master explant surgeon. Dr. Urzola’s Instagram also provides a good example of thin capsules being able to be removed en bloc. Not only were these surgeons able to fully remove thin capsules, but they were also able to remove them en bloc. These both debunk the theories that capsules are too thin to be removed. Some surgeons will also try to say that you have thin capsules during the consult, but the truth is that they cannot know this until they operate you. Capsule development and thickness is very individual. There are cases of women who have had a good amount of capsule growth just a few weeks after implantation and others have thick capsules even under one year.
(#4) Many plastic surgeons who are inexperienced in explant will try to dissuade your decision, they will say the surgery will leave you disfigured and will push you to replace with a new set of implants. Or they will try to persuade you to just remove the implant without the capsule (back to point #1). Understand that they make more money in putting new ones in. A skilled and experienced explant surgeon will understand how to achieve the best possible outcome.
3. Research Surgeons and Ask Questions:
Schedule consults and interview Explant Surgeons. Do your due diligence in asking questions to ensure a proper explant with full capsule removal through en bloc or total capsulectomy.
Questions to ask Explant Surgeons (List): full capsule removal (En Bloc for silicone and textured saline implants, Total Capsulectomy for smooth saline implants), takes pictures of implants and capsules, pathology, CD30 ALCL testing of any seromas and of all capsules for textured implants, and if the implants will be returned to you upon request. Other questions include: drains, insurance coverage, cost, scar revision covered in the cost should you need it, and more.
Some surgeons loosely interchange the terms en bloc, total capsulecotmy, and capsulectomy, it is good to be educated on the difference between these procedures before going into the consult. Ask the surgeon to give you a step by step description of the procedure and make sure you are both on the same page with the terms of the explant.
Please note, it may be beneficial to get it in writing beforehand that full capsule removal will be done, get it signed, and make a copy for your own ecords. Unfortunately there have been too many instances where ladies thought they were getting a proper explant and then upon waking up from surgery were told the capsule was left inside as the surgeon had decided it was not needed to be removed. Ladies have had to get second surgeries by other surgeons so that they could finally heal.
4. Request Pictures of the Implants and Capsules:
- Implants with capsules still on (if surgeon does en bloc)
- Implants and capsules, with capsules off
- Picture of inside your chest after the full capsule removal
You can also try to see if the surgeon will video any parts of the surgery.
5. Request Implants Are Returned to You:
Implants are your property and you can arrange beforehand to have them returned to you after removal or at the postoperative appointment. This can be important as you may want to inspect them yourself or if you wish to keep them for any legal proceedings. If you are interested in legal avenues you must have them sealed by the surgeon, maintain a chain of custody, and keep them sealed so evidence is not tampered.
Plastic surgeons may be offered free implants or get kickbacks when they return your implants back to the manufacturer. This protects manufacturers from lawsuits. Some will say they can not return them or have other excuses, but there are also many who will return them to you. There is a government website where you can search if a doctor is receiving payments from a manufacturer (such as fees in research, consulting, speaker, sponsor, etc).
You may receive letters or contact from the manufacturers before surgery to return the implants to them for “analysis.” Few women in the groups have done that and have been very disappointed with the minimal results received, stating the obvious. These reports have been posted for all to see and be warned of the lack of analysis done by the manufacturers. See here for an example of one. Also, please pay caution and be aware you may be signing away your rights to any future legal proceedings by sending them back the implant that after analysis will be destroyed.
Note on Capsules Being Returned – The capsules tell the story of your body’s reaction to the implant. You may want to have the capsules also returned to you or ensure they are kept by the lab so that Dr. Blais may in the future analyze them. Dr. Blais is an expert who examines breast implants and capsules but he is currently back logged.
6. Pathology and Infections:
Discuss with your surgeon beforehand to take pictures of the implants and capsules, what you would like to be sent to pathology and what tests you would like done. Pathology typically only checks for atypical cells leading to cancer cells when examining capsule tissue. They may not check for bacteria or fungus, nor do detailed descriptions unless directly requested to do so by the surgeon. Pathology reports tend to be very general unless you insist for them to be more detailed.
During surgery you can have the surgeon take swabs of your chest and capsule, and also have them take pictures of the implants and capsules. Capsules and swabs sent to pathology and tested for bacteria, fungus, atypical cells, ALCL (CD30), white blood cells, and foreign materials (gel bleed: silicone, silica, talc, polyurethane). These tests are additional costs to the surgery, please inquire beforehand.
You can request for a very detailed pathology report, noting the following: pathological lesions, if there is any foreign material (such as silicone), lymphocyte infiltration, chronic inflammation, and histologic features.
If you have implants and develop unilateral swelling, seroma, breast mass, or even capsular contracture, you should push for CD30 ALCL testing. This is especially important with textured implants.
If you have saline implants, Mycometrics and Real Time can test saline fluid for mold and microorganisms.
See the Pathology for more information.
7. Other Explant Related Information:
Using drains post-surgery is a surgeon preference, it seems most use drains but there are some that do not – in both cases ladies have healed well. Pros: drains are primarily used to collect excess fluid that may accumulate which can prevent seromas (pocket of fluid buildup), infection (fluid buildup can be a breeding ground for bacteria), hematoma (a buildup of blood if there was excessive bleeding during the surgery), swelling and pain (fluid buildup can cause pressure on the incision site and to adjacent blood vessels, nerves, etc). Cons: they may increase risk of infection the longer they are in you, because they can be a pathway for bacteria to get inside. Fluid buildup can result from how complicated a surgery is, such as if there is an infection, more surgical trauma (if there is a lot of surgical dissection, if there is excessive bleeding, etc.), or a lot of dead space (area where the implants previously were). The top explant surgeons generally do use drains to help with fluid accumulation, see Drains in Explantation Surgery by Dr. Chun on YouTube. Ladies have healed well without the use of drains as well.
In the majority of cases the muscles and nerves will naturally reattach themselves and bond together. There are some instances however when muscles need to be reattached. Not all surgeons are skilled in it or choose to do it. If you are getting muscle repair make sure your surgeon is using dissolvable stitches and not anything permanent.
Removing lymph nodes is a controversial topic. Foreign substances in the breast have the potential to migrate to local and occasionally distant lymph nodes. Silicone from ruptured or intact implants can be found in lymph nodes. Textured implants can have shell fragments flake off and those may also be found in the lymph nodes and be associated with ALCL. Lymph nodes are an important part of the immune system and they help the body recognize and fight off infections. Silicone and shell fragments are very difficult to break down and therefore removal of large silicone-filled lymph nodes may be appropriate in some cases.
“Dr. Lu-Jean Feng has performed extensive research on silicone lymphadenopathy over the last 20 years as a result of breast augmentation. As a result of this research, she has published a peer-reviewed paper [Pathology of Lymph Nodes From Patients With Breast Implants] with scientists from the Armed Forces Institute of Pathology in Washington, D.C. as well as from Case Western Reserve University in Cleveland.
The study concluded that silicone in the lymph nodes can be diagnosed by ultrasound and localized by needle localization for precise removal. The polyurethane covered gel filled breast implants are associated with extensive silicone lymphadenopathy in the axilla, retropectoral, internal mammary, and sometimes neck nodes, but never in nodes below the diaphragm. The saline implants are never associated with silicone lymphadenopathy. Ruptured gel implants are only sometimes associated with silicone lymphadenopathy.”
Dr. Lu-Jean Feng’s Webinar Transcript, pg. 9:
“The silicone in the lymph nodes first has to be detected by ultrasound, which is probably the best way because it has a very specific signal. But to remove it you really have to have it needle localize, meaning that particular node has to be specified through needle localization and that can only be done by a radiologist. You can’t tell which [lymph nodes] have silicone and which [lymph nodes] do not if you just blindly go into the axillary space. They really have to be localized. Most of the silicone that I see in the lymph nodes are incredibly small and not alway accessible.
Some of this silicone lymph nodes are actually behind the ribs. They are very close to the lung, and the only way to remove these lymph nodes is to take out a rib to remove them. Some silicone in the lymph nodes are very high up in the chest near the axillary vessels. They are very hard to be localized. So, yes, you can approach it in those areas but which ones are you going to take? Are you going to take it all or are you going to take a few? So, unless the lymph node can be localized I wouldn’t take them out because you could take out normal lymph nodes and that certainly wouldn’t be good.
So if the lymph node is enlarged, if the lymph node is painful, if the lymph nodes can be localized, then these are all the conditions in which you could take our the lymph node. Otherwise if it too small, too inaccessible, you can’t get to it. The most important thing is how did it get there? So it is more important to remove the implant and capsules that really remove the secondary effect of implantation.”
Obtain a Copy of Operative Reports
It can be useful to have a copy of your implantation operative report for your records and to see any information on the implants such as manufacturer, size, and serial numbers. Previous operative reports are especially helpful If you are doing explant and lift and you have a history of previous breast lifts. Those operative reports can help to see what was done and help to figure out what adjustments need to be made to safely perform the procedure while maintaining circulation to prevent nipple necrosis, which is a risk if there are been previous lifts done.
After explant request a copy of your explantation operative report. You can read if the capsule was fully removed and any other surgical details.
Operative reports are part of your medical record and good to have. They provide a description of what was done to you while you were unconscious under general anesthesia. It is important to keep your own file of all pertaining medical records. How long medical offices are required to retain medical records varies with state. For more information you can read more on requesting medical records. Additionally, they are good to have if you are interested in legal avenues.
You can set your body up for a successful surgery by eating well and nourishing your gut. Fuel your mind and body with excellent nutrition: an organic whole foods diet, bone broth, lots of greens and cruciferous vegetables, beets, lentils, beans, iron, etc. The gut, is often referred to as the body’s second brain and is also where 70% of the immune system lies. It plays a very important role in the well being and balance of the body. Keep the gut flora healthy with high quality probiotics. Generally two weeks before surgery you are requested to stop supplements and medications. Arnica is generally allowed to be taken the days before surgery up through the first week post-opp.
Diet: Prepare the bowels and liver so they can be at their best for before and after surgery. Eat non-constipating foods high in fluid content and fiber (soups, cooked grains), beets are exceptionally good pre-surgery, and avoid constipating foods (dairy, meat). The liver takes the hardest hit from surgery, it has to process the anesthesia, drugs, and medications. Red beets and beet juice help protect the liver and help it to heal faster. Beets can come off strong on the liver so start small and work your way up. Bone broth soup contains collagen, gelatin, and the amino acids glycine and glutamine, these all help protect the gut. This soup is good to take before and surgery. Beans and lentils provide protein and fiber. Spinach is rich in iron and folate which help with methylation/detoxification. Read more on Health Eating Before & After Surgery.
Avoid preservatives with silicon in them, such as silicone dioxide or silica. Many of us become sensitized to the chemical silicone and its natural derivative silicon. Other preservatives and additives may be good to avoid as well, such as titanium dioxide, magnesium stearate, calcium carbonate, and potassium sorbate.
Heat is not advised until after explant, especially if one is symptomatic. This may be in the form of jacuzzi, sauna, infrared, tanning beds, and sun tanning. These may attribute to the breakdown and spread of implant toxins (silicone, heavy metals, and chemicals), therefore redistributing them and worsening symptoms. Detox therapeutics and treatments are also advised to wait off until after explant for similar reasons. They are recommended for usage a few months after explant and can be a good source of detoxification.
Post-Surgery Preparation & Tips
Shortly after explant you may notice symptoms from breast implant illness start to clear, but also the negative anesthetic and surgery effects of constipation, bloating, soreness, itching, numbness and burning as the nerves reconnect.
In the first few days following explant you can anticipate heavy constipation and bloating from the pain killers used during and after surgery. Narcotics slow down your intestines, even as they wear off. Water retention from the IV’s is common too, water tends to move and be retained downward with gravity. Antibiotics can also contribute to bloating as many of us suffer from fungal infections, such as candida, which thrive in the presence of antibiotics. A compression bra can help to minimize swelling. Maximum swelling is at 3-5 days post surgery and should resolve within 14 days.
You might have drains put in. The body makes fluid in response to the capsules being removed and this fluid generally is removed until each breast produces less than 30cc of fluid. Small clots in the drain fluid are normal.
- Probiotics are good to take with the use of antibiotics to protect the gut.
- Arnika Forte pellets – combination of Arnica, bromelain, and antioxidants to reduce swelling/pain
- Liquid pure Aloe Vera (not concentrated or diluted versions), magnesium citrate (Calm), Vitamin C, and spoonfuls of healthy oils (avocado, coconut, flaxseed) help bowel movement. Smooth Move tea can also help relieve constipation.
- Bone broth soup and whole foods with fiber restore your gut’s lining and reduce intestinal inflammation. Other foods: Beets help protect the liver, spinach for iron and folate to help with methylation/detoxification, beans and lentils for protein and fiber, pineapple for the bromelain proteolytic enzyme which helps reduce inflammation and swelling. Gelatin from a beef source (such as bone broth) provides structural support and is good for healing.
- Drink plenty of fluids to flush out the anesthesia and narcotics.
- Lightly massage your breasts to stimulate the body’s nerve sensation as nerves reconnect.
- Arnica gel to massage on the breasts after your post-opp visit.
- Some people may also need antifungals.
A shirt that buttons up from the front or a zip up hoodie is helpful to prepare, so you don’t have to lift your arms up. You might want to purchase post-operative compression bras or front-close sport bras, if they are not provided. Fruit of the Loom are popular and economical (two bras for about $10), they are 100% cotton and are found at certain Walmart locations. Wedge pillows and straws are also popular and can be found at Bed, Bath, & Beyond or a similar retailer.
Lymphatic drainage massages are helpful post-surgery to support the lymphatic system in movement and flushing out wastes. The lymphatic system is a network of lymph nodes and lymphatic capillaries and vessels that also form a part of the immune system. They collect and help remove microbes, debris, bacteria, and excess fluids. There isn’t an active pump for the lymphatic system like there is with the blood which has the heart, the lymphatic system functions most when there is movement and skeletal muscle contractions. The lymphatic system has a uni-directional flow towards the heart. There are two ducts, the right lymphatic duct and the left thoracic duct, that are near the neck and drain the lymph fluids into the bloodstream. Interestingly, the left thoracic duct “drains a much larger portion of the body than does the right lymphatic duct.” In the breast implant illness groups there seems to be many women who have issues on the left side of their bodies. Lymphatic drainage massages are helpful because the post-surgery healing environment involves a lot of rest, this creates stagnancy, lymphatic congestion, and more inflammation. The lymphatic system can be boosted with the massages to increase lymph flow, improve immune function, clear blockages, eliminate toxins and wastes, and reduce inflammation.
Hyperbaric oxygen chamber treatment (HBOT) can help in post-surgery healing. It assists with reducing inflammation/swelling, healing tissues, and much more. Most therapeutics are recommended to wait on doing until at least a month to a few months post-surgery, except for HBOT which can generally be done shortly following surgery for its healing and regenerative potentials. If interested, advise with your surgeon. Read more about it here.
Medical Necessity Letter
For many of us this surgery is a medical necessity due to the debilitating severity of the symptoms. Even if you don’t have insurance, which is usually the primary purpose of this letter, it may be good to discuss this with your surgeon so you can have it for your medical records and to show your other health providers.
Some insurance companies realize that removal of breast implants can be medically necessary for women’s health to improve and will offer policies to cover the removal surgery. Obtain a copy of your insurance policy and review it to see if they are likely to pay for the removal. Generally, the insurance criteria focus on capsular contractures, ruptures, and pain. Accompany a medical necessity letter with the specific insurance codes. The process of getting approved may require tenacity and perseverance, if you get denied the first time repeal as many times as necessary. Don’t get discouraged, one lady reapplied three times and then was approved.
Please refer to the insurance page for information on insurance codes, which insurance companies have covered women, and contacts for assistance.
Breast implants usually have a warranty of 10 years and the coverage may be solely related to ruptures or capsular contractures. If you don’t know your implant manufacturer, you can contact your implanting surgeon and request your operative report and medical records. Please pay caution and be aware you may be signing away your rights to any future legal proceedings by accepting a warranty reimbursement. If you wish to proceed with a warranty, contact your surgeon and the manufacturer.