Implant Complications
Complications
Surgeries involving breast implants, whether for cosmetic or reconstructive surgery, carry risk common to many types of surgery. These include adverse reactions to anesthesia, post-operative bleeding (hematoma)or fluid collection (seroma), surgical site infection or breakdown, breast pain or alterations in sensation [61][62][63] , unfavorable scarring (6-7%) [61][62], interference with breast feeding, visible wrinkling, asymmetry, thinning of the breast tissue, and symmastia (disruption of the natural plane between breasts which is sometimes referred to as ‘bread loafing’). Complications and reoperations related to surgeries with breast implants or tissue expanders can add significant long term costs to patients and health care systems.
Specific complications to indwelling breast implants that have received notable attention involve surveillance and treatment for implant rupture and the phenomena of capsular contracture.
[edit] Rupture
Breast implants can potentially remain intact for decades in the body, but all such devices will fail at some point.[citation needed] When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.[60]
Among the suspected mechanisms for rupture are damage during implantation or other procedures, degradation of the implant shell, blunt or penetrating chest trauma, and in rare instances from the pressure of traditional mammograms.[64]
The age and design of the implant are the most important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult, as most previous reports[65] mixed heterogeneous groups of devices in non-randomized populations. The only available literature with longer term available MRI data on single lumen 3rd/4th generation silicone implants comes from Europe and has reported silent rupture rates of an implant at between 8% to 15% at or around a decade (or 15-30% of patients).[66][67][68] The first series of MRI evaluation of the highly-cohesive (5th generation) gel implants suggests improved durability, with a rupture rate reported at 1% or less at a median age of six years.[69]
Its been suggested that clinical exams alone are inadequate to evaluate suspected rupture after a study reported that only 30% of ruptures in asymptomatic patients are accurately detected by experienced plastic surgeons, compared to 86% detected by MRIs [70] The US-FDA has recommended that MRIs be considered to screen for silent rupture starting at three years after implantation and then every two years thereafter.[61] Other countries have not endorsed routine MRI screening, and have taken the position that MRI should be reserved only for cases involving suspected clinical rupture or to confirm mammographic or ultrasound studies suggesting rupture.[50]
When silicone implants break they rarely deflate, and the silicone from the implant can leak out into the space around the implant. An intracapsular rupture can progress to outside of the capsule (extracapsular rupture), and both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate, but most clinical complications have appeared to be limited to the breast and axillae [71] in the form of granulomas (inflammatory nodules) and axillary lymphadenopathy [72] (enlarged lymph glands in the armpit area).[73] The specific risk and treatment of extracapsular silicone gel is still controversial.
[edit] Capsular contracture
Capsules of tightly-woven collagen fibers form as an immune response around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics), tending to wall it off. Capsular contracture occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be very painful and distort the appearance of the implanted breast. The exact cause of contracture is not known. However, some factors include bacterial contamination, silicone rupture or leakage, and hematoma. Capsular contracture may happen again after this additional surgery.
Methods which have reduced capsular contracture include submuscular implant placement, using textured[74][75] or polyurethane-coated implants,[76] limiting handling of the implants and skin contact prior to insertion[77] and irrigation with triple-antibiotic solutions.[78]
Correction of capsular contracture may require surgical removal or release of the capsule, or removal and possible replacement of the implant itself. Closed capsulotomy (disrupting the capsule via external manipulation), a once common maneuver for treating hard capsules, has been discouraged as it can cause implant rupture. Nonsurgical methods of treating capsules include massage, external ultrasound,[79] treatment with leukotriene pathway inhibitors (Accolate, Singulair),[80][81] and pulsed electromagnetic field therapy.[82]
Infection
Like all foreign bodies placed in the body such as dental implants, orthopedic prosthesis and heart valves etc, breast implants are subject to a risk of infection. This ranges from 1-2% and if affected, the patient will feel feverish, tenderness on the breast and swelling with possible redness.
Most infections are readily treated with intravenous antibiotics, and resolve completely. However, some implants need to be removed and replaced after the infection has settled down.
Implant infections can occur within the first few weeks post-operatively, or many weeks after the surgery.
Implant Palpability
The following may cause implants to be more palpable (more easily felt) or more visible: textured implants; larger implants; sub-glandular placement; and smaller amount of skin/tissue available to cover the implant.
Non-FDA Approved Implants
It is probably better to choose a brand of implant that is FDA approved, due to the stringent quality control measures imposed by the FDA. Here is an example of complications arising from using non-FDA approved implants.
France recalls breast implants after fraud, leakage
Posted: 31 March 2010 0219 hrs
Photos 1 of 1
Silicone breast implantPARIS – French health authorities said Tuesday they had ordered a recall of a certain type of breast implant after it emerged that the company making them had fraudulently used non-authorised silicone gel.
The agency that oversees health care products here, the AFSSAPS, also ordered a ban on new sales of the implants, which are made by the French company Poly Implant Prothese (PIP).
Around 90 percent of PIP’s breast implants are exported.
Between 35,000 and 45,000 women have had an implant supplied by the French company since 2001, said Jean-Claude Ghislain of AFSSAPS, adding that up to 1,000 of them will get a replacement.
The agency said it began investigating the company’s products after it had been informed of abnormally high rupture rate of PIP’s implants, which was double that of implants from other companies.
Inspectors were sent to the firm’s production sites in southern France where they discovered that PIP was using a type of silicone gel that had not been approved by health authorities.
“Therefore these were products that had not been evaluated,” Ghislain said, adding that what he called “the fraud” had been going on for several years.
He said that unsuitable gel could damage the shell which contains it and thus could leak more easily than approved gel, which might explain why PIP implants had such high rupture rates.
Ghislain noted that breast implants normally have a lifespan of ten years.
- AFP /ls
(Reproduced from ChannelNewsAsia)
