The rupture rate of current implants is estimated to be around 5% at 10 years, with no major differences between the brands on the market. In 2010, however, the Spanish Agency for Medicines and Health Products (AEMPS) recommended the withdrawal of all PIP breast prostheses, given that although they did not present an inherent risk to the health of the patient, they did present a greater risk of rupture than the rest of the prostheses on the market, which could lead to complications such as irritation, inflammation and increase the risk of later complications.
Implant rupture may go unnoticed, “silent rupture” or not. In some cases, the rupture may be secondary, produced by repetitive microtrauma such as muscle contraction or a great direct trauma to the prosthesis (for example the car belt during a car accident traffic). There are also breakages without any justified cause. Therefore, the patient may not remember the event that could trigger the rupture.
After rupture, different clinical signs may or may not be observed:
- Alteration of the shape of the breast: occurs above all in those old prostheses with low cohesiveness, in which the silicone gel migrated out of the prosthesis. The rupture, in case of being extracapsular, produces the exit of the silicone out of the periprosthetic capsule, spreading through the tissues and giving rise to an inflammatory process, even forming siliconomas (granulomatous-type inflammatory response to a foreign body, which covers the silicone in the form of nodules). It is easily diagnosed by imaging studies (MRI is the best diagnostic test) and requires surgical removal.
- Pain and inflammation of the breast: In the case of extracapsular tears, the leakage of silicone and contact with the surrounding tissues causes an inflammatory process that can be painful.
- Capsular contracture: This is an increase in the hardness of the normal capsule that surrounds the implant. Said contracture is classified by degrees according to the hardness, deformity, and pain it causes in the patient. Contracture can appear for several causes, but one of them is usually the rupture of the implant.
- Silent rupture: It occurs above all with the latest generation implants, although they are rare. Given the high cohesiveness, there is no migration of the silicone and the implant maintains a large part of its shape, which is why a deformity in the breast is not seen externally, which means that the patient does not notice the break and the diagnosis is incidental during routine breast check-ups to rule out breast cancer.
The fact of wearing a breast prosthesis has not been shown in scientific studies to increase the risk of breast cancer, nor to reduce the ability of imaging tests to diagnose it. However, it could have an influence the existence of a certain degree of capsular contracture at the time of breast self-examination, since the patient could attribute some alteration in her breast to it, which could translate into a delay in the diagnosis of a breast injury. For this reason, it is of the utmost importance that the patient undergoes a control by imaging test (usually ultrasound) at least once a year to assess her breasts and the status of the prostheses.
Although it has not been shown that the use of wearing a breast prosthesis is related to the increase in the incidence of breast cancer, there were some ideas about anaplastic large cell lymphoma and its relationship with prostheses. The American FDA issued a statement in 2011 in which they had evidence of about 60 cases, the current incidence being estimated at around 3 out of 100 million women, a figure that seems small when compared to the 10 million women in the world who are currently users of breast prostheses. This type of cancer affects the lymphatic system, specifically T lymphocytes, and although it can appear anywhere in the body, the one associated with breast prostheses only appears in the periprosthetic capsule. Treatment consists of surgical removal of the implant and periprosthetic capsule, and in the event of extracapsular involvement treatment can be complemented with chemotherapy and / or radiotherapy, obtaining good results in the survival of the patient. All the studies that currently exist in this regard, however, have not demonstrated a causal relationship, so currently, silicone implants are still considered safe and the only recommendation is to continue with routine controls, taking into account that in case of the appearance of a late seroma, the existence of ALCL must be ruled out.
Formation of the capsule around the implant is a normal process, but it becomes a problem when this capsule contracts. Said increase in the firmness of the capsule has been related to many factors such as: the type of implant cover, the existence of bacteria that colonize the implant, the microtrauma that occurs during surgery, etc.
Depending on the type of degree of contracture, the patient will notice the palpation in breast much firmer than usual, a deformity in the previous shape of the breast and in advanced cases pain due to the compression that the contracture exerts on the tissues.
When the deformity is noticeable and pain appears, surgical removal of the periprosthetic capsule and prosthetic replacement are required. Imaging studies of the breast are previously performed to assess the status of the prosthesis in order to schedule surgery.
It is associated with microtrauma on the periprosthetic capsule, which produces an inflammatory process with the consequent production of seroma, which accumulates within the periprosthetic capsule, causing a unilateral and painful breast enlargement, with secondary appearance fibrous capsular contracture in up to 80% of cases. Its treatment involves capsulectomy and replacement with a polyurethane-wrapped prosthesis. The existence of anaplastic giant cell lymphoma should be ruled out in all late seromas.
It is a very rare to happen. It occurs secondary to a systemic infection and in which the patient has a weakened immune system, being able to colonize the implant capsule. Broad spectrum antibiotic treatment can be tried and if improvement does not occur, implant removal would be indicated.
The implant is located in a pocket that is made to a measure at the time of its placement, either below the pectoral muscle or below the mammary gland. Over time and depending on the physical activity of the patient, there may be a displacement of the implant, which shows a change in the shape of the breast and an asymmetry with the contralateral breast. Sometimes and especially when anatomical prostheses are used (in the shape of a tear), these can be rotated within your pocket, the rotation rate being approximately 1%, causing a deformity and asymmetry in the breast. Maneuvers to try to correct the position with posterior bandage splinting have been described, but they present a high recurrence rate, so surgical management is usually indicated to reposition the implant and close the pocket.
BREAST IMPLANTS DO NOT LAST A LIFETIME
Although it has not been determined exactly what is the recommended time to perform a prosthetic replacement, it is often said that above 10 years it would be advisable to consider it. There are no scientific studies or recommendations by manufacturers or the Ministry of Health, about when to change a breast implant, so there are patients with implants placed 20 years ago who do not present complications and therefore, carry their first implants.
This suggests that the younger the patient undergoes surgery, undoubtedly she will have to undergo some replacement surgery throughout her life, a fact that the patient must know before deciding to operate. In addition, you should know that you will need to control your implants through physical examination and imaging tests on a regular basis to ensure their good progress.
On the other hand, it is very clear that in the case of any of the complications described above a replacement surgery should be considered if the patient wishes to continue wearing a breast prosthesis. It is common practice that if they have already elapsed some years, it is normal to replace both prostheses and reset the counter “to zero” again.