Source: Thailand Medical News Oct 24, 2019 5 years, 4 weeks, 1 day, 14 hours, 48 minutes ago
In 2018, a total of 2.6 million
breast implant surgeries were done globally according to official data collated from suppliers and various aesthetics and plastic surgery boards. This figure does not constitute unofficial
breast implant surgeries done in countries like South America, Mexico, China, India, Vietnam, Thailand and Philippines. In 2017 the official number of
breast implants done globally were about 1.48 million.
Since 2009, the US FDA had received more than 350,000 incidence reports about complications and diseases that arose as a result of
breast implants. The International Consortium Of Investigative Journalists (
Thailand Medical News is a member of this consortium) exposed in November 2018,that the US FDA had allowed manufacturers to bury so-called adverse event reports using a program known as “alternative summary reporting.” Once the US FDA began requiring more complete disclosure, the number of injuries and other incidents from
breast implants surged, from a few hundred a year to more than 4,000 in 2017 and more than 8,000 in the first half of 2018.
But even those numbers are overshadowed by the agency’s latest disclosure . About 90,000 reports came into the agency just in those two years, according to the US FDA. Globally the incidence of complications, diseases and even deaths have risen with more than 273,000 incidences reported globally for 2018 based on data collated from 42 countries. In the UK alone, the health regulators received about 1,480 serious incidences associated with
breast implants in 2018.
One in five women who receive
breast implants will get them removed within a decade due to complications such as rupture, deflation and the painful contraction of scar tissue around the implant, known as capsular contracture.
Breast implants are also blamed by tens of thousands of patients, and a growing number of medical professionals, for a range of autoimmune-related ailments generally referred to as breast implant illness.
A common incidence was a rare form of cancer called
FFF00">breast implant associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is not a breast cancer, but a cancer of the immune system. Studies have shown that patients with a kind of implant known as a textured implant face a higher risk of BIA-ALCL.
Textured implants produced by leading manufacturer Allergan were suspended from the European and Brazilian markets in December 2018 after losing their European certification. In February 2019, a French government inquiry recommended that one brand of textured implants, Allergan Biocell, should be permanently banned. In February 2019, the US FDA sent a letter to health providers across the U.S. warning them about the association between implants and BIA-ALCL.
Many more incidences involving allergies, pain, migration of implants, rupture and unexplained manifestations were also reported.
One of the growing trend of incidences is that most women after about 6 to 10 years of having the
breast implants start developing infections as the body starts to change and reject the implants. Often, the patients are left with very bad scarring and disfigurements after surgery to remove these implants.
As result of growing pressure and also court and legal cases filed against the US FDA, the regulatory body is starting to make changes such as requiring prospective
breast implant patients to be made aware of possible risk, a boxed warning and a checklist outlining potential harms, such as pain, fatigue and further surgery.
The US FDA wants
breast implant makers to warn women that breast implants are not lifetime devices, and that the risk of complications rises the longer a patient has the implant. Also, additional surgery may be required to treat the complications. Other possible complications include a risk of developing
breast implant-associated anaplastic large cell lymphoma cancer.
Breast implant makers should also include a checklist at the end of a patient informational booklet or brochure to help guide discussion when a woman is consulting with a surgeon, the US FDA is suggesting.
Besides giving patients the opportunity to review the specific risks of b
reast implants, the checklist should encourage them to ask about the surgeon's experience, education, training and credentials. The draft guidance also includes revised rupture screening recommendations for patients with silicone gel-filled
breast implants. Currently, MRI screenings are recommended beginning three years after implantation and every other year thereafter.
The US FDA new guidance proposes that patients without symptoms undergo either ultrasound or MRI screening five to six years after implantation and every two years thereafter. An MRI is recommended for patients who have symptoms at any time or uncertain ultrasound results for
breast implant rupture.
But unfortunately in countries like South Korea, Japan, China, Thailand and Vietnam, regulatory entities are not doing enough to warn prospective patients about
breast implants plus many greedy plastic surgeons do not want to disrupt their multi-million dollar businesses revenues. One Aesthetic clinic in Bangkok handles like 110 such surgeries a month while another hospital in Charansanitwong area known to many as the ‘meat factory’ ie for its cheap but fast turnover times for a variety of surgeries, and with doctors who see OPD patients in their blood drabbed surgical outfits! handles close to 290 such procedures per month!
Females are warned that before embarking on such procedures for
breast implants to properly do due diligence with regards to such procedures and its effects and also to consult a psychologist to deal with image issues and acceptance before embarking on such procedures. It does not pay to look attractive sexually for a while but to suffer serious consequences later.
